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OBJECTIVE: To review the available literature pertaining to amantadine as therapy for improving cognition and reducing agitation following a non-penetrating traumatic brain injury (TBI). DATA SOURCES: Clinical literature was accessed through MEDLINE (from 1966 to February 2004) and bibliographic searches. Key search terms included 'amantadine', 'traumatic brain injury', 'cognition', and 'agitation'. DATA SYNTHESIS: Amantadine is primarily used for treatment and prophylaxis of influenza A. Its ability to improve mentation and motor function in patients with head injury remains questionable. An evaluation of five clinical trials, two case reports, and one case series is conducted focusing on the use of amantadine following TBI. Patients in clinical trials were assessed using a variety of neuropsychological tools aimed at, among other things, assessing cognition and agitation. Although individual patient results varied, the majority of patients studied showed improved neuropsychological test scores. Similar observations are noted in the case reports and case series. Improvement in cognition and reduced agitation seems to occur with post-injury amantadine therapy. CONCLUSIONS: Amantadine is a reasonable option for improving cognition and reducing agitation following a TBI but confirmatory evidence of the efficacy the drug is necessary. [ABSTRACT FROM AUTHOR]

Background: During pregnancy, dental plaque-induced gingivitis prevalence and subsequent risk of periodontal disease increases substantially, as a consequence of both inadequate oral hygiene and changes in sex steroid hormone levels. Although maternal periodontal disease has been associated with adverse pregnancy outcomes, including spontaneous preterm birth, previous clinical trials involving mechanical debridement (eg, scaling and root planing) to remove plaque biofilm have not yielded decreased rates of preterm birth., Objective: We hypothesized that an advanced oral hygiene program, including an antibacterial regimen coupled with a power toothbrush and hygiene instruction, may improve the periodontal milieu and reduce the rate of spontaneous preterm birth. Therefore, we conducted a clinical trial of obstetrical patients with moderate-to-severe gingivitis who were randomized to an advanced oral hygiene program vs usual oral hygiene care, and the primary obstetrical outcome compared between the treatment groups was gestational age at delivery., Study Design: Obstetrical patients with singleton pregnancies between 8 and 24 weeks' gestation were screened by trained dentists at 2 clinical sites for moderate-to-severe gingivitis (>30 intraoral sites with gingival bleeding on probing). Eligible participants were randomized to an advanced oral hygiene regimen, including antibacterial mouth wash, dental floss, antibacterial toothpaste, a power toothbrush, and intensive oral hygiene education vs standard oral home care instructions and regimen. The primary obstetrical outcome assessed was gestational age at delivery. The overall primary (dental) outcomes were gingival index, bleeding sites, and pocket depth (reported elsewhere). Secondary obstetrical outcomes included birthweight and incidence of preterm birth at <37 weeks' gestation. Regression models were utilized and included factors such as treatment group, gestational age at enrollment, preterm birth history, and potential markers of health disparities (ie, education, employment status)., Results: A total of 817 obstetrical patients underwent dental screening at the 2 sites, 789 were identified with moderate-to-severe gingivitis, 746 were randomized, and birth outcomes were available for 613 of the study participants. The gestational age at delivery was 2 days earlier in the control group (P=.040), but the clinical significance of this finding was limited (39.13 vs 38.85 weeks). Overall rates of spontaneous preterm birth <37 weeks and <34 weeks were not statistically different between the 2 treatment groups (7.0% advanced oral hygiene regimen vs 10.3% controls, OR=1.63 (0.90-3.00), P=.11; and 2.3% vs 3.9%, OR=1.88 (0.71-4.98), P=.20, respectively). However, we observed lower rates of spontaneous preterm birth among unemployed participants with less favorable socioeconomic status (4.7% advanced oral hygiene regimen vs 16.0% controls, OR=4.04 (1.34-15.12), P=.01)., Conclusion: An advanced oral hygiene program may reduce the risk of spontaneous preterm birth among pregnant patients with moderate-to-severe gingivitis and health disparities. This is the same group that may be at highest risk of poor dental hygiene and preterm birth., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Research shows there is a significant increase in gingival inflammation during pregnancy. This study was conducted to determine if an oral health intervention (OHI), including oral hygiene education delivered by nurse-led staff and an advanced over-the-counter (OTC) oral home care regimen, improved gingival inflammation in pregnant women with moderate-to-severe gingivitis compared with a standard oral hygiene control group., Methods: This was a multicenter, randomized, controlled, single-masked, parallel group clinical trial conducted in obstetrics clinics of 2 medical centers. A total of 750 pregnant women between 8 and 24 weeks of pregnancy with at least 20 natural teeth and moderate-to-severe gingivitis (>30 intraoral bleeding sites) were enrolled. Participants were randomized to either the OHI group, which included oral hygiene instructions supplemented with an educational video and advanced OTC antibacterial/mechanical oral hygiene products, or the control group receiving oral hygiene instructions and standard products. Both groups received oral hygiene instructions from nurse-led staff. Experienced, masked examiners measured whole mouth gingival index (GI) and periodontal probing depths (PDs) at baseline and months 1, 2, and 3., Results: Participants enrolled in this study presented with moderate-to-severe gingivitis at baseline. Both the OHI and control groups exhibited significant reductions in GI (P < .001) and PD (P < .03) from baseline that persisted throughout the study period. The OHI group exhibited modest, yet statistically greater, reductions in GI (P ≤ .044) compared with the control at all time points. The reduction in PD directionally favored the OHI group, but between-group differences were small (<0.03 mm) and not statistically significant (P > .18)., Discussion: Significant gingivitis was prevalent among participants in this study and identifies an opportunity to improve gingival health during pregnancy by providing oral health education during the course of prenatal care when coupled with an advanced OTC oral hygiene regimen., (© 2023 The Authors. Journal of Midwifery & Women's Health published by Wiley Periodicals LLC on behalf of American College of Nurse Midwives (ACNM).)

