Quantitative analysis of the effects of brushing, flossing, and mouthrinsing on supragingival and subgingival plaque microbiota: 12-week clinical trial.

BACKGROUND: Translational microbiome research using next-generation DNA sequencing is challenging due to the semi-qualitative nature of relative abundance data. A novel method for quantitative analysis was applied in this 12-week clinical trial to understand the mechanical vs. chemotherapeutic actions of brushing, flossing, and mouthrinsing against the supragingival dental plaque microbiome. Enumeration of viable bacteria using vPCR was also applied on supragingival plaque for validation and on subgingival plaque to evaluate interventional effects below the gingival margin. METHODS: Subjects with gingivitis were enrolled in a single center, examiner-blind, virtually supervised, parallel group controlled clinical trial. Subjects with gingivitis were randomized into brushing only (B); brushing and flossing (BF); brushing and rinsing with Listerine® Cool Mint® Antiseptic (BA); brushing and rinsing with Listerine® Cool Mint® Zero (BZ); or brushing, flossing, and rinsing with Listerine® Cool Mint® Zero (BFZ). All subjects brushed twice daily for 1 min with a sodium monofluorophosphate toothpaste and a soft-bristled toothbrush. Subjects who flossed used unflavored waxed dental floss once daily. Subjects assigned to mouthrinses rinsed twice daily. Plaque specimens were collected at the baseline visit and after 4 and 12 weeks of intervention. Bacterial cell number quantification was achieved by adding reference amounts of DNA controls to plaque samples prior to DNA extraction, followed by shallow shotgun metagenome sequencing. RESULTS: 286 subjects completed the trial. The metagenomic data for supragingival plaque showed significant reductions in Shannon-Weaver diversity, species richness, and total and categorical bacterial abundances (commensal, gingivitis, and malodor) after 4 and 12 weeks for the BA, BZ, and BFZ groups compared to the B group, while no significant differences were observed between the B and BF groups. Supragingival plaque vPCR further validated these results, and subgingival plaque vPCR demonstrated significant efficacy for the BFZ intervention only. CONCLUSIONS: This publication reports on a successful application of a quantitative method of microbiome analysis in a clinical trial demonstrating the sustained and superior efficacy of essential oil mouthrinses at controlling dental plaque compared to mechanical methods. The quantitative microbiological data in this trial also reinforce the safety and mechanism of action of EO mouthrinses against plaque microbial ecology and highlights the importance of elevating EO mouthrinsing as an integral part of an oral hygiene regimen. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov on 31/10/2022. The registration number is NCT05600231.

Quantitative analysis of the effects of essential oil mouthrinses on clinical plaque microbiome: a parallel-group, randomized trial.

BACKGROUND: The rich diversity of microorganisms in the oral cavity plays an important role in the maintenance of oral health and development of detrimental oral health conditions. Beyond commonly used qualitative microbiome metrics, such as relative proportions or diversity, both the species-level identification and quantification of bacteria are key to understanding clinical disease associations. This study reports the first-time application of an absolute quantitative microbiome analysis using spiked DNA standards and shotgun metagenome sequencing to assess the efficacy and safety of product intervention on dental plaque microbiome. METHODS: In this parallel-group, randomized clinical trial, essential oil mouthrinses, including LISTERINE® Cool Mint Antiseptic (LCM), an alcohol-containing prototype mouthrinse (ACPM), and an alcohol-free prototype mouthrinse (AFPM), were compared against a hydroalcohol control rinse on clinical parameters and the oral microbiome of subjects with moderate gingivitis. To enable a sensitive and clinically meaningful measure of bacterial abundances, species were categorized according to their associations with oral conditions based on published literature and quantified using known amounts of spiked DNA standards. RESULTS: Multivariate analysis showed that both LCM and ACPM shifted the dysbiotic microbiome composition of subjects with gingivitis to a healthier state after 4 weeks of twice-daily use, resembling the composition of subjects with clinically healthy oral conditions recruited for observational reference comparison at baseline. The essential oil-containing mouthrinses evaluated in this study showed statistically significant reductions in clinical gingivitis and plaque measurements when compared to the hydroalcohol control rinse after 6 weeks of use. CONCLUSIONS: By establishing a novel quantitative method for microbiome analysis, this study sheds light on the mechanisms of LCM mouthrinse efficacy on oral microbial ecology, demonstrating that repeated usage non-selectively resets a gingivitis-like oral microbiome toward that of a healthy oral cavity. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov on 10/06/2021. The registration number is NCT04921371.

