130 results on '"Milleman, Jeffery"'
Search Results
2. Quantitative analysis of the effects of essential oil mouthrinses on clinical plaque microbiome: a parallel-group, randomized trial
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Min, Kyungrok, Glowacki, Andrew J., Bosma, Mary Lynn, McGuire, James A., Tian, Sandy, McAdoo, Kathleen, DelSasso, Alicia, Fourre, Tara, Gambogi, Robert J., Milleman, Jeffery, and Milleman, Kimberly R.
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- 2024
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3. Quantitative analysis of the effects of brushing, flossing, and mouthrinsing on supragingival and subgingival plaque microbiota: 12-week clinical trial
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Min, Kyungrok, Bosma, Mary Lynn, John, Gabriella, McGuire, James A., DelSasso, Alicia, Milleman, Jeffery, and Milleman, Kimberly R.
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- 2024
- Full Text
- View/download PDF
4. Efficacy of flossing and mouth rinsing regimens on plaque and gingivitis: a randomized clinical trial
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Bosma, Mary Lynn, McGuire, James A., DelSasso, Alicia, Milleman, Jeffery, and Milleman, Kimberly
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- 2024
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- View/download PDF
5. Habits, Practices and Beliefs Regarding Floss and Mouthrinse among Habitual and Non-Habitual Users
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Rotella, Katie, Bosma, Mary Lynn, McGuire, James A., Sunkara, Anusha, DelSasso, Alicia, Gaff, Megan, Milleman, Kimberly, and Milleman, Jeffery
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Dental floss -- Usage -- Health aspects ,Mouthwashes -- Usage -- Health aspects ,Oral habits -- Health aspects -- Evaluation ,Health - Abstract
Purpose: The purpose of this survey was to investigate how flossing and rinsing behaviors impact individual beliefs about oral disease risk, the efficacy of floss and mouthrinse, and the perceived benefits and barriers of floss and mouthrinse. Methods: Participants in this required component of a 12-week plaque and gingivitis randomized clinical trial on flossing and rinsing regimens completed a paper questionnaire prior to randomization and baseline/screening measurements. Results: All of the clinical trial participants (n=213) completed the questionnaire. Respondents were grouped as habitual or non-habitual users of floss or mouthrinse if the product was used at least once daily; 16% (n=34) were habitual users of floss and 17% (n=36) were habitual users of mouthrinse. Perceived barriers included fear of gingival bleeding and pain, forgetting, and not including flossing or rinsing as part of the daily oral care routine. Non-habitual users were less likely to believe in the intangible benefits of flossing or rinsing and much more likely to perceive barriers to using floss or mouthrinse. Risk perception of developing oral disease was not shown to predict product usage. Respondents viewed their risk of developing gingivitis as relatively low despite this diagnosis being confirmed clinically among the participants. Conclusion: While respondents strongly believed that brushing, flossing, and mouthrinse use carry unique benefits and that combining all three methods would be optimal, these respondents still had high perceived barriers to using floss and mouthrinse regularly and consequently these habits were not included in their daily oral hygiene regimen. Understanding the perceptions regarding oral health behaviors may help drive more effective interventions and assist practitioners in improving their patients' oral health outcomes. Keywords: dental floss, mouthrinse, oral hygiene habits, health behaviors, gingivitis, Introduction Dental floss is one of the most commonly recommended interdental cleaners because of its ability to reach between the teeth, where toothbrush bristles are not able to easily access, [...]
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- 2022
6. Role of Manual Dexterity on Mechanical and Chemotherapeutic Oral Hygiene Regimens
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Milleman, Kimberly, Milleman, Jeffery, Bosma, Mary Lynn, McGuire, James A., Sunkara, Anusha, DelSasso, Alicia, York, Tori, and Cecil, Angela M.
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Motor ability -- Health aspects ,Gum diseases -- Care and treatment ,Mouth -- Care and treatment ,Gingivitis -- Care and treatment ,Dental care -- Physiological aspects -- Patient outcomes ,Dental hygiene -- Physiological aspects -- Patient outcomes ,Health - Abstract
Purpose: Effective use of mechanical plaque control devices can depend on individual manual dexterity levels. The purpose of this component of a 12-week, virtually-supervised clinical trial was to investigate the role of manual dexterity on clinical outcomes for gingivitis, as measured by the relationship between manual dexterity scores on the Purdue Pegboard Test (PPT) and the effects of various mechanical and chemotherapeutic oral hygiene regimens. Methods: This was a single-center, examiner blinded, randomized, four-treatment arm, parallel group, 12-week plaque and gingivitis study. At baseline, healthy adult volunteers with evidence of gingivitis were assessed for manual dexterity and were then examined for plaque, gingivitis and bleeding. After a dental prophylaxis, participants were randomized into four treatment groups: brush only (BO); brush/rinse (BR); brush/floss (BF); and brush/floss/rinse (BFR). The flossing groups received instruction in flossing. The PPT was used to assess manual dexterity and was performed by a licensed occupational therapist. Virtual supervision was required once each weekday and the oral hygiene regimen was unsupervised on evenings and weekends. Results: Of the 213 subjects enrolled, 209 completed the trial. Improvements from baseline to week 12 in interproximal percent nonbleeding healthy sites (Expanded Bleeding Index (EBI)=0 and Modified Gingival Index (MGI)=0 or 1) were dependent on the participant's dexterity score. Participants with the lowest dexterity scores (9 or lower) in the BFR treatment group demonstrated the greatest improvement interproximally based on the indices (EBI and MGI). In comparison, the BF test group subjects with dexterity scores 9 or lower had limited change in improvement interproximally. There was a direct correlation between flossing effectiveness and dexterity scores. Conclusions: Less manual dexterity can limit dental flossing effectiveness. Flossing is a difficult daily task that requires functional bilateral dexterity to be perform correctly. Individuals with lower levels of manual dexterity were shown to benefit from the addition of an essential oil mouthrinse to a regimen of toothbrushing and flossing in this clinical trial. The addition of an essential oil mouthrinse improved interproximal gingival health and mitigated the manual dexterity variable. Keywords: manual dexterity, Purdue Pegboard Test, plaque control, flossing, toothbrushing, mouthrinses, essential oils, Introduction Oral disease is a global health challenge with significant health and economic burdens on populations across the lifespan. (1) Dental caries and periodontal disease are among the most prevalent [...]
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- 2022
7. Comparative Effectiveness of Toothbrushing, Flossing and Mouthrinse Regimens on Plaque and Gingivitis: A 12-week virtually supervised clinical trial
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Milleman, Jeffery, Bosma, Mary Lynn, McGuire, James A., Sunkara, Anusha, McAdoo, Kathleen, DelSasso, Alicia, Wills, Kaylie, and Milleman, Kimberly
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Dental floss -- Usage -- Health aspects ,Dental plaque -- Care and treatment ,Toothbrushing -- Health aspects ,Mouthwashes -- Usage -- Health aspects ,Gum diseases -- Care and treatment ,Gingivitis -- Care and treatment ,Health - Abstract
Purpose: Various mechanical and chemotherapeutic methods are used to control dental plaque accumulation and prevent or reduce gingivitis. The purpose of this 12-week clinical trial was to investigate the effects of various combinations of supervised mechanical and chemotherapeutic regimens on the prevention and reduction of plaque, gingivitis, and gingival bleeding. Methods: Volunteers presenting with some evidence of gingivitis and no severe periodontitis were randomized into four groups: brush only (BO); brush/rinse (BR); brush/floss (BF); brush/floss/rinse (BFR) for this examiner-blinded clinical trial. Toothbrush, toothpaste, floss and a mouthrinse containing a fixed combination of four essential oils (EO) and training/ instructions were provided to participants as per their assigned group. Participants performed their regimen at home, under virtual supervision, once each weekday; the second daily and weekend uses were unsupervised. Assessments included oral hard and soft tissue, plaque, gingivitis, and gingival bleeding (weeks 4, 12); probing depth and bleeding on probing (week 12). Results: Of 213 enrolled participants, 209 completed the study. After 12 weeks, plaque, gingivitis, and gingival bleeding were significantly reduced in groups BR (35.8%, 50.8%, and 71.0% respectively, p Conclusions: Oral care regimens that included a mouthrinse containing a fixed combination of four EOs (BR and BFR), demonstrated statistically significantly reduced plaque, gingivitis, and gingival bleeding as compared to BO and BF after 12 weeks. The BF regimen statistically significantly reduced gingivitis and gingival bleeding but did not statistically significantly reduce plaque compared to BO after 12 weeks. Keywords: dental plaque, gingivitis, flossing, toothbrushing, essential oils, mouthrinses, Introduction Dental biofilm (plaque) is a primary etiologic factor in the two most widely prevalent dental diseases, caries and gingivitis, and is regarded as an underlying cause of gingival inflammation. [...]