Background: Periodontal disease continues to be prevalent globally, but little clinical research has been undertaken to evaluate the long-term benefits of a daily oral hygiene regimen on progression of gingivitis/early periodontitis. The objective of this study was to evaluate the effects of an oral hygiene regimen (OHR) on the periodontal health of adults in good general health with established gingivitis and early periodontitis over 24 months., Methods: A randomized controlled trial was conducted in adults with established gingivitis, with isolated sites of probing pocket depth >4 mm. Study participants were randomized to the OHR (bioavailable stannous fluoride dentifrice, oscillating-rotating electric toothbrush, cetylpyridinium chloride rinse, and floss; P&G) or usual care products (sodium fluoride dentifrice and manual toothbrush; P&G) groups. At baseline and every 6 months, gingivitis and periodontal measures were assessed and a prophylaxis was conducted. The primary outcome was Gingival Bleeding Index-Bleeding Sites (GBI-BS). Analyses used ANCOVA at 5% significance levels., Results: A total of 107 individuals were enrolled; 87 completed the study. Mean GBI-BS, Modified Gingival Index, and Probing Pocket Depth (PPD) scores were significantly lower at each visit for the OHR versus usual care group by 28% to 39%, 12% to 18%, and 6% to 13%, respectively ( p ≤ 0.0009). The magnitude of reduction in median number of ≥2 mm PPD loss events for OHR versus the usual care group at 24 months was 74%., Conclusion: Long-term use of the OHR produced significant periodontal health improvements versus the usual care products., Competing Interests: This study was sponsored by The Procter & Gamble Company. HT, MLB, JMG, RWG, and ARB are employees of The Procter & Gamble Company. AZ and SM have been investigators for work sponsored by The Procter & Gamble Company., (Copyright ©2021 CDHA | ACHD.)

Purpose: To assess the hard tissue safety of a variety of low pH oral care rinses to dental enamel in a newly developed screening method., Methods: Bovine enamel specimens were subjected to a cycling model that consisted of commercial mouthrinse product exposures and artificial saliva soaks based on a previously published screening method. The effect of test products on the surface of treated specimens was measured using surface microhardness (SMH). Results are presented as the change in SMH (between sound enamel baseline and cycling final). An assortment of rinse products were assessed relative to distilled water (positive control) and 1% citric acid (negative control). A priori, a product was considered safe if the change in measured SMH values over the course of six treatment cycles was both significantly greater than the negative control and was not significantly different from the positive control. A non-inferiority statistical test was applied to create a quantitative rule defining product safety., Results: Products tested included two rinses with a pH in excess of 5.5, and eight with a pH less than 5.5. Four of the rinses included fluoride, while six did not. Analyses showed that all of the rinse products tested passed the non-inferiority acceptance criteria. One of the 10 marketed oral care rinses failed to meet the a priori criteria needed to be considered safe as the product was significantly better than the negative control but also significantly lower than the positive control treatment. This product had the lowest pH of all products tested and did not contain fluoride. Application of the non-inferiority statistical test showed the questionable product passing safety criteria. As a proposed method for a screening tool, further testing would be recommended based on these results., Clinical Significance: An in vitro enamel safety screening method was applied as an assessment of the enamel demineralization safety to a number of oral care rinse products. Surface microhardness, coupled with a non-inferiority statistical evaluation, provided a reasonable approach for detecting potential product issues. Products failing this screening laboratory method may require additional testing to verify their safety on hard tissues., Competing Interests: Dr. White is a Research Fellow Emeritus, Victor Mills Society, The Procter & Gamble Company. Dr. Chen was an employee of Procter & Gamble Company at the time the research was conducted. All other authors are employees of The Procter & Gamble Company., (Copyright©American Journal of Dentistry.)

Objective: To evaluate the efficacy of an oscillating-rotating (O-R) electric rechargeable toothbrush with a novel round brush head comprised of regular and tapered bristles in reducing plaque and gingivitis versus a manual toothbrush., Methods: This was a randomized, examiner-blind, parallel group, five-week study. Participants with mild-to-moderate plaque and gingivitis received an oral examination and were evaluated for baseline plaque (Rustogi Modified Navy Index), gingivitis (Modified Gingival Index) and gingival bleeding (Gingival Bleeding Index). Qualifying participants were randomly assigned to the novel Oral-B sensitive brush head (EB60) on an Oral-B Vitality O-R handle (D12) or an ADA manual toothbrush. Participants brushed twice daily with the assigned brush and a standard fluoride dentifrice for 5 weeks before returning for an oral examination and plaque and gingivitis evaluations., Results: A total of 150 participants were randomized to treatment and completed the study (mean age = 45.7 years). Both brushes demonstrated a statistically significant reduction in number of bleeding sites versus baseline (P < 0.001). At Week 5, the number of bleeding sites was reduced from baseline by 11.15 (52.2%) for the O-R brush and 5.04 (23.6%) for the manual brush. The treatment difference was statistically significant (P < 0.001). Significant reductions versus baseline (P < 0.001) were also seen for both brushes for MGI, GBI and Rustogi plaque measures (whole mouth, gingival margin and proximal), but the O-R brush produced significantly greater reductions versus the manual brush (P < 0.001)., Conclusion: The O-R handle and round brush head with tapered and regular bristles produced greater plaque and gingivitis reductions than the manual brush., (© 2018 The Authors. International Journal of Dental Hygiene Published by John Wiley & Sons Ltd.)