Efficacy of flossing and mouth rinsing regimens on plaque and gingivitis: a randomized clinical trial.

BACKGROUND: To investigate the effects of combinations of mechanical (brushing and flossing) and chemotherapeutic regimens which included essential oils (EO) non-alcohol and alcohol-containing mouthrinses compared to brushing only in the prevention and reduction of plaque, gingivitis, and gingival bleeding. METHODS: This was a randomized, virtually supervised, examiner blind, controlled clinical trial. Following informed consent and screening, subjects (N = 270) with gingivitis were randomly assigned to one of the following regimens: (1) Brush Only (B, n = 54); (2) Brush/Rinse (EO alcohol-containing mouthrinse) (BA, n = 54); (3) Brush/Rinse (EO non-alcohol containing mouthrinse) (BZ, n = 54); (4) Brush/Floss (BF, n = 54); (5) Brush/Floss/Rinse (EO non-alcohol containing mouthrinse) (BFZ, n = 54). Unflavored waxed dental floss (REACH unflavored waxed dental floss), and fluoridated toothpaste (Colgate Cavity Protection) were used. Examinations included oral hard and soft tissue, plaque, gingivitis, gingival bleeding, probing depth and bleeding on probing. RESULTS: After 12 weeks, both BA and BZ and the BFZ group were superior in reducing interproximal plaque (30.8%, 18.2%, 16.0%, respectively), gingivitis (39.0%, 36.9%, 36.1%, respectively), and bleeding (67.8%, 73.6%, 79.8%, respectively) compared to B. The BF group did not provide significant reductions in interproximal plaque but did reduce interproximal gingivitis (5.1%, p = 0.041) at Week 4 and bleeding at Weeks 4 and 12 (34.6%, 31.4%, p < 0.001 respectively) compared to B. The BFZ group did not significantly reduce interproximal plaque, gingivitis or bleeding compared to BZ. CONCLUSIONS: This study demonstrated that the addition of EO non-alcohol containing mouthrinse to the manual toothbrushing and flossing regimen further reduces plaque, gingivitis and bleeding showing that addition of EO mouthrinses (alcohol or non-alcohol containing) to the oral hygiene regimen provides sustained reductions in plaque to help maintain gingival health after a dental prophylaxis. Dental professional recommendation of the addition of an EO non-alcohol containing mouthrinse to daily oral hygiene routines of brushing or brushing and flossing should be considered to aid supragingival plaque control and improve gingivitis prevention. STUDY REGISTRY NUMBER: NCT05600231.

Comparative Effectiveness of Toothbrushing, Flossing and Mouthrinse Regimens on Plaque and Gingivitis: A 12-week virtually supervised clinical trial.

Purpose:Various mechanical and chemotherapeutic methods are used to control dental plaque accumulation and prevent or reduce gingivitis. The purpose of this 12-week clinical trial was to investigate the effects of various combinations of supervised mechanical and chemotherapeutic regimens on the prevention and reduction of plaque, gingivitis, and gingival bleeding.Methods:Volunteers presenting with some evidence of gingivitis and no severe periodontitis were randomized into four groups: brush only (BO); brush/rinse (BR); brush/floss (BF); brush/floss/rinse (BFR) for this examiner-blinded clinical trial. Toothbrush, toothpaste, floss and a mouthrinse containing a fixed combination of four essential oils (EO) and training/instructions were provided to participants as per their assigned group. Participants performed their regimen at home, under virtual supervision, once each weekday; the second daily and weekend uses were unsupervised. Assessments included oral hard and soft tissue, plaque, gingivitis, and gingival bleeding (weeks 4, 12); probing depth and bleeding on probing (week 12).Results:Of 213 enrolled participants, 209 completed the study. After 12 weeks, plaque, gingivitis, and gingival bleeding were significantly reduced in groups BR (35.8%, 50.8%, and 71.0% respectively, p<0.001) and BFR (32.8%, 54.1%, and 78.2% respectively, p<0.001) compared to BO. After 12 weeks, gingivitis and gingival bleeding were significantly reduced in the BF group (9.2%, p=0.013 and 17.5%, p=0.003, respectively), however there were no significant reductions in plaque in the BF group as compared to the BO group (p=0.935).Conclusions:Oral care regimens that included a mouthrinse containing a fixed combination of four EOs (BR and BFR), demonstrated statistically significantly reduced plaque, gingivitis, and gingival bleeding as compared to BO and BF after 12 weeks. The BF regimen statistically significantly reduced gingivitis and gingival bleeding but did not statistically significantly reduce plaque compared to BO after 12 weeks.