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- 2022
8. Efficacy of Flossing and Mouthrinsing Regimens on Plaque and Gingivitis: A randomized clinical trial
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Bosma, Mary Lynn, McGuire, James A., Sunkara, Anusha, Sullivan, Pamela, Yoder, Abbie, Milleman, Jeffery, and Milleman, Kimberly
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Dental floss -- Usage -- Health aspects ,Dental plaque -- Care and treatment -- Prevention ,Mouthwashes -- Usage -- Health aspects ,Gum diseases -- Care and treatment -- Prevention ,Gingivitis -- Care and treatment -- Prevention ,Health - Abstract
Purpose: Flossing is a well-known component of daily recommended oral care regimens, but patients often find it challenging to perform effectively on a regular basis. The purpose of this 12-week supervised clinical trial was to investigate the effects of twice daily rinsing with a mouthrinse containing a fixed combination of four essential oils (4EO) and supervised daily dental flossing regimens as compared to a negative control 5% hydroalcohol rinse (NC) on the prevention and reduction of plaque, gingivitis, and gingival bleeding. Methods: Volunteer participants who met the inclusion criteria were randomized into the following groups for the 12- week trial: 1) NC; 2) mouthrinse containing 4EO; 3) professional flossing performed by a dental hygienist (FBH); 4) supervised self-flossing (FUS). All participants received a professional dental prophylaxis prior to beginning the trial. On weekday mornings, all participants brushed on site. After brushing, the rinse groups used their products under supervision, and the floss groups had their teeth flossed by a dental hygienist or self-flossed under supervision. Participants performed their assigned regimen in the evenings and the twice-daily weekend use at home. Each individual assessment of oral hard and soft tissue, plaque, gingivitis, and gingival bleeding at weeks 4 and 12, probing depth and bleeding on probing at week 12 was made by the same calibrated examiner. Results: Of 156 randomized participants, 149 completed the trial. Use of the 4EO mouthrinse statistically significantly reduced plaque, gingivitis, and gingival bleeding on probing after 12 weeks as compared to the NC rinse. Both flossing interventions statistically significantly reduced interproximal gingivitis and gingival bleeding at 12 weeks compared to the NC rinse; neither flossing intervention significantly reduced interproximal plaque after 12 weeks compared to the NC rinse. Conclusions: Rinsing with a 4EO mouthrinse statistically significantly improved all oral health outcome measures at all time points compared to a NC rinse in this 12-week clinical trial. While professional and supervised flossing improved gingival health compared to use of the NC rinse, statistically significant plaque reduction with dental flossing was not attained at the end of the 12-week trial. Keywords: dental plaque, gingivitis, essential oils, mouthrinse, chemotherapeutics, dental floss, oral health, Introduction Dental biofilm (plaque), a complex community of microbial cells, attaches to the tooth surface by embedding in an extracellular matrix. Changes in the structure of the microbial communities within [...]
- Published
- 2022
9. The effects of scaling and root planing plus home oral hygiene maintenance in Stage I/II periodontitis population: A 24‐week randomized clinical trial.
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Jenkins, Wendy, Starke, E. Michelle, Nelson, Melissa, Milleman, Kimberly, Milleman, Jeffery, and Ward, Marilyn
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PERIODONTITIS treatment ,HEMORRHAGE prevention ,DENTAL scaling ,PATIENT safety ,RESEARCH funding ,STATISTICAL sampling ,BLIND experiment ,ORAL hygiene ,HOME environment ,TREATMENT effectiveness ,RANDOMIZED controlled trials ,DESCRIPTIVE statistics ,CHI-squared test ,ANALYSIS of covariance ,TOOTH root planing ,DENTAL plaque ,ONE-way analysis of variance ,TOOTH care & hygiene ,CONFIDENCE intervals ,DATA analysis software - Abstract
Objectives: To compare the effects of powered and manual toothbrushing following scaling and root planing on bleeding on probing and other clinical indicators of periodontitis. Materials and Methods: This was a randomized, examiner‐blind, parallel‐design, 24‐week clinical study. Eligible subjects were 18–75 years of age with Stage I or II periodontitis. All subjects received scaling and root planing (SRP) within 28 days of enrollment. Thereafter, subjects were randomized to twice daily at‐home use of either a powered toothbrush (PTB) or a manual toothbrush (MTB). Randomization was balanced for gender and periodontitis stage. No other oral hygiene aids were permitted. Subjects were evaluated every 4 weeks for the following measures: bleeding on probing (BOP), surface plaque (MPI), probing pocket depth (PPD) and clinical attachment level until Week 24. Results: Of 328 randomized subjects, 299 subjects completed the study. For BOP at Week 24, the Least Squares (LS) Mean, standard error (SE) reduction from baseline was 0.24 (0.01) for the PTB group and 0.02 (0.01) for the MTB group, resulting in a statistically significant treatment difference of 0.22 (0.01), p‐value < 0.0001. There were also concomitant reductions in MPI and PPD at Week 24, resulting in statistically significant (p‐value < 0.0001) LS Mean (SE) treatment differences of 0.86 (0.04) and 0.24 (0.01), for MPI and PPD, respectively. Conclusion: When combined with SRP, daily home oral hygiene maintenance including a powered toothbrush significantly reduced clinical symptoms of periodontitis and surface plaque levels compared to a manual toothbrush in a Stage I/II periodontitis population. (ClinicalTrials.gov Identifier: NCT04254770). [ABSTRACT FROM AUTHOR]
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- 2024
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10. Safety and Effectiveness of a Novel Color Corrector Serum for Causing Temporary Changes to Tooth Shade: A Randomized Controlled Clinical Study.
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Pascolutti, Mauro, Tomic, Alex, Milleman, Kimberly R., Milleman, Jeffery L., and Walsh, Laurence J.
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DECIDUOUS teeth ,TOOTH whitening ,COMMERCIAL product testing ,INCISORS ,TEETH - Abstract
Tooth color is a major driver of facial esthetics. While permanent changes in tooth shade can be achieved by bleaching and restorations, there is a need for cosmetic products that can cause reversible color changes. This randomized controlled clinical study assessed the effectiveness and safety of a novel color-correcting product (Hismile™ V34 Color Corrector Serum™) versus a placebo (vehicle control lacking the color-change dyes). A single-center, randomized, controlled, examiner-blind, two-group, parallel design, single-use study design was followed. The test products were applied on a cotton bud for 30 s, and then, rinsed off. Tooth shade for maxillary central incisors was measured at baseline, immediately, and at 30 and 60 min, using the Vita Bleachedguide 3D-Master
® Shade Guide and the EasyShade Advanced 4.0 spectrophotometer (for determining values of L*a*b*). The subjects (N = 60) had a baseline shade of 1M2 (rank 9) or darker. A single application of the test product resulted in an immediate and significant (p < 0.001) three shade improvement (26.2%) according to the shade guide, and the same significant benefits extended to 30 and 60 min. The placebo product did not alter tooth shade (p = 0.326). These changes were accompanied by significant improvements in the L value (whiteness) up to 30 min, and a reduction in b* (yellowness) for up to 60 min. Two-thirds of subjects using the test product stated in a survey that their teeth appeared both whiter and brighter. No safety issues arose from the use of the test product or vehicle control. These results indicate that using a color corrector can achieve worthwhile changes to tooth shade for up to 60 min. [ABSTRACT FROM AUTHOR]- Published
- 2024
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11. A Randomized, Parallel Design Study to Compare the Effects of Different Interdental Cleaning Modalities on Gingivitis and Plaque After a 6-Week Period of Home Use.
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Mirza, Farah, Nelson, Melissa, Ambers, Janice, Milleman, Kimberly, Milleman, Jeffery, and Ward, Marilyn
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GINGIVAL hemorrhage ,GINGIVITIS - Abstract
Tlie objective of this study was to evaluate the effectof different interdental oral cleaning modalities on gingivitis and plague following a 6-week period of home use. This was a randomized, four-arm, parallel design clinical trial. Study subjects were manual toothbrush (MTB) users with moderate to severe gingivitis, aged 18 to 65 years. Subjects were required at baseline to have a gingival bleeding score of -1 on at least 50 gingival sites per the Gingival Bleeding I ndex (GBI) and to have an overall plague score of 20.6 per the Rustogi Modified Navy Plague Index (RMNPI) following a 3- to 6-hour plague accumulation period. Subjects were randomly assigned to use one offouroral caircleaning niodalities: (1) NON group: MTB alone, (2) FLS group: MTB plus string floss, (3) IDB group: MTB plus an interdental brush, or (4) CPF group: MTB plus the Philips Sonicare Cordless Power Flosser with the Quad Stream nozzle. Efficacy measures (Modified Gingival Index [MGIl, GBI, and RMNPI) and safety were assessed at baseline. 2 weeks, and 6 weeks. The primary efficacy endpoint was the reduction in gingival inflammation from baseline to week 6 as ineasilred by the MG L Of the 372 subjects r:indomized in the study, 364 completed a post-baseline MGI evaluation and were included in the analyses. The adjusted mean percent reduction in gingival inflamniation from baseline to week 6 was -2.10% for the NON group, 2.82% fur the FLS group, 2.60% forthe IDB group, and 29.10% for the CPF group. Pairwise comparisons indicated that the CPF group was statistically significantly different from the NON, FLS, and IDB groups Of' < .0001). In conclusion, adjunctive use ofthe Philips Sonicare Cordless Power Flosser with the Quad Stream nozzle and an MTB showed statistically better results in term of reducing gingival inflammation following 6 weeks o f home use when compared to an MTB alone, an MTB used with string floss, and an MTB used With an interdental brush. [ABSTRACT FROM AUTHOR]
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- 2024
12. A Randomized, Parallel Design Study to Evaluate the Effects of Different Oral Cleaning Modalities on Gingivitis and Plague After a 6-Week Period of Home Use.
