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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]

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]

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]

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]

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 (ProtegeraTM), 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]

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]

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]

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]

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]

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]

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]

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]

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]

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 KNO3, 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]

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]

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]

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]

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]

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]

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.

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.

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.

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.)

Objectives: The objective of this study was to compare the effect of two home use oral hygiene regimens on plaque, gingivitis, and gingival bleeding on subjects undergoing orthodontic treatment with fixed appliances., Methods: This was a randomized, parallel, single-center clinical trial. Eligible study subjects fit the following profile: age 12-65 years; nonsmoker; plaque score of = 2.0 per Bonded Bracket Index (BBI) on dentition with fixed orthodontic hardware; minimum of 10 orthodontic brackets in each arch or on all teeth from first molar to first molar; presenting with mild to moderate gingivitis, defined as a score of = 1 on at least 20 sites per Gingival Bleeding Index (GBI). Subjects with advanced periodontal disease or gingival recession were not eligible. Eligible subjects were randomized to one of two home use oral hygiene regimens: manual toothbrush plus string floss (used with a threading device) for interdental cleaning (MTF regimen); or Philips Sonicare EasyClean power toothbrush with InterCare brush head and AirFloss Pro powered device, used with BreathRx mouthrinse for interdental cleaning (Sonicare Orthodontic Regimen or SOR). All subjects brushed twice daily with standard fluoridated dentifrice and performed interdental cleaning once daily. Efficacy and safety examinations were performed at Baseline and following three and six weeks of home use of the study products, and included assessments of BBI, GBI, Modified Gingival Index (MGI), and Modified Plaque Index (MPI)., Results: Of 228 enrolled subjects, 223 were included in the primary analysis. For the primary endpoint, reduction in BBI score following three weeks of product use, the overall least squares (LS) mean (95% CI) reduction was 0.89 (0.84, 0.95) for SOR and 0.06 (0.01, 0.12) for MTF. Expressed as percent reduction (95% CI) from Baseline, this was 33.1% (31.1%, 35.2%) for SOR and 2.01% (-0.06%, 4.07%) for MTF. The differences between regimens were statistically significant, p < 0.0001. Statistically significant differences between regimens were observed in BBI following six weeks of product use, and also for all other efficacy variables (GBI, MGI, MPI) at Week 3 and Week 6., Conclusions: The powered oral hygiene regimen was significantly more effective than a manual regimen in reducing plaque on bracketed and non-bracketed teeth, and in reducing gingival bleeding and gingival inflammation in orthodontic subjects following three weeks of use and persisting following six weeks of use. All products were safe on oral tissues and fixed orthodontic appliances., Competing Interests: K. Nammi, E.M. Starke, S-S Ou, M. Ward, and W. Jenkins are employed by Philips Oral Healthcare. J. Milleman and K. Milleman are employed by Salus Research., (Copyright© by the YES Group, Inc.)

Objectives: To compare the effect of a powered and a manual toothbrush on gingivitis and plaque following two and four weeks of home use., Methods: This was a randomized, parallel-design, single-blind clinical trial. Eligible participants were generally healthy non-smoking manual toothbrush users aged 18-65 years, with a plaque score of = 1.8 per Lobene and Soparkar Modified Plaque Index (MPI) following a 3-6 hour plaque accumulation period, and mild to moderate gingivitis defined as a Gingival Bleeding Index (GBI) = 1 on at least 20 sites. Subjects with advanced periodontal disease, xerostomia, excessive gingival recession, uncontrolled diabetes, and heavy deposits of calculus or rampant decay were excluded. Enrolled participants were randomly dispensed either a Philips Sonicare powered toothbrush used with the InterCare brush head (PTB) or an American Dental Association (ADA) reference manual toothbrush (MTB). Efficacy and safety variables were assessed at Baseline, and at two and four weeks following twice-daily product home use. The primary endpoint of the study was reduction of gingivitis per the Modified Gingival Index (MGI) after four weeks of home use., Results: All 148 randomized subjects (74 per group) completed the study. A statistically significant difference in MGI reduction was observed between the two study groups (p < 0.001). The least square (LS) mean and standard error reduction from Baseline was 0.72 (0.04) for the PTB group compared to 0.09 (0.04) for the MTB group. Expressed as percent reduction from Baseline, the LS mean values were 35.77% (2.19%) and 4.22% (2.19%) for PTB and MTB, respectively. Statistically significant differences were also observed for MGI reduction at Week 2, as well as for MPI and GBI reduction at Weeks 2 and 4., Conclusions: The powered toothbrush was statistically significantly superior to a manual toothbrush in reducing gingival inflammation, gingival bleeding, and plaque following two and four weeks of home use., Competing Interests: E.M. Starke, A. Mwatha, M. Ward, K. Argosino, and W. Jenkins are employed by Philips Oral Healthcare. J. Milleman and K. Milleman are employed by Salus Research., (Copyright© by the YES Group, Inc.)

Objectives: To compare the effect of the Philips Sonicare DiamondClean Smart and Oral-B Genius 8000 powered toothbrushes on gingivitis, gingival bleeding, and supragingival plaque reduction following 42 days of home use., Methods: This was a randomized, parallel, examiner-blinded, prospective clinical trial with two treatment groups. Eligible participants were generally healthy volunteers who were manual toothbrush users, non-flossers, 18-65 years of age. The subject panel included non-smokers with = 50 sites of gingival bleeding according to the Gingival Bleeding Index (GBI), and a supragingival plaque score of = 1.8 per Modified Plaque Index (MPI) at 3-6 hours following last tooth brushing encounter. Eligible subjects were randomized to use either a Philips Sonicare DiamondClean Smart with Premium Plaque Control brush head (DCS) or an Oral-B Genius 8000 with FlossAction brush head (OBG) for home use. Each toothbrush was used twice daily for two minutes. All subjects used a standardized fluoride-containing dentifrice. All other oral hygiene measures were prohibited. Subjects returned at Day 14 for an interim compliance and safety assessment, and at Day 42 for the final safety and efficacy assessments., Results: Of 222 enrolled and eligible subjects, 219 completed (112 in the SDC group, 107 in the OBG group) the study. The least squares (LS) mean and 95% confidence interval (CI) estimates for gingivitis reduction and percent reduction per Modified Gingival Index (MGI) following 42 days of product home use were 1.38 (1.30, 1.46) and 51.32% (48.45%, 54.19%) for DCS, and 0.53 (0.45, 0.61) and 20.07% (17.14%, 23.00%) for OBG. The differences, expressed as either reduction or percent reduction, were statistically significant between the two groups, p < 0.001. Statistically significant differences were also observed between products at Day 42 for the gingival bleeding and supragingival plaque reduction endpoints, p < 0.001. There were two reported adverse events., Conclusions: The Philips Sonicare DiamondClean Smart powered toothbrush reduced gingival inflammation, gingival bleeding, and supragingival plaque significantly more than the Oral-B Genius 8000 powered toothbrush following a 42-day home-use period. Both products were safe for use., Competing Interests: F. Mirza, K. Argosino, M. Ward, and San-San Ou are employed by Philips Oral Healthcare. K. Milleman and J. Milleman are employed by Salus Research, (Copyright© by the YES Group, Inc.)