Role of Manual Dexterity on Mechanical and Chemotherapeutic Oral Hygiene Regimens.

Purpose:Effective use of mechanical plaque control devices can depend on individual manual dexterity levels. The purpose of this component of a 12-week, virtually-supervised clinical trial was to investigate the role of manual dexterity on clinical outcomes for gingivitis, as measured by the relationship between manual dexterity scores on the Purdue Pegboard Test (PPT) and the effects of various mechanical and chemotherapeutic oral hygiene regimens.Methods:This was a single-center, examiner blinded, randomized, four-treatment arm, parallel group, 12-week plaque and gingivitis study. At baseline, healthy adult volunteers with evidence of gingivitis were assessed for manual dexterity and were then examined for plaque, gingivitis and bleeding. After a dental prophylaxis, participants were randomized into four treatment groups: brush only (BO); brush/rinse (BR); brush/floss (BF); and brush/floss/rinse (BFR). The flossing groups received instruction in flossing. The PPT was used to assess manual dexterity and was performed by a licensed occupational therapist. Virtual supervision was required once each weekday and the oral hygiene regimen was unsupervised on evenings and weekends.Results:Of the 213 subjects enrolled, 209 completed the trial. Improvements from baseline to week 12 in interproximal percent nonbleeding healthy sites (Expanded Bleeding Index (EBI)=0 and Modified Gingival Index (MGI)=0 or 1) were dependent on the participant's dexterity score. Participants with the lowest dexterity scores (9 or lower) in the BFR treatment group demonstrated the greatest improvement interproximally based on the indices (EBI and MGI). In comparison, the BF test group subjects with dexterity scores 9 or lower had limited change in improvement interproximally. There was a direct correlation between flossing effectiveness and dexterity scores.Conclusions:Less manual dexterity can limit dental flossing effectiveness. Flossing is a difficult daily task that requires functional bilateral dexterity to be perform correctly. Individuals with lower levels of manual dexterity were shown to benefit from the addition of an essential oil mouthrinse to a regimen of toothbrushing and flossing in this clinical trial. The addition of an essential oil mouthrinse improved interproximal gingival health and mitigated the manual dexterity variable.

Efficacy of Flossing and Mouthrinsing Regimens on Plaque and Gingivitis: A randomized clinical trial.

Purpose:Flossing is a well-known component of daily recommended oral care regimens, but patients often find it challenging to perform effectively on a regular basis. The purpose of this 12-week supervised clinical trial was to investigate the effects of twice daily rinsing with a mouthrinse containing a fixed combination of four essential oils (4EO) and supervised daily dental flossing regimens as compared to a negative control 5% hydroalcohol rinse (NC) on the prevention and reduction of plaque, gingivitis, and gingival bleeding.Methods:Volunteer participants who met the inclusion criteria were randomized into the following groups for the 12- week trial: 1) NC; 2) mouthrinse containing 4EO; 3) professional flossing performed by a dental hygienist (FBH); 4) supervised self-flossing (FUS). All participants received a professional dental prophylaxis prior to beginning the trial. On weekday mornings, all participants brushed on site. After brushing, the rinse groups used their products under supervision, and the floss groups had their teeth flossed by a dental hygienist or self-flossed under supervision. Participants performed their assigned regimen in the evenings and the twice-daily weekend use at home. Each individual assessment of oral hard and soft tissue, plaque, gingivitis, and gingival bleeding at weeks 4 and 12, probing depth and bleeding on probing at week 12 was made by the same calibrated examiner.Results:Of 156 randomized participants, 149 completed the trial. Use of the 4EO mouthrinse statistically significantly reduced plaque, gingivitis, and gingival bleeding on probing after 12 weeks as compared to the NC rinse. Both flossing interventions statistically significantly reduced interproximal gingivitis and gingival bleeding at 12 weeks compared to the NC rinse; neither flossing intervention significantly reduced interproximal plaque after 12 weeks compared to the NC rinse.Conclusions:Rinsing with a 4EO mouthrinse statistically significantly improved all oral health outcome measures at all time points compared to a NC rinse in this 12-week clinical trial. While professional and supervised flossing improved gingival health compared to use of the NC rinse, statistically significant plaque reduction with dental flossing was not attained at the end of the 12-week trial.