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JingRu Li, Mirza, Farah, Wang, Pin-Wen, Argosino, Krista, Milleman, Kimberly, Milleman, Jeffery, and Ward, Marilyn
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GINGIVAL hemorrhage ,GINGIVITIS ,GINGIVA - Abstract
The study objective was to evaluate the effect of di fferent interdental oral cleaning niodalities ort gingivitis and plague following a 6-week period of home use. This was a randomized, parallel, examiner-blinded study. Study subjects were routine manual toothbrush (MTB) users with moderate to severe gingivitis. aged 18 to 65 years. Subjects were required to have a gingival bleeding score of 21 on at least 50 gingival sites per the Gingival Bleeding Index (GBI) and to have a minimum average plague score of 20.6 per the Rustogi Modified Navy Plague Index (RMNPI) following a 3- to 6-hour plague accumulation period. Subjects were randomly assigned to one of four groups based on tile oral care cleaning modality: (1) NON group: MTB alone, (2) FLS group: MTB plus string floss, (3) MPF group: MTB plus a Philips'" Sonicare' Power Flosser with the Quad Stieam nozzle, or (4) PPF group: Philips Sonicare power toothbrush plus the power flosser. Safety and efficacy measures (Modified Gingival Index [MGI], GBI, and RMNPI) were assessed at baseline, 2 weeks, and 6 weeks. The primary efficacy endpoint was the reduction in gingival inflammation from baseline to week 6 as measured by the MGI. A total of 260 subjects were randomized and 256 subjects completed the study. The adjusted mean percent reduction iii gingival intlammation from baseline to week 6 was 14.90% forthe NON group, 13.16% for the FLS group, 33.51% forthe MPFgroup, and 49.30% forthe PPF group. Pairwise comparisons indicated that both the PPF and MPF groups were statistically significantly different from both the NON and FLS groups. In conclusion, lise of either the Philips Sonicare power toothbrush with the Philips Sonicare Power Flosser or an MTB with the Philips Sonicare Power Flosser was statistically superior to an MTB alone and an MTB used with string floss in reducing gingival inflammation following 6 weeks of home use. [ABSTRACT FROM AUTHOR]
- Published
- 2024
13. Clinical Assessment of Plaque Removal using a Novel Dentifrice containing Cellulose Microfibrils
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Labib, Mohamed E., primary, Perazzo, Antonio, additional, Manganaro, James, additional, Tabani, Yacoob, additional, Milleman, Kimberly R., additional, Milleman, Jeffery L., additional, and Walsh, Laurence James, additional
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- 2023
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14. A method development randomised clinical study investigating efficacy of an experimental oral rinse in providing long-term relief from dentinal hypersensitivity
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Milleman, Kimberly R., Milleman, Jeffery L., Young, Sarah, Butler, Andrew, Araga, Mako, and Atassi, Mounir
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- 2019
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15. Clinical Assessment of Plaque Removal Using a Novel Dentifrice Containing Cellulose Microfibrils.
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Labib, Mohamed E., Perazzo, Antonio, Manganaro, James, Tabani, Yacoob, Milleman, Kimberly R., Milleman, Jeffery L., and Walsh, Laurence J.
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DENTIFRICES ,CELLULOSE ,MICROFIBRILS ,DENTAL plaque - Abstract
Dentifrice performance in the removal of dental plaque is influenced by the interactions of dentifrice components with tooth surfaces. This randomized controlled clinical study assessed the effectiveness and safety of a novel fluoride dentifrice formulation that included a micro-fibrillated cellulose network with entangled microcrystalline cellulose and silica particles (Protegera
TM ), and compared this to a positive control fluoride dentifrice (Crest Cavity Protection™). Whole mouth dental plaque levels in 82 healthy adults were measured after the first supervised use, and following a week of twice daily use at home. Overall, the test dentifrice was at least three times and up to four times more effective in whole-mouth plaque reductions, with a 38.6% reduction on first use, a 30.9% reduction at day 7, and a 41.6% reduction from day 1 to day 7, compared to reductions of 12.0%, 9.6% and 11.6%, respectively for the positive control, and up to seven times more effective in lingual plaque reductions, than the reference dentifrice (p < 0.001), with a 27.7% reduction on first use, a 22.3% reduction at day 7, and a 31.0% reduction from day 1 to day 7, compared to reductions of 4.4%, 2.2%, and 4.5%, respectively, for the positive control. No safety issues arose from the use of the test dentifrice. These results indicate that including micro-fibrillated cellulose enhances plaque removal effectiveness, without causing adverse changes to oral soft tissues. [ABSTRACT FROM AUTHOR]- Published
- 2024
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16. A randomized clinical study to assess the performance of a marketed denture adhesive in a model of food infiltration in healthy, edentulous adults
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Patel, Nisha, primary, Varghese, Roshan, additional, Burnett, Gary R., additional, Atassi, Mounir, additional, Milleman, Kimberly, additional, and Milleman, Jeffery, additional
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- 2022
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17. Stain control with two experimental dentin hypersensitivity toothpastes containing spherical silica: a randomised, early-phase development study
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Mason, Stephen, Young, Sarah, Araga, Mako, Butler, Andrew, Lucas, Robert, Milleman, Jeffery L., and Milleman, Kimberly R.
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- 2019
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18. A randomized clinical study to assess the performance of a marketed denture adhesive in a model of food infiltration in healthy, edentulous adults.
- Author
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Patel, Nisha, Varghese, Roshan, Burnett, Gary R., Atassi, Mounir, Milleman, Kimberly, and Milleman, Jeffery
- Subjects
DENTURES ,ADHESIVES ,EDENTULOUS mouth ,PERFORMANCE theory ,ANALYSIS of variance - Abstract
Objectives: An optimized food infiltration methodology was utilized to assess the objective and subjective efficacy of a marketed denture adhesive regarding denture dislodgment and infiltration and perception of food particles under maxillary and mandibular dentures. A pilot study helped optimize methodologies before the efficacy study. Materials and Methods: Participants were healthy adults (n =48 for both studies) with fair‐ to well‐fitting and well‐made full maxillary and mandibular dentures. In the pilot, groups were a denture adhesive applied in a conventional dabbed‐on pattern, a denture adhesive applied in continuous strips, or no adhesive. In the efficacy study, groups were the Test denture adhesive (continuous strips pattern application) or no adhesive, employed in a crossover design. Food infiltration was investigated through measurement of peanut particle mass retrieved from under each denture (30–32 g chewed). No formal statistical testing was performed in the pilot. Statistical analysis in the efficacy study was performed using analysis of variance. Primary efficacy evaluation was combined peanut particle mass from both dentures. Secondary efficacy evaluations included peanut particle mass under separate dentures, participant‐reported denture dislodgements, and awareness/rates of how bothersome peanut particles under dentures were. Results: In the pilot, the median peanut particle mass was lower with either pattern application compared with no adhesive. In the efficacy study, peanut particle mass under combined dentures was lower with than without adhesive (geometric mean [product of values]: 5.56 vs. 29.13 mg) with a between‐group geometric mean ratio (adhesive over no adhesive) of 0.19 (95% confidence interval: 0.12, 0.30) favoring the Test adhesive (p <.0001). Similar Test adhesive beneficial outcomes in both studies included significantly fewer denture dislodgements and awareness and how bothersome peanut particles under dentures were. Treatments were generally well‐tolerated. Conclusions: These findings, including reduced peanut particle infiltration, fewer denture dislodgments, and lower ratings of bothersomeness, corroborate those studies investigating the benefits of denture adhesive in preventing food infiltration. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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19. A randomised controlled trial to evaluate the plaque removal efficacy of sodium bicarbonate dentifrices in a single brushing clinical model
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Bosma, Mary-Lynn, Milleman, Kimberly R, Akwagyiram, Ivy, Targett, Darren, and Milleman, Jeffery L
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- 2018
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20. Effectiveness of a calcium sodium phosphosilicate containing prophylaxis paste in reducing dentine hypersensitivity immediately and 4 weeks after a single application: a double-blind randomized controlled trial
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Neuhaus, Klaus W., Milleman, Jeffery L., Milleman, Kimberly R., Mongiello, Kimberly A., Simonton, Thomas C., Clark, Courtney E., Proskin, Howard M., and Seemann, Rainer
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- 2013
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21. Gingivitis Efficacy of a 0.454% w/w Stannous Fluoride Dentifrice: A 24-week randomized controlled trial.
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Parkinson, Charles Richard, primary, MILLEMAN, Kimberly R, additional, and MILLEMAN, Jeffery L, additional
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- 2020
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22. Four‐day plaque regrowth evaluation of a peptide chewing gum in a double‐blind randomized clinical trial
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Kirkwood, Brian, primary, Miller, Michael, additional, Milleman, Jeffery, additional, Milleman, Kimberly, additional, and Leung, Kai, additional
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- 2019
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23. Gingivitis Efficacy of a 0.454% w/w Stannous Fluoride Dentifrice: A 24-week randomized controlled trial.
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Parkinson, Charles Richard, primary, MILLEMAN, Kimberly R, additional, and MILLEMAN, Jeffery L, additional
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- 2019
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24. A Randomized, Crossover Trial to Evaluate the Effect of Two Mouthrinses on Plaque Regrowth in the Absence of Brushing.
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Nehme, Marc, Malpass, Katy, Butler, Andrew, Mason, Stephen, Kleber, Carl J., Milleman, Jeffery L., and Milleman, Kimberly R.