Objectives: To evaluate and compare the efficacy of a marketed oscillating-rotating electric rechargeable toothbrush to a marketed sonic toothbrush in the reduction of gingivitis and plaque over an 8-week period., Methods: This was a randomized, examiner-blind, parallel group, eight-week study. Subjects with presence of mild-to-moderate plaque and gingivitis received an oral examination and were evaluated for baseline gingivitis (Modified Gingival Index; MGI), gingival bleeding (Gingival Bleeding Index; GBI), and plaque (Rustogi Modified Navy Plaque Index). Qualified subjects were randomly assigned to an entry-level oscillating-rotating electric rechargeable brush handle (Oral-B® PRO 1000, D16U) with a round brush head with angled bristles (Oral-B® CrossAction, EB50) or a premium sonic brush (Philips Sonicare® Diamond Clean Toothbrush with AdaptiveClean brush head). One hundred and fifty subjects were instructed to brush twice daily with their assigned brush and a fluoride dentifrice for eight weeks before returning for an oral examination and gingivitis and plaque evaluations. The same methods were used at baseline and Week 8 for all evaluations., Results: One hundred and forty-eight subjects completed the study, 74 in each group. After eight weeks of use, both brushes reduced MGI, GBI, total number of bleeding sites, whole mouth plaque, gingival margin plaque, and proximal plaque (p < 0.001 for each). The oscillating-rotating brush provided statistically significantly greater reductions than the sonic brush for all gingivitis measures, with a 34.8%, 48.4%, and 42.6% greater reduction for MGI, GBI, and number of bleeding sites, respectively, after eight weeks of use (p < 0.001 for each). Significantly greater whole mouth (26.2%) and proximal (38.5%) plaque reductions were also demonstrated at Week 8 for the oscillating-rotating brush versus the sonic brush (p < 0.001)., Conclusions: The entry-level oscillating-rotating brush performed better than the premium sonic brush in the reduction of plaque and gingivitis in this eight-week randomized and examiner-blind study., Competing Interests: Dr. Ccahuana-Vasquez, Ms. Conde, Ms. Cunningham, and Dr. Grender are employees of Procter & Gamble. Dr. Goyal and Mr. Qaqish have no conflicts to disclose. The research was funded by Procter & Gamble., (Copyright© by the YES Group, Inc.)

Purpose: To evaluate the dental stain removal efficacy of two commercially-available manual toothbrushes., Methods: This was a randomized, examiner-blind, parallel-group, two treatment clinical trial of 2 weeks duration. Subjects qualifying for the study had a mean Modified Lobene Stain Index of ≥ 1.5 on at least two anterior teeth. Subjects were randomly allocated to one of two groups, receiving a test manual toothbrush (Oral-B 3D White Radiant) or a positive control (PC) manual brush to be used for 1 minute, twice daily for 2 weeks with a standard, anti-cavity fluoride dentifrice. Subjects were given written and verbal instructions, and the first use was supervised at the baseline visit. Stain was measured at baseline and after 2 weeks of product use. Stain measurements were conducted using the Modified Lobene Stain Index (MLSI) and the Interproximal Modified Lobene Stain Index (IMLSI)., Results: Use of the two manual brushes resulted in statistically significant reductions of surface stain relative to baseline after 2 weeks of use. The mean MLSI composite stain reductions versus baseline were 1.37 for White Radiant and 0.87 for PC (P < 0.001 for both). Using the IMLSI, the mean stain reductions for composite, gingival and interproximal regions were 1.68, 1.20 and 1.68 for White Radiant (P < 0.001) and 1.25, 0.97 and 1.43 for PC (P ≤ 0.002). ANCOVA yielded statistically significant between group differences, with greater composite stain removal observed for White Radiant using both indices (P ≤ 0.025).

Objective: To evaluate and compare the efficacy of an oscillating-rotating (O-R) power toothbrush with a brush head utilizing angled bristles to a marketed sonic toothbrush in the reduction of plaque and gingivitis over an eight-week period., Methods: This study used a randomized, examiner-blind, single-center, two-treatment, parallel group, eight-week design. Subjects with mild-to-moderate plaque and gingivitis were evaluated for baseline whole mouth, gingival margin, and approximal plaque, gingivitis, and gingival bleeding. Clinical assessments were performed using the Modified Gingival Index, Gingival Bleeding Index, and the Rustogi Modified Navy Plaque Index. Subjects received either the O-R brush (Oral-B Professional Care 1000 [D16u] with Oral-B CrossAction brush head [EB50]) or the sonic brush (Sonicare DiamondClean with the standard DiamondClean brush head). Subjects brushed twice daily for two minutes per brushing with the assigned brush and a standard fluoride dentifrice for eight weeks before returning for plaque and gingivitis evaluations using the same methods. Prior to baseline and Week 8 measurements, participants abstained from oral hygiene for 12 hours., Results: One hundred and forty-eight subjects completed the study; 75 in the O-R group and 73 in the sonic group. Both brushes demonstrated statistically significant reductions in plaque and gingivitis over the eight-week study period (p < 0.00 1). The O-R brush was statistically significantly more effective in reducing plaque and gingivitis than the sonic brush. Whole mouth, gingival margin, and approximal plaque reductions were 27.7%, 46.8%, and 29.3% greater, respectively, compared with the sonic brush, while the reductions in gingivitis, gingival bleeding, and number of bleeding sites were 34.6%, 36.4%, and 36.1% greater, respectively, for the O-R brush than for the sonic brush (p < 0.001 for all six measures). No adverse events were observed for either brush., Conclusion: The plaque and gingivitis reductions for the O-R power brush incorporating the angled-bristled brush head were significantly greater than for the sonic power brush.