Habits, Practices and Beliefs Regarding Floss and Mouthrinse among Habitual and Non-Habitual Users.

Purpose:The purpose of this survey was to investigate how flossing and rinsing behaviors impact individual beliefs about oral disease risk, the efficacy of floss and mouthrinse, and the perceived benefits and barriers of floss and mouthrinse.Methods:Participants in this required component of a 12-week plaque and gingivitis randomized clinical trial on flossing and rinsing regimens completed a paper questionnaire prior to randomization and baseline/screening measurements.Results:All of the clinical trial participants (n=213) completed the questionnaire. Respondents were grouped as habitual or non-habitual users of floss or mouthrinse if the product was used at least once daily; 16% (n=34) were habitual users of floss and 17% (n=36) were habitual users of mouthrinse. Perceived barriers included fear of gingival bleeding and pain, forgetting, and not including flossing or rinsing as part of the daily oral care routine. Non-habitual users were less likely to believe in the intangible benefits of flossing or rinsing and much more likely to perceive barriers to using floss or mouthrinse. Risk perception of developing oral disease was not shown to predict product usage. Respondents viewed their risk of developing gingivitis as relatively low despite this diagnosis being confirmed clinically among the participants.Conclusions:While respondents strongly believed that brushing, flossing, and mouthrinse use carry unique benefits and that combining all three methods would be optimal, these respondents still had high perceived barriers to using floss and mouthrinse regularly and consequently these habits were not included in their daily oral hygiene regimen. Understanding the perceptions regarding oral health behaviors may help drive more effective interventions and assist practitioners in improving their patients' oral health outcomes.

Potassium oxalate mouthrinse reduces dentinal hypersensitivity: A randomized controlled clinical study.

BACKGROUND: Dentinal hypersensitivity is a prevalent oral condition that can be treated with in-office application of potassium oxalate (KO), which has US Food and Drug Administration 510(k) clearance. In this study, the authors assessed a KO mouthrinse for home use. The authors evaluated clinically meaningful improvement by analyzing the proportions of participants who responded to treatment. METHODS: In this multicenter, double-blind, parallel-group controlled study, the authors randomly assigned 375 participants with dentinal hypersensitivity to 1 of 2 mouthrinse groups: KO (189 participants) and placebo (186 participants). Participants used their assigned mouthrinses for 4 weeks. Each participant's success (defined as a ≥ 30% reduction from baseline in mean cold air stimulus response) was the primary efficacy measurement. The authors further defined success, on the basis of 2012 criteria from the American Dental Association, as a statistically significant difference of 20% or more between experimental and placebo groups for 1 sensitivity index. RESULTS: KO mouthrinse had statistically significantly higher success rates (the primary efficacy measurement) than did placebo (69.3% versus 44.6%; estimated odds ratio [OR], 2.817; 95% confidence interval [CI], 1.843 to 4.307; P < .001). At week 4, KO had statistically significant improvements compared with placebo in cold air stimulus score (estimated difference, -14.27 millimeters; 95% CI, -18.68 to -9.87; 35.6% improvement; P < .001) and tactile sensitivity (estimated difference, 13.45 grams; 95% CI, 9.83 to 17.08; 88.0% improvement; P < .001). The authors also observed statistically significant improvements for KO at week 2. Cold air stimulus and tactile sensitivity scores at weeks 2 and 4 were secondary efficacy measurements. CONCLUSIONS: This study's results demonstrated that KO mouthrinse used as an adjunct to toothbrushing statistically and clinically significantly controlled and reduced dentinal hypersensitivity. PRACTICAL IMPLICATIONS: Clinicians can use these results when determining appropriate at-home care regimens for patients with hypersensitivity.