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DENTAL plaque ,MOUTHWASHES ,ANALYSIS of covariance ,CHLORHEXIDINE ,CONFIDENCE intervals ,CROSSOVER trials ,ENZYMES ,RESEARCH funding ,DATA analysis software ,DESCRIPTIVE statistics ,ODDS ratio ,PHARMACODYNAMICS ,THERAPEUTICS ,PREVENTION - Abstract
This study assessed the effects on plaque in the absence of brushing of two twice-daily mouthrinses, one with an enzymatic-based formulation (Biotène) and one with an antimicrobial chlorhexidine-based formulation (Peridex), and sterile water. Plaque levels were assessed in 23 participants using a 4-day, nonbrushing plaque regrowth model after twice-daily rinsing with sterile water (negative control), the enzyme-based mouthrinse, or the chlorhexidine-based mouthrinse (positive control). Peridex showed significantly greater prevention of plaque regrowth when compared with water and the enzyme-based Biotène mouthrinse. After 4 days, the enzyme-based mouthrinse was associated with a small but nonsignificant reduction in plaque regrowth compared with water. This study confirmed that Peridex is effective at prevention of plaque regrowth. Twice-daily rinsing with a Biotène formula that contained enzymes showed a small but nonsignificant trend toward prevention of plaque regrowth versus rinsing with water. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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25. A randomized clinical study to evaluate the effect of denture adhesive application technique on food particle accumulation under dentures
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Atassi, Mounir, primary, Milleman, Kimberly R., additional, Burnett, Gary R., additional, Sanyal, Susmita, additional, and Milleman, Jeffery L., additional
- Published
- 2019
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26. Efficacy of a 3% potassium nitrate mouthrinse for the relief of dentinal hypersensitivity
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Hall, Claire, primary, Sufi, Farzana, additional, Milleman, Jeffery L., additional, and Milleman, Kimberly R., additional
- Published
- 2019
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27. Randomized Controlled Clinical Study to Determine the Oral and Dermal Tolerability of an Experimental Denture Wipe
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Axe, Alyson, primary, Burnett, Gary R., additional, Milleman, Kimberly R., additional, Patil, Avinash, additional, and Milleman, Jeffery L., additional
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- 2018
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28. Safety and efficacy of a novel toothbrush utilizing RF energy for the reduction of plaque, calculus and gingivitis.
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MILLEMAN, KIMBERLY R., LEVI, LIORA, GRAHOVAC, TORI L., and MILLEMAN, JEFFERY L.
- Subjects
RADIO frequency therapy ,TOOTHBRUSHES ,GINGIVITIS ,CALCULUS ,DENTAL plaque ,BLIND experiment ,RADIO frequency - Abstract
Purpose: To evaluate the safety and efficacy of the ToothWave radiofrequency (RF) toothbrush in the reduction of plaque, calculus and gingival inflammation, as compared to a standard powered toothbrush accepted by the American Dental Association (ADA). Methods: This was a single-blind, double arm, prospective study. Subjects were randomized to one of two treatment groups, receiving either the RF powered toothbrush or a control powered toothbrush, and performing twice daily brushing for a test period of 6 weeks. Plaque (RMNPI), calculus (V-MI), gingival inflammation (MGI) and bleeding (GBI) were assessed at baseline, after 4 and 6 weeks. Comparisons were completed both within and between each treatment group. Statistical analyses were conducted using the Mann Whitney non-parametric model. Results: 85 subjects completed the study and had fully evaluable data. No significant differences between the groups were found in the baseline scores (P> 0.165). Following 6 weeks, the RF test group demonstrated statistically significant reductions in plaque, gingivitis and calculus compared to the control powered toothbrush (P< 0.001). Both toothbrushes were well-tolerated and no device-related adverse events were reported. The RF-utilizing powered toothbrush produced statistically significant reductions in dental plaque, calculus deposition, gingival inflammation and gingival bleeding as compared to a control powered toothbrush. [ABSTRACT FROM AUTHOR]
- Published
- 2020
29. Four‐day plaque regrowth evaluation of a peptide chewing gum in a double‐blind randomized clinical trial.
- Author
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Kirkwood, Brian, Miller, Michael, Milleman, Jeffery, Milleman, Kimberly, and Leung, Kai
- Subjects
DENTAL plaque ,ANTI-infective agents ,CHEWING gum - Abstract
Objective: Antimicrobial peptide, KSL‐W, formulated as an antiplaque chewing gum (APCG), was tested to evaluate the dental plaque inhibition activity and safety in an IRB approved and FDA regulated 4‐day plaque regrowth clinical study. Methods: This Phase 2 two‐armed placebo‐controlled, double blind, randomized (1:1), multiple dose, and single‐center study was evaluated in a proof of concept for the APCG containing 30 mg antimicrobial peptide KSL‐W. Twenty six generally healthy subjects were consented and randomized into the study. The subjects were administered a dose three times per day for four treatment days following a complete dental prophylaxis. Participants were prohibited from conducting oral hygiene care (teeth brushing, flossing, and/or mouth wash rinse) for the duration of the trial. Twelve to 16 hr prior to the baseline visit, the subjects were to abstain from oral hygiene care. The Quigley–Hein Turesky plaque index (QHT) score and the oral soft tissue clinical exams were obtained at both Day 0 and Day 4. Results: All randomized study subjects that received either APCG or placebo gum completed the study with no significant adverse events recorded. The APCG significantly inhibited the regrowth of dental plaque over the course of 4 days. The whole mouth data demonstrated a difference in the QHT between the APCG and the placebo gum of 1.14 (SE = 0.27) and 95% confidence bounds of 0.58, 1.70 with a two‐tailed P value of.0003. Conclusion: Considering the limited sample size, the proof of concept analysis in this Phase 2 study confirmed that APCG is effective against dental plaque formation and safe for human use. (ClinicalTrials.gov Study ID# NCT02864901). [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
30. Potassium oxalate mouthrinse reduces dentinal hypersensitivity
- Author
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Lynch, Michael C., primary, Perfekt, Roland, additional, McGuire, James A., additional, Milleman, Jeffery, additional, Gallob, John, additional, Amini, Pejmon, additional, and Milleman, Kimberly, additional
- Published
- 2018
- Full Text
- View/download PDF
31. Potassium oxalate oral rinses for long-term relief from dentinal hypersensitivity: Three randomised controlled studies
- Author
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Burnett, Gary R., primary, Gallob, John T., additional, Milleman, Kimberly R., additional, Mason, Stephen, additional, Patil, Avinash, additional, Budhawant, Chandrashekar, additional, and Milleman, Jeffery L., additional
- Published
- 2018
- Full Text
- View/download PDF
32. A randomized clinical trial to evaluate the stain removal efficacy of a sodium phytate dentifrice formulation
- Author
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Milleman, Kimberly R., primary, Creeth, Jonathan E., additional, Burnett, Gary R., additional, and Milleman, Jeffery L., additional
- Published
- 2018
- Full Text
- View/download PDF
33. Randomized Controlled Clinical Study to Determine the Oral and Dermal Tolerability of an Experimental Denture Wipe.
- Author
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Axe, Alyson, Burnett, Gary R., Milleman, Kimberly R., Patil, Avinash, and Milleman, Jeffery L.
- Subjects
DENTURES ,PARTIAL dentures ,COMPLETE dentures ,ADVERSE health care events - Abstract
Purpose: To evaluate oral and dermal tolerance following use and user acceptability of an experimental denture‐cleansing wipe. An exploratory objective was to develop a method to assess denture wipe effectiveness in removing debris from denture surfaces. Materials and Methods: This was a single‐center, randomized, controlled, parallel‐group, examiner‐blind study in participants with ≥1 full/partial denture. Participants were randomized to clean their dentures with the denture wipe (n = 76) or water (n = 76) up to 4 times per day for 14 days. Tolerability was assessed by treatment‐emergent adverse events (TEAEs), oral soft tissue examination, and lead hand dermatological assessment. Acceptability was assessed by questionnaire. The feasibility of a methodology to assess the efficacy of the wipe at removing food particles was also evaluated through determination of the mass of chewed peanut particles that the wipe removed after a single use (n = 31). Results: The proportion of participants experiencing oral TEAEs by day 14 was 0.039% with the denture wipe (lip injury [n = 1], mouth injury [n = 2]) and 0.013% with the water rinse (coated tongue [n = 1]). There were no dermal TEAEs and no TEAE‐related study withdrawals. Skin irritation scores with the denture wipe remained unchanged from baseline. Comparing before vs. after cleaning with the denture wipe, a higher proportion of participants rated their dentures as feeling extremely/very fresh (28.9% pre‐/85.5% post‐cleaning), feeling extremely/very clean (34.2%/86.8%) and looking extremely/very clean (43.5%/85.5%). More denture‐wipe group participants than water‐rinse group participants were extremely/very satisfied with the amount of debris removed from their dentures (88.1% vs 72.4%). The methodology used to assess the weight of peanut particles captured from the wipes/dentures appeared to be a feasible investigation technique. Conclusions: The denture wipe was generally well‐tolerated and had good user acceptability. The methodology for assessing the mass of peanut particles removed by denture wipes was successful. [ABSTRACT FROM AUTHOR]
- Published
- 2019
- Full Text
- View/download PDF
34. Effectiveness of a calcium sodium phosphosilicate-containing prophylaxis paste in reducing dentine hypersensitivity immediately and 4 weeks after a single application: a double-blind randomized controlled trial
- Author
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Proskin, Howard M., Neuhaus, Klaus, Mongiello, Kimberly A., Clark, Courtney E., Seemann, Rainer, Simonton, Thomas C., Milleman, Jeffery L., and Milleman, Kimberly R.