Objective: To assess a newly developed index to measure interproximal stain and evaluate the stain removal efficacy of two commercially available manual toothbrushes., Methods: This was a randomized, examiner-blind, parallel-group, two-treatment clinical trial of two weeks' duration. Subjects qualified for the study if they had an average Modified Lobene Stain Index of ≥ 1.5 from two anterior teeth. At baseline, subjects brushed in front of a mirror for one minute under supervision. All subjects were provided with a standard 0.243% sodium fluoride dentifrice and were randomly assigned either an Oral-B Pulsar manual brush (OBP) or a Colgate Whitening manual brush (CW) to use for two weeks. Stain was reassessed after two weeks of product use. Stain measurements were conducted using the Modified Lobene Stain Index and the new Interproximal Modified Lobene Stain Index, which allows for assessment of stain in hard-to-reach areas using the same area and intensity scales as the Modified Lobene Stain Index., Results: Use of the two manual brushes resulted in statistically significant reductions in surface stain relative to baseline after two weeks of use. Median stain reductions were 78% and 60% for the OBP and CW, respectively, as measured by the Modified Lobene Stain Index. The mean changes in the composite scores from baseline to week two were 1.85 and 1.57 for the two treatment groups, respectively. Statistically significant reductions from baseline were also found for the intensity and extent of stain measures (p < 0.001). Similar trends were found using the new Interproximal Modified Lobene Index. Composite median stain removal percentages versus baseline were 88% and 73% for the OBP and CW groups, respectively (p < 0.001). For the interproximal sites, a median stain removal of 92% was observed with the OBP brush and 83% reduction with the CW brush. For the gingival sites, the median stain removal percentages were 83% and 50%, respectively For the body region, a median stain removal of 100% was found for both treatment groups. No statistically significant differences were found between the two groups for the mean composite scores for either index., Conclusion: Both manual brushes showed effective stain removal, including interproximal hard-to-reach sites. The Interproximal Modified Lobene Stain Index gave clinically relevant results consistent with the traditional Modified Lobene Stain Index, while allowing assessment of interproximal regions.

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.

Purpose: To compare the efficacy of an oscillating-rotating power toothbrush with a novel brush head incorporating angled CrissCross bristles (Oral-B Pro 7000 SmartSeries and Oral-B CrossAction brush head) versus a marketed sonic toothbrush (Colgate ProClinical A1500 with the Triple Clean brush head) in the reduction of gingivitis and plaque over a 6-week period., Methods: This was a single center, randomized, open label, examiner-blind, 2-treatment, parallel group study. Study participants who met the entrance criteria were enrolled in the study and randomly assigned to one of the two toothbrush groups. Study participants brushed with their assigned toothbrush and a marketed fluoride dentifrice for 2 minutes twice daily at home for 6 weeks. Gingivitis and plaque were evaluated at baseline and Week 6. Gingivitis was assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) and plaque was assessed using the Rustogi Modified Navy Plaque Index (RMNPI). Data was analyzed using the ANCOVA with baseline as the covariate., Results: In total, 130 study participants were randomized to treatment resulting in 64 study participants per group completing the study. Both brushes produced statistically significant (P < 0.001) reductions in gingivitis and plaque measures relative to baseline. The oscillating-rotating,brush with the novel brush head demonstrated statistically significantly (P < 0.05) greater reductions in all gingivitis measures, as well as whole mouth and interproximal plaque measures, compared to the sonic toothbrush. The benefit for the oscillating- rotating brush over the sonic brush was 21.3% for gingivitis, 35.7% for gingival bleeding, 34.7% for number of bleeding sites, 17.4% for whole mouth plaque, and 21.2% for interproximal plaque. There were no adverse events reported or observed for either brush.

Objective: To compare the efficacy of an oscillating-rotating power toothbrush with a novel brush head incorporating angled CrissCross bristles (Oral-B Triumph with SmartGuide with Oral-B CrossAction brush head) versus a sonic toothbrush (Sonicare DiamondClean) for plaque and gingivitis reduction over a six-week period., Methods: This was a single-center, randomized, examiner-blind, two-treatment, parallel group study involving 65 subjects per group. Subjects presenting with mild-to-moderate gingivitis at Baseline were randomly assigned to either the oscillating-rotating brush or the sonic brush. They were instructed to use their assigned toothbrush and a standard fluoride dentifrice for two minutes twice daily at home for six weeks. Gingivitis and plaque were assessed at Baseline and Week 6 using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and Rustogi Modified Navy Plaque Index (RMNPI). Data were analyzed using an Analysis of Covariance (ANCOVA), with baseline as the covariate. Subjects also completed a consumer perception questionnaire to evaluate their brushing experience., Results: One-hundred and thirty subjects were enrolled in the study and randomized to treatment. Sixty-four subjects per group completed the trial. Both brushes produced statistically significant reductions in gingivitis and plaque measures at Week 6 relative to Baseline (p < 0.001 for all). The oscillating-rotating brush with the novel brush head demonstrated statistically significantly greater reductions in all gingivitis and plaque measures compared to the sonic toothbrush. The benefits for the oscillating-rotating brush over the sonic brush were 32.6% for gingivitis, 35.4% for gingival bleeding, 32% for number of bleeding sites, 22% for whole mouth plaque, 24.2% for gingival margin plaque, and 33.3% for approximal plaque (p < or = 0.001 for all measures except gingival margin plaque, where p = 0.018). Analysis of the consumer perception questionnaire results showed subjects using the oscillating-rotating brush rated it higher for overall use experience and key attributes related to cleaning, gentleness, and brush head shape/size versus subjects in the sonic brush group. There were no adverse events reported or observed for either brush., Conclusion: This six-week randomized, examiner-blind, comparative clinical study showed the oscillating-rotating toothbrush, with a novel brush head incorporating angled CrissCross bristles, was significantly better than an advanced sonic power toothbrush at reducing gingival inflammation and bleeding, as well as reducing whole mouth plaque, plaque along the gumline, and in the approximal regions.