- Subjects
610 Medicine & health - Abstract
AIMS The aim of this single-site, randomized, controlled, double-blind, 3-arm parallel study was to determine the effectiveness of a prophylaxis paste containing 15% calcium sodium phosphosilicate (CSPS; NovaMin(®) ) with and without fluoride in reducing dentine hypersensitivity immediately after a single application and 28 days following dental scaling and root planing. MATERIALS & METHODS Overall, 151 subjects were enrolled in this study. All subjects received a scaling and root planing procedure followed by a final prophylaxis step using one of three different prophylaxis pastes: Test-A (15% NovaMin(®) and NaF), Test-B (15% NovaMin(®) ) and a control. Dentine hypersensitivity was assessed by tactile stimulus (Yeaple Probe(®) ) and by air blast (Schiff scale) at baseline, immediately after and 28 days after a prophylaxis procedure. One hundred and forty-nine subjects completed the study. RESULTS Subjects having received the test prophylaxis pastes showed statistically lower (anova, p
- Published
- 2013
- Full Text
- View/download PDF
35. Subgingival uptake and retention of stannous fluoride from dentifrice: Gingival crevicular fluid concentrations in sulci post-brushing.
- Author
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KLUKOVVSKA, MALGORZATA A., RAMJI, NIRANJAN, COMBS, CHELSEA, MILLEMAN, JEFFERY L., MILLEMAN, KIMBERLY R., RAMSEY, DAVID L., RATTANALDOMPOL, USA, HAVEN, CHRISTINA, MCCLENATHAN, DENISE, and WHITE, DONALD J.
- Subjects
DENTIFRICES ,GINGIVAL fluid ,TOOTHPASTE ,TOOTHBRUSHES ,ORAL hygiene products - Abstract
Purpose: To examine the delivery of stannous fluoride to subgingival sulci following toothpaste use in a clinical population. Methods: This was a controlled, single-site study. 23 subjects with at least 20 dental pockets, 2-4 mm with bleeding, who had not used a stannous fluoride dentifrice in the last 3 months were enrolled. After a 2-week washout period, 20 subjects returned for a baseline visit. They were instructed to refrain from brushing the night before the baseline visit. GCF samples were taken from up to 10 sites identified as sampling sites. Subjects were then given a 0.454% stannous fluoride dentifrice and soft manual toothbrush and asked to brush for 1 minute. 30 minutes after brushing, GCF was resampled. Subjects continued using the stannous fluoride dentifrice and soft manual toothbrush at home, twice daily for 2 weeks, in place of their usual hygiene products. At Days 1 and 14, subjects returned to the site, and 12 hours post-brushing GCF samples were taken. The samples were analyzed by 1CP-MS (inductively coupled plasma mass spectrometry). A Wilcoxon signed-rank test was performed to determine the difference between post-baseline visits and baseline. Statistical tests were 2-sided using a 5% significance level. Results: 20 subjects completed the trial. Significant levels of tin, a marker for stannous fluoride, were detected 30 minutes after brushing at sampling sites of 2-4 mm. The median tin level in gingival crevicular fluid (GCF) was 24.59 ng/pl, which was highly significant versus baseline (P< 0.0001). Tin levels sampled in GCF 12 hours after brushing on Days 1 and 14 were highly significant versus Baseline (P< 0.0001), showing an increasing trend with continued use. [ABSTRACT FROM AUTHOR]
- Published
- 2018
36. An exploratory study to investigate stain build-up with long term use of a stannous fluoride dentifrice.
- Author
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MILLEMAN, KIMBERLY R., PATIL, AVINASH, LING, MARTIN R., MASON, STEPHEN, and MILLEMAN, JEFFERY L.
- Subjects
DENTIFRICES ,DENTAL discoloration ,TIN compounds ,SODIUM tripolyphosphate ,DENTAL prophylaxis ,FLUORIDES - Abstract
Purpose: To monitor extrinsic stain formation over 24 weeks with twice-daily use of an anhydrous 0.454% SnF2 dentifrice containing 5% sodium tripolyphosphate (STP) ('Test'), compared to a standard fluoride dentifrice (0.76% fluoride as sodium monofluorophosphate [SMFP]) ('Comparator') following a professional prophylaxis. Methods: Primary efficacy variables were between-treatment differences in extrinsic dental stain of anterior teeth after 4, 8, 12, and 24 weeks' use using mean area and intensity scores of the MacPherson modification of the Lobene stain index (MLSI), and to monitor oral tolerability. Results: Overall, 214 subjects were randomized to treatment. The Test dentifrice group demonstrated statistically significantly less stain compared with the Comparator at each timepoint for all outcome variables (MLSI - Area x Intensity, Area only, and Intensity only) with the exception of MLSI (Area x Intensity) at Week 12. Products were generally well tolerated with 26 treatment-related adverse events (TRAEs) reported (10 with Test, 16 with Comparator). Five subjects withdrew from the 24-week study due to TRAEs, three in the Test group, two in the Comparator group. Statistically significantly less anterior tooth staining was observed with up to 24 weeks twice-daily brushing with a 0.454% SnF2/5% STP anhydrous dentifrice compared to a marketed fluoride dentifrice with 0.76% SMFP. [ABSTRACT FROM AUTHOR]
- Published
- 2018
37. An induced extrinsic tooth stain prevention model to investigate whitening potential of sugar-free chewing gums.
- Author
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DODDS, MICHAEL W. J., TIAN, MINMIN, RAMIREZ, LILIAN, MILLEMAN, JEFFERY L., MILLEMAN, KIMBERLY R., and PROSKIN, HOWARD M.
- Subjects
CHEWING gum ,TOOTH whitening ,DIGITAL image processing ,SPECTROPHOTOMETERS ,DENTAL discoloration - Abstract
Purpose: To establish an accelerated clinical test method to evaluate the effectiveness of sugar-free gums in prevention of the formation of extrinsic stains when chewed over a 2-week period in conjunction with daily tooth brushing. A secondary objective was to compare three methods for measuring extrinsic stain. Methods: 25 healthy adult volunteers were enrolled in a single center, examiner blind, randomized 4-way crossover clinical study. Starting with a stain-free baseline, subjects rinsed five times daily with freshly brewed black tea, followed either by chewing one of three different gums for 12 minutes or not chewing (negative control). Extrinsic stain was measured at 1 and 2 weeks by modified Lobene Stain Index (MLSI), digital imaging, and a Vita EasyShade spectrophotometer. Results: At 2 weeks, MLSI scores showed a statistically significant mean reduction of 43% or greater versus no-gum control for all three gum treatments. Digital image analysis and Vita EasyShade measurement showed reductions of yellowness (measured by difference in Ab* values between the three gums and the non-gum control treatment) ranging from 0.28 to 0.34 and 3.52 to 4.18 Ab* units, respectively, for subjects using the chewing gums versus no-gum control (P< 0.05) after 2 weeks. This clinical study demonstrated that sugar-free gum can effectively reduce new stain formation along with daily tooth brushing in as little as 2 weeks when used in conjunction with tea rinsing to help promote more rapid stain formation. All three test methods confirmed the results, albeit with different levels of statistical significance. A minor modification of gum base polymer, or change of flavors, did not significantly impact the prevention of new stain formation. [ABSTRACT FROM AUTHOR]
- Published
- 2017
38. A randomized clinical study to evaluate the effect of an ultra-low abrasivity dentifrice on extrinsic dental stain.
- Author
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YOUNG, SARAH, MASON, STEPHEN, MILLEMAN, JEFFERY L., and MILLEMAN, KIMBERLY R.
- Subjects
SODIUM tripolyphosphate ,SODIUM phosphates ,CLINICAL trials ,DENTIFRICES ,ORAL hygiene products - Abstract
Purpose: To investigate the stain-removal efficacy of an experimental ultra-low abrasivity anti-sensitivity dentifrice containing sodium tripolyphosphate (STP) and a cocamidopropyl betaine/sodium methyl cocoyl taurate detergent system. Methods: This was a single-center, examiner-blind, randomized, parallel-group study. Extrinsic dental stain was assessed on the facial surfaces of the six maxillary and six mandibular anterior teeth and the lingual surfaces of the six mandibular anterior teeth using the Macpherson modification of the Lobene Stain Index (MLSI). Treatments were: ultralow abrasivity dentifrice [5% w/w KNO
3 , 5% w/w STP, 1,100 ppm fluoride as sodium fluoride; relative dentin abrasivity (RDA) ~10; n=54]; moderate abrasivity fluoride dentifrice (1,100 ppm fluoride as sodium monofluorophosphate; RDA -68; n= 57); higher abrasivity daily-use whitening dentifrice (1,100 ppm fluoride as sodium fluoride; RDA -137; n= 57). Subjects brushed for 1 minute, twice daily, for 8 weeks. Results: Mean total MLSI [Area × Intensity (A × l)] change from baseline score at Weeks 4 and 8 was significant (P< 0.0001) for all groups. At Week 8, for the ultra-low abrasivity dentifrice versus the moderate and higher abrasivity dentifrices, mean total MLSI (A × l) scores (P< 0.0001), along with MLSI endpoints in facial, lingual, and interproximal regions (P= 0.0035 to P< 0.0001), favored the ultra-low abrasivity dentifrice. Dentifrices were generally well-tolerated. The ultra-low abrasivity dentifrice containing 5% STP reduced extrinsic dental stain more effectively than moderate or higher abrasivity dentifrices. [ABSTRACT FROM AUTHOR]- Published
- 2017
39. Subjective Assessment of Enamelon® Preventive Treatment Gel in a Self-Reported Dry-Mouth Population.
- Author
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Milleman, Jeffery L, Milleman, Kimberly R, Santos, Sylvia L, Proskin, Howard M, Battershell, Kirstin K, and DiMarino, James C
- Subjects
DENTIFRICES ,DENTAL fluoride treatment ,PHOSPHATES ,OXIDOREDUCTASES ,GLYCOSIDASES ,PHARMACEUTICAL gels ,COMBINATION drug therapy ,COMPARATIVE studies ,CROSSOVER trials ,RESEARCH methodology ,MEDICAL cooperation ,RESEARCH ,STATISTICAL sampling ,SELF-evaluation ,EVALUATION research ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,BLIND experiment ,XEROSTOMIA ,THERAPEUTICS - Abstract
Background: The efficacy of stannous fluoride toothpastes is well established for reducing caries, plaque, and gingivitis and relieving the discomfort of dentin hypersensitivity. Management of dry mouth may include relief remedies in addition to usual oral hygiene methods to maintain oral health and improve quality of life. This 6-week, single-blind, randomized, two-period crossover clinical study was designed to evaluate the oral tolerance and potential of Enamelon® Preventive Treatment Gel (EPTG), with 0.4% stannous fluoride, to relieve subject-perceived dry-mouth symptoms in a self-reported dry-mouth population, after 14 days of use, compared to a marketed over-the-counter (OTC) artificial saliva gel product (Biotene® Oral Balance Gel [BOBG]).Methods: Following a 7-day washout period, 52 qualified subjects with self-reported dry-mouth symptoms received EPTG or BOBG for once-daily use for 14 days. All subjects brushed each morning and evening with a standard fluoride toothpaste (Sensodyne® ProNamel). Each evening and following brushing with the Sensodyne ProNamel, subjects used their assigned gel product (EPTG or BOBG) as directed. On Days 1, 8, and 15, subjects received an oral examination and assessed relief of dry-mouth symptoms using a product-performance questionnaire (PPQ). Procedures were repeated with the alternate product for another 14-day period, following a 7-day washout. Data for each efficacy endpoint were analyzed using crossover ANOVA model.Results: No treatment-related adverse events were reported in this study, and both products were well tolerated by the subjects. Compared to pre-study ratings of usual dry-mouth remedies, both BOBG and EPTG significantly reduced dry-mouth symptoms following 14 days of use. BOBG was statistically significantly better than EPTG in relieving many of the principal dry-mouth symptoms such as providing immediate relief, having an immediate moisturizing and immediate lubricating effect, feeling comfortable in the mouth, soothing the mouth, effectively lubricating the mouth, and protecting the mouth from drying out (P < .05). Compared with subjects' ratings of their usual dry-mouth remedies, EPTG also provided relief of several dry-mouth symptoms at both Days 8 and 15 (P < .05).Conclusion: Based on subjective measures of dry mouth and compared with pre-study ratings of usual remedies, subjects perceived that EPTG helped to manage symptoms such as relieving the discomfort of dry mouth, immediately moisturizing and lubricating, effectively lubricating, protecting from drying out, and providing long-lasting moisturization and long-lasting lubrication, and was not irritating to dry-mouth tissues. BOBG, the positive control, was significantly better than EPTG in relieving dry-mouth symptoms over a 2-week period and was not irritating.Practical Implications: Patients with dry-mouth symptoms may benefit from daily use of a non-irritating, OTC fluoride preventive treatment gel product to relieve symptoms while also reducing the risks of developing dental caries, demineralization, dentin hypersensitivity, and gingivitis. [ABSTRACT FROM AUTHOR]- Published
- 2016
40. Efficacy of an experimental toothpaste containing 5 % calcium sodium phosphosilicate in the relief of dentin hypersensitivity: An 8-week randomized study (Study 2).
- Author
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SUFI, FARZANA, HALL, CLAIRE, MASON, STEPHEN, SHAW, DAVID, MILLEMAN, JEFFERY, and MILLEMAN, KIMBERLY
- Subjects
TOOTHPASTE ,DENTIFRICES ,TOOTH sensitivity ,DENTIN ,TREATMENT effectiveness ,DENTINAL tubules ,THERAPEUTICS - Abstract
Purpose: To compare the efficacy of an experimental toothpaste containing 5% (w/w) calcium sodium phosphosilicate (CSPS) in relieving dentin hypersensitivity (DH) with that of control toothpastes containing no known anti-sensitivity ingredients. Methods: This was the second of two exploratory, randomized, four-treatment, examiner-blind, parallel-design, single-site, 8-week studies in healthy subjects with self-reported and clinically diagnosed DH. After an initial lead-in period, subjects were randomized to one of four study treatments: the experimental toothpaste containing 5% CSPS with a modified surfactant system, developed to enhance its organoleptic properties; an abrasivity-matched placebo formulation (0% CSPS) with additional abrasive silica replacing the CSPS; or one of two commercially available fluoride toothpastes as controls. Subjects were instructed to brush twice daily for the next 8 weeks. DH was assessed at baseline and following 4 and 8 weeks of treatment by response to tactile and evaporative (air) stimuli, and using a Dentine Hypersensitivity Experience Questionnaire (DHEQ; a validated quality of life measure for DH). Results: A total of 137 subjects were included in the efficacy analysis. The experimental 5% CSPS toothpaste demonstrated statistically significant reductions from baseline in sensitivity at Week 4 and Week 8 for each clinical measure (all P< 0.01). It also demonstrated significantly greater improvements in DH compared with the two control toothpastes for the majority of clinical measures at Week 4 (P< 0.01) and for all clinical measures at Week 8 (all P < 0.01). The abrasivity-matched 0% CSPS toothpaste was associated with similar outcomes to the 5% CSPS toothpaste. The DHEQ responses did not reveal any consistent statistically significant within-treatment changes from baseline or between-treatment differences. Strong correlations with DHEQ outcomes were only observed for the subjects' sensitivity rating in response to evaporative (air) stimuli at Week 8. Study treatments were well tolerated. [ABSTRACT FROM AUTHOR]
- Published
- 2016
41. Confirmation of efficacy in providing relief from the pain of dentin hypersensitivity of an anhydrous dentifrice containing 0.454% with or without stannous fluoride in an 8-week randomized clinical trial.
- Author
-
PARKINSON, CHARLES R., JEFFERY, PETER, MILLEMAN, JEFFERY L., MILLEMAN, KIMBERLY R., and MASON, STEPHEN
- Subjects
ANALGESIA ,DENTIN abnormalities ,DENTIFRICES ,RANDOMIZED controlled trials ,TIN compounds ,THERAPEUTICS - Abstract
Purpose: To compare the efficacy of an anhydrous dentifrice containing 0.454% w/w stannous fluoride and a negative control dentifrice containing 1,000 ppm fluoride, as sodium monofluorophosphate, at reducing dentin hypersensitivity over 8 weeks with twice-daily brushing. Methods: This was a randomized, examiner-blind, parallel, two treatment group, stratified (by maximum baseline Schiff sensitivity score), 8-week clinical study carried out at a single site in 119 healthy subjects with at least two sensitive teeth, who met all study criteria at the screening and baseline visits. Clinical assessments of sensitivity to evaporative (air) [with Schiff sensitivity score and visual analogue scale (VAS)] and tactile (Yeaple probe) stimuli were employed to compare the efficacy of the test dentifrice containing 0.454% w/w stannous fluoride to the negative control dentifrice at reducing sensitivity after 4 and 8 weeks treatment. Results: Of the 119 subjects randomized to study treatment, 113 completed the study. At 4 and 8 weeks, between treatment analyses found the test dentifrice to be significantly better than the negative control dentifrice in relieving dentin hypersensitivity for all measures (Schiff: P< 0.0001 at 4 and 8 weeks; VAS score: P= 0.0003 at 4 weeks, P< 0.0001 at 8 weeks; tactile threshold: P= 0.0138 at 4 weeks, P< 0.0001 at 8 weeks). [ABSTRACT FROM AUTHOR]
- Published
- 2015
42. Plaque reduction efficacy of an oscillating-rotating power brush with a novel brush head utilizing angled bristle tufts.
- Author
-
Klukowska, Malgorzata, Grender, Julie M, Conde, Erinn, Milleman, Kimberly R, and Milleman, Jeffery L
- Abstract
Purpose: To evaluate an oscillating-rotating power brush with a novel brush head utilizing angled bristle tufts versus a manual brush for plaque removal.Methods: This was a single-center, randomized, open-label, examiner-blind, two-treatment, parallel-group study. Subjects brushed with their assigned toothbrush and a marketed dentifrice twice daily at home for 6 weeks. Plaque measurements were evaluated at baseline and week 6 using the Turesky Modified Quigley-Hein Plaque Index (TQHPI). Data was analyzed using the analysis of covariance (ANCOVA) with baseline as the covariate.Results: Ninety-four subjects completed the study, with 46 in the manual group and 48 in the power group. The oscillating-rotating brush with the novel brush head demonstrated statistically significantly greater reductions in whole mouth and interproximal plaque measures compared to the manual toothbrush. The benefit for the oscillating-rotating brush over the manual control brush was 164.5% for whole mouth plaque and 167.4% for interproximal plaque (P < 0.001) measured 12 hours after brushing. Both brushes produced statistically significant reductions in plaque measures relative to baseline (P < 0.001 for both measures). There were no adverse events reported or observed for either brush.Conclusions: The oscillating-rotating brush with the novel brush head produced reductions in whole mouth and interproximal plaque more than twice that of the manual toothbrush. [ABSTRACT FROM AUTHOR]- Published
- 2014
43. Digital plaque imaging evaluation of a stabilized stannous fluoride dentifrice compared with a triclosan/copolymer dentifrice.