Objective: To evaluate the efficacy of a marketed oscillating-rotating (O-R) power toothbrush (Oral-B Triumph with SmartGuide and FlossAction brush head, D34/EB25) to a new sonic toothbrush (Sonicare FlexCare Platinum) in the reduction of gingivitis and plaque over a 12-week test period., Methods: This was a single center, randomized, open label, examiner-blind, two-treatment, parallel group study. Subjects who met the entrance criteria were enrolled in the study and randomly assigned to either the O-R or sonic treatment group. Subjects brushed with their assigned toothbrush and a marketed fluoride dentifrice for two minutes twice daily at home for 12 weeks. Gingivitis and plaque were evaluated at Baseline, Week 6, and Week 12. Gingivitis was assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI), and plaque was assessed using the Rustogi Modified Navy Plaque Index (RMNPI). Data were analyzed using an Analysis of Covariance (ANCOVA) with Baseline as the covariate., Results: In total, 130 subjects (65 per group) were randomized to treatment and 127 subjects completed the study. Both brushes produced statistically significant (p < 0.001) reductions in gingivitis and plaque measures relative to Baseline. At Week 12, the O-R brush demonstrated significantly greater reductions than the sonic brush in whole mouth gingivitis measures (p = 0.007). Additionally, the O-R brush presented significantly fewer bleeding sites (p < 0.007) and significantly greater reductions in whole mouth plaque measures (p < or = 0.035) at Weeks 6 and 12 versus the sonic brush. The benefit for the O-R brush versus the sonic brush at Week 12 was 11.7% for gingivitis, 19.8% for number of bleeding sites, and 12.2% for whole mouth plaque. There were no adverse events reported or observed for either brush., Conclusion: The oscillating-rotating toothbrush demonstrated statistically significantly greater reductions in whole mouth plaque at Weeks 6 and 12, as well as significantly greater gingivitis reductions over the long-term (12 weeks), compared to the new sonic toothbrush.

Objective: The aim of this investigation was to assess the comparative gingivitis and plaque reduction efficacy of a leading oscillating-rotating power toothbrush and a recently introduced sonic toothbrush in adults with gingivitis., Methods: This was a 12-week, randomized and controlled, parallel group, examiner-blind, single-center clinical study of 130 adults with pre-existing gingivitis and plaque. At baseline, the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and total number of bleeding sites were assessed, along with plaque levels (whole mouth, gingival margin, and interproximal) via the Rustogi Modified Navy Plaque Index (RMNPI). Qualified subjects were randomly assigned to one of two power toothbrush test groups: the Oral-B Triumph with SmartGuide (marketed in the United States as the Oral-B Professional Care SmartSeries 5000 [D34]) oscillating-rotating brush, or the Colgate ProClinical A1500 (also marketed as elmex ProClinical) sonic brush. Subjects brushed at home for two minutes twice daily with their assigned power toothbrush and a marketed sodium fluoride dentifrice, and were reevaluated for gingivitis at Week 4 and Week 12 via the MGI, GBI, and total number of bleeding sites, and for plaque reduction via the RMNPI., Results: Ninety-seven percent (97%) of the 130 enrolled subjects completed the trial and 62 and 65 subjects in the oscillating-rotating and sonic brush groups, respectively, had evaluable data for analysis. Statistically significant mean reductions in all three gingivitis parameters and plaque relative to baseline were seen at both Weeks 4 and 12 with unsupervised use of both test toothbrushes (p < 0.001). The oscillating-rotating power brush provided statistically significantly superior reductions compared to the sonic brush in mean adjusted MGI (31% and 29% at Weeks 4 and 12, respectively; p < 0.001), GBI (17% at Week 12; p = 0.047), and total number of bleeding sites (48% and 30% at Weeks 4 and 12, respectively; p = 0.002), and produced statistically significantly greater relative mean adjusted plaque reductions for RMNPI whole mouth plaque (38% and 24% at Weeks 4 and 12, respectively; p < 0.001), gingival margin plaque (36% at Week 4; p = 0.004), and interproximal plaque (39% and 26% at Weeks 4 and 12, respectively; p < 0.001). Both power toothbrushes were well-tolerated., Conclusion: An advanced oscillating-rotating power toothbrush produced substantial, statistically superior reductions in plaque and gingivitis via multiple outcome measures compared to a new sonic toothbrush after both four weeks and 12 weeks of tooth brushing.

Purpose: To evaluate the efficacy of an advanced rotation/oscillation power toothbrush (Oral-B Triumph with SmartGuide) relative to a new sonic power toothbrush (Sonicare DiamondClean) in the reduction of gingivitis and plaque over a period of 12 weeks., Methods: This was a single-center, open-label, examiner-blind, two-treatment, parallel group, randomized study in which subjects brushed with their assigned toothbrush and a marketed dentifrice for 2 minutes twice daily at home for 12 weeks. Gingivitis and plaque were evaluated at baseline, Week 6 and Week 12 using the Modified Gingival Index (MGI), Number of Bleeding Sites, and Rustogi Modification of the Navy Plaque Index (RMNPI). Safety was also assessed at every visit. At the end of the study, subjects completed a consumer questionnaire to evaluate their brushing experience., Results: In total, 130 subjects were randomized to treatment and completed the study (65 per group). The rotation/oscillation group had higher gingivitis reductions from baseline at Weeks 6 and 12 by 31.9% and 32.3%, respectively, for MGI and by 43.4% and 34.9%, respectively, for number of bleeding sites than the sonic group. Group differences at both Weeks 6 and 12 were highly significant (P < 0.001) for both MGI and number of bleeding sites. The rotation/oscillation group had higher RMNPI plaque reductions from baseline at Weeks 6 and 12 by 15.8% and 19.3%, respectively, for whole mouth; by 24.1% and 30.4% at the gumline; and by 22.9% and 24.4% in the approximal regions, than the sonic group. Comparisons between groups at Week 12 were highly significant (P < or = 0.002) for all three mouth areas; group differences at Week 6 were significant (P < 0.05) for whole mouth and approximal RMNPI. Analysis of the questionnaire data showed that subjects using the rotation/oscillation brush rated it higher for several key attributes than subjects in the sonic group. There were no safety concerns with either brush.

Purpose: To evaluate the plaque- and gingivitis-reducing efficacy of a newly developed multi-directional power toothbrush in comparison to a commercially-available sonic power toothbrush., Methods: Adult subjects with mild-to-moderate gingivitis were eligible for this 4-week, randomized and controlled, single-center, examiner-blinded, parallel group study. At baseline, plaque and gingivitis status was assessed with the Rustogi Modified Navy Plaque Index (RMNPI), Lobene Modified Gingival Index (MGI), and Gingival Bleeding Index (GBI). Subjects meeting all eligibility criteria were randomly assigned to one of two power toothbrushes: a novel multi-directional power toothbrush (Oral-B Professional Deep Sweep TRICLEAN 1000 also marketed as Oral-B TriZone) or the marketed sonic control toothbrush (Philips Sonicare Essence 5500). A single supervised brushing occurred onsite at baseline; thereafter toothbrushing was conducted twice daily at home in accordance with manufacturer instructions using the assigned power brush. At 4 weeks post-baseline, subjects returned for MGI, GBI, and RMNPI evaluations to determine the plaque and gingivitis efficacy of the respective brushes., Results: All 130 subjects completing the trial were evaluable. Both the novel multi-directional power and sonic control brushes produced significant mean reductions in gingivitis, gingival bleeding and plaque (whole mouth and region-specific) at Week 4 in comparison to baseline (P < 0.001). The new multi-directional power brush performed statistically significantly better (P < or = 0.001) in all efficacy measures after 4 weeks ofbrushing, providing superior adjusted mean relative reduction benefits versus the sonic control brush of 48% for MGI, 52% for GBI, 26% for whole mouth RMNPI, 58% for gingival margin RMNPI plaque, and 33% for interproximal (approximal) RMNPI plaque. Both toothbrushes were well-tolerated.

Purpose: To evaluate the efficacy of a novel multi-directional power toothbrush in reducing plaque and gingivitis relative to a standard manual toothbrush control., Methods: This 4-week, randomized and controlled, single-center, parallel group, examiner-blinded clinical study enrolled adults with mild-to-moderate gingivitis. At baseline, pre-treatment gingivitis and plaque levels were assessed via the Lobene Modified Gingival Index (MGI), the Gingival Bleeding Index (GBI), and the Rustogi Modified Navy Plaque Index (RMNPI). Subjects qualifying were assigned randomly to one of two toothbrush groups: a novel multi-directional power toothbrush (Oral-B Professional Deep Sweep TRICLEAN 1000, also marketed as Oral-B TriZone) or a standard soft manual control toothbrush. Aside from a supervised brushing at baseline on-site, subjects brushed at home twice daily with their assigned test brush. After 1 week, subjects returned for RMNPI plaque evaluations. At Week 4, subjects were again recalled to evaluate toothbrush efficacy, and received MGI and GBI gingivitis and RMNPI plaque evaluations., Results: 119 evaluable subjects completed the study. Both the novel power and manual control toothbrushes yielded statistically significant (P < 0.001) mean plaque reductions compared to baseline at Weeks 1 and 4 (except Week 1 manual brush gingival margin) and significant mean MGI and GBI gingivitis reductions (P < 0.001). Comparing the relative effectiveness of the test brushes, the novel multi-directional power brush produced significantly superior anti-gingivitis and anti-plaque reductions compared to pre-treatment relative to the manual control brush in every analysis at both time points. The Week 4 adjusted mean relative reductions favoring the multi-directional power brush were 3 and 1.49 times greater for whole mouth MGI and GBI, respectively (P < 0.001); and were 2.1, 4.7 and 2 times greater for the RMNPI whole mouth, gingival margin and interproximal regions, respectively (P < 0.001). Both toothbrushes were well-tolerated.

Purpose: To determine the effectiveness of a new multi-directional power toothbrush in reducing plaque when compared to a standard manual toothbrush control in a single brushing design., Methods: This was a randomized, replicate use, single-brushing, two-treatment, four-period, examiner-blinded crossover clinical trial at a single center. Qualified subjects entered an acclimation phase, after which they were randomly assigned to one of four treatment sequences specifying the order of use of the two test toothbrushes: a novel multi-directional power toothbrush with a 2-D drive (Oral-B Vitality TriZone) and an American Dental Association (ADA) reference soft manual brush. Subjects used each brush twice over the course of the trial. At each of the four period visits, after abstaining from oral hygiene for 24 hours, participants received a baseline (pre-brushing) Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) examination. They then brushed under supervision with the brush assigned for that period for 2 minutes (multi-directional power brush) or as customary (manual brush control). Subjects were then re-examined for TMQHPI post-brushing to determine the plaque removal efficacy of the respective brushes. A washout phase of 2-5 days separated treatment periods. TMQHPI scores were averaged on a per-subject basis, and analyzed using a mixed model analysis of covariance for a crossover design., Results: All 36 randomized subjects completed the study and were fully evaluable. Both the multi-directional power and manual control brushes produced statistically significant mean whole mouth TMQHPI plaque reductions compared to baseline (P < 0.001). Comparing the brushes, the power brush provided a 7.9% significantly superior mean whole mouth plaque reduction relative to the manual brush control (P= 0.003). Both toothbrushes were well-tolerated.

Purpose: To assess the ability of a novel multi-directional power toothbrush to control plaque and gingivitis when compared to a marketed sonic power toothbrush control., Methods: This was a randomized and controlled, examiner-blinded, parallel group, 8-week study at a single center, in adult subjects with mild-to-moderate gingivitis. Pre-treatment gingivitis levels and plaque coverage were evaluated at baseline using the Lobene Modified Gingival Index (MGI), the Gingival Bleeding Index (GBI), and the Rustogi Modified Navy Plaque Index (RMNPI). Qualified subjects were randomly assigned to either a novel multi-directional power toothbrush with a wireless display (Oral-B Professional Deep Sweep + SmartGuide TRICLEAN 5000, also marketed as Oral-B TriZone) or the marketed control sonic toothbrush (Philips Sonicare FlexCare). After a supervised brushing at the clinical site at baseline, subjects brushed unsupervised at home twice daily according to manufacturer instructions with the assigned test brush and standard sodium fluoride dentifrice. After 8 weeks, subjects were recalled to assess toothbrush efficacy via the MGI and GBI gingivitis and RMNPI plaque evaluations., Results: A total of 128 evaluable subjects completed the study. After 8 weeks of brushing, both test toothbrushes provided statistically significant reductions compared to baseline in mean whole mouth MGI and GBI, and in RMNPI whole mouth and interproximal (approximal) sites (P < 0.001). The novel multi-directional power brush consistently produced significantly superior anti-gingivitis and anti-plaque reductions relative to pre-treatment versus the sonic control brush: the Week 8 adjusted mean relative reductions were 30% and 29% greater for whole mouth MGI and GBI, respectively (P < 0.001); and were 44% and 77% greater for the RMNPI whole mouth and interproximal regions, respectively (P < or = 0.003). Both toothbrushes were well-tolerated.