- Author
-
TAO HE, BARKER, MATTHEW L., BIESBROCK, AARON R., EYNON, HOLLY, MILLEMAN, JEFFERY L., MLLLEMAN, KLMBERLY R., PUTT, MARK S., and WINTERGERST, ANA MARÍA
- Subjects
DENTAL plaque ,DENTIFRICES ,TRICLOSAN ,PHYSIOLOGICAL effects of fluorides ,COPOLYMERS ,TIN compounds ,PREVENTION - Abstract
Purpose: To compare the relative plaque control efficacy of a marketed 0.454% stabilized stannous fluoride (SnF
2 ) dentifrice relative to a triclosan/copolymer dentifrice using digital plaque imaging analysis (DPIA). Methods: This was a randomized, two-treatment, double-blind, parallel group design study that compared SnF2 and triclosan/copolymer dentifrices over a period of 3 weeks. DPIA was used to capture a digital image of the maxillary and mandibular anterior facial surfaces of 12 teeth and to calculate plaque area coverage. Overnight DPIA images were taken at a baseline visit after which subjects were randomly assigned to one of the two treatment groups and were required to brush with their assigned dentifrice according to each manufacturer's instructions. Subjects had DPIA assessments on two separate days at the end of Week 3. Results: 96 subjects were randomized to treatment. Plaque area data for 47 subjects per treatment group were compared at Week 3 using ANCOVA. The SnF2 group demonstrated a statistically significant reduction in overnight plaque at Week 3 compared to baseline (P= 0.002). The reduction for the triclosan group at Week 3 compared to baseline was not statistically significant (P= 0.24). At Week 3, the SnF2 group demonstrated a 17% lower adjusted mean for overnight plaque relative to the triclosan group with a mean difference that was statistically significant (P< 0.05). The Week 3 adjusted mean change from baseline in overnight plaque for the SnF2 group was 3 times greater versus that of the triclosan group (P< 0.05). [ABSTRACT FROM AUTHOR]- Published
- 2013
44. NUPRO Sensodyne prophylaxis paste with NovaMin for the treatment of dentin hypersensitivity: A 4-week clinical study.
- Author
-
MILLEMAN, JEFFERY L., MILLEMAN, KIMBERLY R., CLARK, COURTNEY E., MONGIELLO, KIMBERLY A., SIMONTON, THOMAS C., and PROSKIN, HOWARD M.
- Subjects
DENTAL prophylaxis ,DENTIN ,FLUORIDES ,SODIUM ions ,HYDROXYAPATITE - Abstract
Purpose: The primary objective of this study was to compare the effectiveness of NUPRO Sensodyne Prophylaxis Paste with NovaMin, with and without fluoride, to a standard prophylaxis paste without fluoride (control) in reducing dentin hypersensitivity immediately after a single application following dental scaling and root planing. The secondary objective was to compare the duration of sensitivity relief up to 28 days after a single application of the NUPRO pastes with NovaMin compared to the control paste. Methods: This was a randomized, single-center, controlled, three- treatment, parallel-group study conducted at Salus Research in Fort Wayne, Indiana. Male and female subjects who met all inclusion/exclusion criteria and had two non-adjacent sensitive teeth based on tactile (Yeaple probe) and air blast assessments, were enrolled in the study. At baseline, tactile and air blast stimuli were administered and subjects were stratified according to their baseline air blast (Schiff) scores into one of three treatment groups: Group A (NovaMin without fluoride), Group B (NovaMin with fluoride) or Group C (NUPRO classic prophylaxis paste without fluoride). Subjects were then assessed post-treatment and at a 28-day follow-up using tactile and air blast methods. Results: A total of 139 patients completed the study. Subjects having received the NovaMin containing prophylaxis pastes (Groups A and B) showed statistically lower (ANOVA, P< 0.05) dentin hypersensitivity compared to the control group immediately after the prophylaxis procedure. Group A tactile improvements were 86% immediate, and 88% after 28 days; air blast improvements were 49% immediate, and 50% after 28 days. Group B tactile improvements were 67% immediate, and 65% after 28 days; air blast improvements were 43% immediate, and 34% after 28 days. Group C experienced little improvement in tactile and air blast scores, 9% and 4% respectively, immediately following treatment, and 10% and 1% respectively after 28 days. At both time points, the reduction in sensitivity was meaningful and significantly better than in the group receiving a standard prophylaxis paste as the comparator (P< 0.05). Both NovaMin pastes were effective and there was no statistical difference between the pastes with and without fluoride. There were no adverse events reported during the course of this study. [ABSTRACT FROM AUTHOR]
- Published
- 2012
45. A RANDOMIZED CROSSOVER-DESIGN STUDY TO INVESTIGATE THE PLAQUE REMOVAL EFFICACY OF TWO POWER TOOTHBRUSHES: PHILIPS SONICARE FLEXCARE AND ORAL-B TRIUMPH.
- Author
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Putt, Mark S., Milleman, Jeffery L., Jenkins, Wendy, Schmitt, Paul, Master, Aditi S., and Strate, Joerg
- Subjects
RANDOMIZED controlled trials ,ORAL hygiene ,DENTAL plaque ,TOOTHBRUSHES ,CLINICAL trials ,DENTAL research ,THERAPEUTICS - Abstract
The Sonicare® FlexCare and the Oral-B® Triumph® Professional Care® 9000 power toothbrushes were compared in a single-use, examiner-masked, crossover clinical trial. Outcomes were evaluated using the Turesky Modified Quigley-Hein (TMQH) plaque index. Percent reduction in overall plaque score because of toothbrushing was the primary efficacy measure. Subjects were required to have a TMQH score ⩾ 1.8 at screening after refraining from oral hygiene for 24 hours. The study included three visits. At visit 1, subjects were randomized to one of two treatment sequences, given their first toothbrush and toothpaste, and instructed to use them twice daily for 2 minutes during a 1-week familiarization phase. Before visit 2, subjects again refrained from oral hygiene for 24 hours. At this visit, plaque scores were assessed before and after a 2-minute supervised brushing episode, then the second test product was issued. Familiarization, plaque accumulation, and clinical examinations were the same for both product use periods. Data were analyzed using a linear mixed effects model with subject as a grouping factor. Treatment effects were expressed as mean values and the appropriate 95% confidence intervals (Cl). Ninety-six subjects were screened with 93 subjects completing the study. The sample's TMQH score at Visit 1 was 3.18 ± 0.42 (mean ± standard deviation [SD]). Full-mouth prebrushing plaque scores were 2.85 ± 0.49 for FlexCare and 2.94 ± 0.45 for Triumph. Respective full-mouth reductions in overall plaque score were 38.02% ± 15.14% and 30.43% ± 14.05%. The estimated treatment effect, expressed as difference between FlexCare and Triumph in percent plaque index reduction, was 7.59% with a 95% Cl from 4.79% to 10.40%. Similar differences were observed for all subregions, including anterior, posterior, interproximal, and interproximal posterior sites. The same protocol design was used at an earlier study in another center. The combined overall treatment effect from the two studies was estimated at 6.97% (95% Cl: 5.17%, 8.78%), favoring FlexCare. [ABSTRACT FROM AUTHOR]
- Published
- 2008
46. A 3-month clinical comparison of the safety and efficacy of two battery-operated toothbrushes: The Braun Oral-B Battery Toothbrush and the Colgate Actibrush.
- Author
-
PUTT, MARK S., MILLEMAN, JEFFERY L., DAVIDSON, KIMBERLY R., CUGINI, MARY ANN, and WARREN, PAUL R.
- Subjects
TOOTHBRUSHES ,GINGIVAL diseases ,DENTAL plaque ,TOOTH care & hygiene ,GINGIVITIS - Abstract
Purpose: To compare the safety and efficacy of two battery-operated, non-rechargeable power toothbrushes, the Braun Oral-B Battery toothbrushes (D4) and the Colgate Actibrush. Materials and Methods: This was a randomized, single-blind, parallel-group study carried out over a 3-month period. A total of 114 subjects from a general population, who met the inclusion criteria of the study and who had whole mouth plaque scores of ≥ 1.5 and gingivitis scores of ≥ 1.2, participated in the study. Subjects were given either the D4 or the Colgate Actibrush with the manufacturers' instructions, and were asked to brush their teeth at home twice each day. At baseline and after 1 and 3 months, subjects were examined for oral hard and soft tissue health, after which they were assessed for gingivitis (Modified Gingival Index), bleeding (Gingival Bleeding Index), and plaque (Modified Quigley-Hein Plaque Index). Prior to each assessment, subjects refrained from all oral hygiene procedures for a period of 12-18 hours. Results: No evidence was found of significant oral soft or hard tissue trauma, and both brushes were considered to be safe when used according to the manufacturers' instructions. In the D4 group, whole mouth, marginal and approximal plaque scores were significantly reduced from baseline (P< 0.05) after both 1 and 3 months by 7-12%, whereas, in the Actibrush group, plaque scores remained relatively unchanged from baseline throughout the study. Furthermore, comparisons between the toothbrush groups showed that whole mouth, marginal and approximal plaque scores for the D4 were significantly lower than those for the Actibrush at both the 1- and 3-month assessments. Modified Gingival Index scores after 3 months were significantly reduced from baseline in both groups by 7-8%. Similarly, percentages of bleeding sites were significantly lower by 12-15%. There were no significant differences between the groups with respect to gingivitis scores. [ABSTRACT FROM AUTHOR]
- Published
- 2001
47. A Randomized, Parallel Design Study to Evaluate the Effects of Different Oral Cleaning Modalities on Gingivitis and Plaque After a 6-Week Period of Home Use.