Purpose: To compare the safety and efficacy of a novel sonic power toothbrush and a manual toothbrush in the reduction of gingivitis and plaque over a 4-week period., Methods: This study employed a randomized two treatment, examiner-blinded, parallel group design. Subjects with evidence of gingivitis were randomly assigned to 4 weeks' twice daily home use of either the Oral-B Pulsonic sonic toothbrush or an ADA reference manual toothbrush. At baseline (Visit 1) and again after product use at Week 4, subjects received gingivitis evaluations with the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) examinations, followed by plaque assessment using the Rustogi Modified Navy Plaque Index (RMNPI). For 12 hours before both visits, subjects abstained from all oral hygiene, and ceased eating, drinking and smoking 4 hours prior., Results: Both brushes significantly reduced gingivitis, gingival bleeding and plaque compared with baseline, and were well-tolerated by the 129 subjects completing the study. The sonic toothbrush was statistically significantly (P < 0.0001) more effective than the manual brush, with greater relative mean reductions in MGI, GBI and RMNPI of 11.9%, 62.3% and 46.5%, respectively.

Purpose: To compare the plaque removing efficacy of Oral-B Advantage 123 and Colgate 360 degrees manual toothbrushes on a single brushing after a 24-hour void in oral hygiene., Methods: This study had a two-treatment (Advantage 123 versus Colgate 360 degrees), examiner-blind, randomized, four-period (visit) crossover design. At the first (baseline) visit, subjects received a plaque examination using the Rustogi Modified Navy Plaque Index (RMNPI) after which they were instructed to brush for 1 minute in their normal manner with their assigned toothbrush and a marketed dentifrice and unaided by access to a mirror. Post-brushing plaque was then assessed. At three further visits, each separated by a period of 3-8 days, brushes were assigned to subjects according to their treatment sequence and the same brushing and plaque grading procedure as at baseline was followed., Results: 50 subjects were enrolled in the replicate single-use study; all were included in the analysis. Oral-B Advantage 123 was significantly better than Colgate 360 degrees at reducing whole mouth (P = 0.006), gingival margin (P = 0.010) and approximal (P = 0.040) plaque scores.

Objective: To assess the extrinsic stain removal benefit of two different power toothbrushes: an experimental Oral-B Pulsonic rechargeable toothbrush and a positive control Sonicare FlexCare toothbrush., Methods: This was a randomized, positive-controlled, examiner-blind, two-treatment, parallel group, two-week study. A Lobene stain index was performed at baseline on the facial surfaces of the anterior teeth. Subjects were randomized to one of two treatment groups: Pulsonic or FlexCare. Both groups were assigned the same fluoride dentifrice, and were instructed to brush their teeth twice per day for two minutes with the assigned toothbrush and dentifrice in front of a mirror. A further Lobene stain index was performed following two weeks of brushing., Results: A highly significant reduction (p < 0.001) in mean Lobene composite scores after two weeks was found for both the Pulsonic treatment group and the FlexCare treatment group (median reduction of 94.4% and 90.7%, respectively). Both treatment groups also showed a highly significant (p < 0.001) reduction in extent and intensity scores. No significant treatment group differences were seen in the reduction in mean Lobene scores (p > 0.1)., Conclusion: Both the experimental Pulsonic and the positive control FlexCare power toothbrushes showed highly effective stain removal efficacy relative to baseline following two weeks of brushing. Stain removal efficacy did not differ significantly between brushes.

Aim: To assess extrinsic stain removal efficacy of a power toothbrush and a dental prophylaxis followed by the use of a standardized American Dental Association (ADA) reference manual toothbrush., Methods and Materials: This was a randomized, positive-controlled, examiner-blind, parallel group, two-week study. A Lobene stain examination was performed at baseline. Subjects were randomized to one of two treatment groups: Group 1: Oral-B Vitality Pro White power toothbrush or Group 2: Subjects receiving a dental prophylaxis then using a standardized ADA reference manual toothbrush. Subjects were instructed to brush their teeth with the assigned toothbrush and a fluoride dentifrice in front of a mirror twice per day for 2 minutes. Stain was reassessed following 2 weeks of brushing., Results: A significant reduction (p <0.001) in mean Lobene composite scores after 2 weeks was found for Group 1 (90.6%) and Group 2 (94.4%). Both groups also showed a significant reduction (p <0.001) in extent and intensity scores. There was no significant group difference in reduction in mean Lobene composite scores (p>0.1)., Conclusions: The Oral-B Vitality Pro White power toothbrush showed effective stain removal at a level similar to receiving an oral prophylaxis followed by the use of an ADA reference manual toothbrush., Clinical Significance: In this small study the Oral-B Vitality Pro White power toothbrush achieved statistically significant stain removal between dental visits.

Objective: The aim of this study was to evaluate the efficacy of a single night-time dose of a syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate in subjects with multiple cold symptoms., Materials: A syrup containing 15 mg dextromethorphan hydrobromide, 7.5 mg doxylamine succinate, 600 mg paracetamol and 8 mg ephedrine sulfate (Wick MediNait produced by WICK Pharma, Germany, a subsidiary of Procter & Gamble GmbH; test syrup) or placebo (placebo syrup) for oral administration., Methods: This was a randomized, double-blind, placebo-controlled, multi-center, parallel design study. At enrollment, eligible subjects had to have at least moderate nasal congestion and a runny nose, at least mild cough and at least mild pain with one or more of the following: sore throat, sore chest, headache or body pain/aches. Subjects were randomized into either Group T (test syrup) or Group P (placebo syrup). On the evening of enrollment, subjects rated baseline symptoms, ingested the assigned study product and completed symptom-relief assessments at 3 hours post-dosing. Within one hour of awakening the following morning, subjects completed night-time symptom relief and sleep satisfaction assessments. All symptoms were recorded using an Interactive Voice Response system. Treatment comparisons were made after adjusting for the severity of baseline symptom using analysis of covariance., Results: Of 485 subjects who took the study product, 432 (224 in Group T; 208 in Group P) were evaluable for analysis. For the primary endpoint (composite of nasal congestion/runny nose/cough/pain relief scores 3 hours post-dosing), subjects in Group T had clinically and statistically significantly greater relief than Group P (p = 0.0002). Each individual symptom score also showed statistically significant improvement at this time point (p < or = 0.017). The next morning, Group T continued to show clinically and statistically significant benefits over Group P on the composite score and each of the individual symptoms (p < or = 0.003). Evidence of benefit with the test syrup was also seen in the higher score for overall night-time relief (p < 0.0001) and greater satisfaction on sleep (p = 0.002) compared to placebo syrup. Improvement in individual symptoms after 3 hours was obtained in 16-42% more subjects in Group T than in Group P, whereas the percentage of subjects in Group T having Good or Very Good relief the morning after dosing increased by 25-68% compared to subjects in Group P. 14 subjects (5 in Group T; 9 in Group P) reported AEs but none of these occurred with an incidence greater than 1%. There were no serious AEs., Conclusions: The results confirm the multisymptom benefit of a single dose of the test syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate and support its role as an effective and convenient therapy for symptoms of nasal congestion, runny nose, cough and pain/body aches associated with the common cold and for increasing sleep quality disturbed by the common cold.

Background: The onset of acid inhibition for proton pump inhibitors is slower than with H2RAs and generally considered to be at a steady-state after 5 days. Thus, little direct comparison data exists between H2RAs and proton pump inhibitors for gastric acid suppression on day 1 of therapy. Furthermore, the durability of their acid suppression has not been systematically compared., Aim: To compare the effects of 20.6 mg omeprazole magnesium o.m. (Ome-Mg 20), famotidine 10 mg b.d. (Fam 10) and famotidine 20 mg b.d. (Fam 20) on intragastric pH on day 1 and throughout 14 days of dosing., Methods: The study was a randomized, double-blind, three-dosing regimens, three-period crossover. Healthy adults with frequent heartburn (> or =2 days/week) underwent 24-h gastric pH monitoring on days 0 (baseline), 1, 3, 7 and 14., Results: Thirty-one subjects were included in the per-protocol analyses. On day 1, the mean percentage time pH > 4 (pH4%) was higher for Ome-Mg 20, 44.6%, than for Fam 10, 36.7% (P = 0.032), and not different from Fam 20, 46.9% (P = 0.541). The pH4% was higher for Ome-Mg 20 than either famotidine regimen on all subsequent monitoring days (P < 0.001). The 24-h area under the mean intragastric pH curve showed a similar pattern. Furthermore, after day 1, Ome-Mg 20 demonstrated an increasing and sustained effect in contrast to a decreasing effect for famotidine, consistent with H2RA tolerance., Conclusion: Gastric acid suppression on Ome-Mg 20 mg o.m. over 14 days was comparable with Fam 10 mg b.d. or Fam 20 mg b.d. on day 1, and superior thereafter.

We discuss the statistical analysis of data from two clinical trials using crossover designs. In both studies, response was observed repeatedly over time in each treatment period. The first study involves repeated measurements of a single response variable whereas the second involves bivariate response. Methods are described for fitting polynomial growth curves to achieve data reduction in a two-stage approach to the analysis of crossover designs. Thus, a multivariate parametric analysis frequently can be conducted even when the sample sizes are somewhat small as is the case in many crossover designs. Hypotheses that are usually of interest in crossover designs can be tested in the second stage of the analysis. Methods for testing the multivariate general linear hypothesis as a basis for statistical inference in such problems are discussed.

Subsampling can be used in experimental design to investigate extraneous sources of variability. One useful strategy is to make independent replicate measurements of the response variate. This can be achieved in clinical studies, for example, by dividing a blood or urine specimen from each of a sample of subjects into aliquots and processing these through a chemistry laboratory in such a way that the replicate determinations are independent. This procedure can be used to increase design efficiency. This paper addresses considerations in the design and analysis of the 2 x 2 crossover plan with this type of subsampling.

Nonparametric methods are presented for the analysis of the two-treatment, two-period crossover design with multivariate response. After forming within-subject sums and differences, the usual tests, including those for carry-over effects and direct treatment effects, can be constructed using a multivariate analysis of variance. When the assumptions relevant to traditional analysis are in question, multivariate nonparametric tests based on ranks provide a realistic alternative. However, multivariate response gives rise to a wider class of hypotheses than is seen in crossover designs with univariate response. We discuss these hypotheses and formulate nonparametric tests for associated analyses.

Crossover designs involve observing the same response variate under different experimental conditions for each subject. Univariate methods are commonly used for analysis of data arising in these designs, but multivariate procedures offer a more general approach. The general multivariate linear model provides a natural framework for the simplest data structure as well as more complex settings with two or more response variates and measurements repeated over time. Multivariate models for crossover designs provide a unified approach that clarifies specification of hypotheses, assumptions required, and testing procedures in a wide class of applications that include longitudinal data as a special case. We focus on the 2 x 2 crossover design, but also describe models for analysing more complex crossover designs.

Clinical trials often involve the study of patients whose values for some quantitative characteristic are in the extreme of the distribution for the normal population. Subsequent observation of the characteristic of interest will ordinarily tend to regress toward the mean of the distribution even in the absence of a treatment effect. We consider the impact of regression toward the mean in the analysis of data arising in 2 x 2 crossover trials with two baseline measurements. The usual summary statistics can be especially misleading in the presence of regression toward the mean.