- Author
-
Li J, Mirza F, Wang PW, Argosino K, Milleman K, Milleman J, and Ward M
- Subjects
- Humans, Middle Aged, Adult, Male, Female, Aged, Adolescent, Single-Blind Method, Oral Hygiene, Young Adult, Dental Plaque Index, Gingivitis prevention & control, Dental Plaque prevention & control, Dental Devices, Home Care, Toothbrushing instrumentation, Periodontal Index
- Abstract
The study objective was to evaluate the effect of different interdental oral cleaning modalities on gingivitis and plaque following a 6-week period of home use. This was a randomized, parallel, examiner-blinded study. Study subjects were routine manual toothbrush (MTB) users with moderate to severe gingivitis, aged 18 to 65 years. Subjects were required to have a gingival bleeding score of ≥1 on at least 50 gingival sites per the Gingival Bleeding Index (GBI) and to have a minimum average plaque score of ≥0.6 per the Rustogi Modified Navy Plaque Index (RMNPI) following a 3- to 6-hour plaque accumulation period. Subjects were randomly assigned to one of four groups based on the oral care cleaning modality: (1) NON group: MTB alone, (2) FLS group: MTB plus string floss, (3) MPF group: MTB plus a Philips® Sonicare® Power Flosser with the Quad Stream nozzle, or (4) PPF group: Philips Sonicare power toothbrush plus the power flosser. Safety and efficacy measures (Modified Gingival Index [MGI], GBI, and RMNPI) were assessed at baseline, 2 weeks, and 6 weeks. The primary efficacy endpoint was the reduction in gingival inflammation from baseline to week 6 as measured by the MGI. A total of 260 subjects were randomized and 256 subjects completed the study. The adjusted mean percent reduction in gingival inflammation from baseline to week 6 was 14.90% for the NON group, 13.16% for the FLS group, 33.51% for the MPF group, and 49.30% for the PPF group. Pairwise comparisons indicated that both the PPF and MPF groups were statistically significantly different from both the NON and FLS groups. In conclusion, use of either the Philips Sonicare power toothbrush with the Philips Sonicare Power Flosser or an MTB with the Philips Sonicare Power Flosser was statistically superior to an MTB alone and an MTB used with string floss in reducing gingival inflammation following 6 weeks of home use.
- Published
- 2024
48. Clinical Assessment of Plaque Removal Using a Novel Dentifrice Containing Cellulose Microfibrils.
- Author
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Labib ME, Perazzo A, Manganaro J, Tabani Y, Milleman KR, Milleman JL, and Walsh LJ
- Abstract
Dentifrice performance in the removal of dental plaque is influenced by the interactions of dentifrice components with tooth surfaces. This randomized controlled clinical study assessed the effectiveness and safety of a novel fluoride dentifrice formulation that included a micro-fibrillated cellulose network with entangled microcrystalline cellulose and silica particles (Protegera
TM ), and compared this to a positive control fluoride dentifrice (Crest Cavity Protection™). Whole mouth dental plaque levels in 82 healthy adults were measured after the first supervised use, and following a week of twice daily use at home. Overall, the test dentifrice was at least three times and up to four times more effective in whole-mouth plaque reductions, with a 38.6% reduction on first use, a 30.9% reduction at day 7, and a 41.6% reduction from day 1 to day 7, compared to reductions of 12.0%, 9.6% and 11.6%, respectively for the positive control, and up to seven times more effective in lingual plaque reductions, than the reference dentifrice ( p < 0.001), with a 27.7% reduction on first use, a 22.3% reduction at day 7, and a 31.0% reduction from day 1 to day 7, compared to reductions of 4.4%, 2.2%, and 4.5%, respectively, for the positive control. No safety issues arose from the use of the test dentifrice. These results indicate that including micro-fibrillated cellulose enhances plaque removal effectiveness, without causing adverse changes to oral soft tissues.- Published
- 2023
- Full Text
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49. Clinical Efficacy of the Oral Health System by Fresh Health Inc. in Adults on Gingivitis and Plaque in a 3-Arm, 30-Day Study as Compared to String Floss and Manual Brushing.
- Author
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Milleman KR, Milleman JL, Gaff M, Cook K, and Mateo L
- Subjects
- Humans, Adult, Female, Male, Middle Aged, Single-Blind Method, Periodontal Index, Dental Plaque Index, Dentifrices therapeutic use, Young Adult, Treatment Outcome, Gingivitis prevention & control, Toothbrushing instrumentation, Dental Plaque prevention & control, Dental Devices, Home Care
- Abstract
Objective: To evaluate the safety and efficacy of the Oral Health System by Fresh Health Inc., used in conjunction with manual toothbrushing (Fresh + MTB) as compared to string floss and manual toothbrushing (floss + MTB) and manual toothbrushing (MTB) alone, as measured by clinical signs of gingivitis, plaque reduction, pocket depth, and bleeding., Methods: One hundred ninety-two (192) generally healthy adults exhibiting signs of gingivitis completed this 30-day randomized, controlled, examiner-blinded, three-group parallel study design. All subjects were assigned a manual toothbrush and fluoride dentifrice, instructed to brush twice daily according to their normal habits, and provided with written and verbal instructions for all assigned products. Subjects in the control group used only the manual toothbrush and dentifrice. Subjects assigned to the string floss + MTB group were instructed to also floss once daily. Subjects assigned to the Fresh + MTB group were provided a Fresh Health Inc. custom-fit oral irrigator and instructed to use the device once daily with water for approximately 7 seconds in addition to toothbrushing. Gingivitis was assessed using the modified gingival index (MGI), bleeding on marginal probing was assessed via the gingival bleeding index (GBI), and plaque was measured using the Rustogi modified navy plaque index (RMNPI) at day 1, day 15, and day 30. Periodontal probing depth (PPD) and bleeding on probing (BOP) were measured at day 1 and day 30. Oral soft- and hard-tissue assessments were performed at all examination visits., Results: There was no significant difference in age or sex between groups, and no significant difference in baseline MGI, GBI, RMNPI, BOP, and PPD values across groups. The Fresh + MTB group demonstrated statistically significantly better performance than the floss + MTB group and MTB group across all clinical indices at both 15 days and 30 days. At 30 days, the Fresh + MTB group showed a 40.9% improvement in whole-mouth MGI, which was significantly greater than the MTB and floss + MTB groups.
- Published
- 2023
50. A Randomized Parallel Study to Compare the Effects of Powered and Manual Tooth Brushing on Gingival Health and Plaque.
- Author
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Starke EM, Ward M, Olson M, Ou SS, Milleman KR, and Milleman JL
- Subjects
- Adolescent, Adult, Aged, Dental Plaque Index, Equipment Design, Humans, Middle Aged, Periodontal Index, Single-Blind Method, Young Adult, Dental Plaque therapy, Gingivitis therapy, Toothbrushing instrumentation
- Abstract
Objectives: To compare the effect of powered and manual tooth brushing on plaque and gingivitis following two and six weeks of home use., Methods: This was a randomized, three-arm, parallel-design clinical trial. Eligible participants were manual toothbrush users who were generally healthy non-smokers, aged 18-65 years, with a plaque score of = 1.8 per Lobene and Soparkar Modified Plaque Index (MPI), and mild to moderate gingivitis, defined as a Gingival Bleeding Index (GBI) = 1 on at least 20 sites. Subjects with advanced periodontal disease, excessive gingival recession, and heavy deposits of calculus or rampant decay were excluded. Enrolled participants were randomly dispensed one of three devices: a powered toothbrush (Philips Sonicare DiamondClean Smart with Premium Gum Care brush head) used in either Gum Heath mode (DC-GH) or Clean mode (DC-C), or an ADA reference manual toothbrush (MTB). Efficacy and safety variables were assessed at Baseline, and at two and six weeks following twice-daily product home use., Results: For the primary endpoint, reduction in gingivitis per Modified Gingival Index (MGI) at Week 2, 188 subjects completed and were included in the analysis. Expressed as percent reduction from Baseline, the adjusted mean reduction and Standard Error (SE) estimates were 60.31% (1.95%) for DC-GH, 53.08% (1.95%) for DC-C, and 16.59% (1.96%) for MTB. The difference between each power toothbrush group and the manual toothbrush was statistically significant (p < 0.0001). Statistically significant differences were also observed between DC-GH, DC-C, and manual tooth brushing for MGI at Week 6, as well as for MPI and GBI at Weeks 2 and 6., Conclusions: The powered toothbrush, used in either Gum Health or Clean mode, was statistically significantly superior to a manual tooth brush in reducing gingival inflammation, gingival bleeding, and plaque following two and six weeks of home use., Competing Interests: E.M. Starke, M. Ward, M. Olson, and S-S Ou are employed by Philips Oral Healthcare. K. Milleman and J. Milleman are employed by Salus Research., (Copyright© by the YES Group, Inc.)
- Published
- 2019
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