The effects of essential oil mouthrinses with or without alcohol on plaque and gingivitis: a randomized controlled clinical study.

BACKGROUND: The efficacy of several variants of essential oil mouthrinses has been studied extensively. This is the first study to compare the anti-plaque and anti-gingivitis efficacy of two marketed essential oil mouthrinses: one is an alcohol containing mouthrinse and the other one is an alcohol-free mouthrinse. METHODS: This examiner-blind, parallel-group study randomized subjects to three groups: 1) Mechanical Oral Hygiene (MOH) only; 2) MOH plus Alcohol-Containing essential oil Mouthrinse (ACM); 3) MOH plus Alcohol-Free essential oil Mouthrinse (AFM). Primary endpoint was whole-mouth mean Modified Gingival Index (MGI) at six months. Secondary endpoints included whole-mouth mean MGI at one and three months, and whole-mouth mean Plaque Index (PI) and whole-mouth mean Bleeding Index (BI) at one, three and six months. Safety assessments were conducted at all time points. RESULTS: A total of 370 subjects were enrolled; 348 subjects completed the study. After six months, subjects using essential oil mouthrinses with or without alcohol showed significant reduction (p < 0.001) in gingivitis (28.2% and 26.7%, respectively) and significant reduction (p < 0.001) in plaque (37.8% and 37.0%, respectively), compared to those performing MOH only. Significant reductions in MGI, PI, and BI (p < 0.001) were observed at one and three months and also at six months for mean BI. No statistically significant differences were observed for all measured indices between ACM and AFM groups at any time point. Both mouthrinses were well tolerated. CONCLUSIONS: No significant differences were observed in the efficacy of ACM and AFM to reduce plaque and gingivitis, when used in addition to MOH, over six months. TRIAL REGISTRATION: The trial was registered on clinicaltrials.gov on November 30, 2016. The registration number is NCT02980497 .

Meta-analysis of the effect of an essential oil-containing mouthrinse on gingivitis and plaque.

BACKGROUND: Standard recommendations for oral hygiene practices have focused on mechanical methods (toothbrushing and interdental cleaning). Published evidence indicates antimicrobial mouthrinses provide oral health benefits beyond mechanical methods alone. The purpose of this meta-analysis was to evaluate the combined effectiveness of mechanical methods with essential oil-containing mouthrinses (MMEO) versus mechanical methods (MM) alone in achieving site-specific, healthy gingival tissue and reducing plaque and gingivitis. TYPES OF STUDIES REVIEWED: All industry-sponsored clinical trials investigating the antigingivitis and antiplaque effects of essential oil (EO)-containing mouthrinses conducted from 1980 to 2012 were reviewed; 29 of 32 studies met the inclusion criteria of 6 months or longer duration, randomized, observer-masked, placebo-controlled, and with individual-level site-specific data. By-study treatment effects were estimated through generalized linear models for binary data and analysis of covariance for continuous data, and then combined using standard meta-analysis techniques; heterogeneity was also assessed. RESULTS: Summary odds ratios for a healthy gingival site and for a plaque-free site were, respectively, 5.0 (95% confidence interval [CI], 3.3-7.5) and 7.8 (95% CI, 5.4-11.2) for MMEO participants versus MM participants at 6 months. The summary percentage reductions in whole-mouth mean gingivitis and plaque at 6 months were 16.0 (95% CI, 11.3-20.7) and 27.7 (95% CI, 22.4-32.9), respectively. Responder analyses using aggregate individual-level data showed 44.8% of MMEO participants and 14.4% of MM participants achieved at least 50% healthy sites in their mouths at 6 months. Similarly, 36.9% of MMEO participants and 5.5% of MM participants achieved at least 50% plaque-free sites in their mouths at 6 months. CONCLUSIONS AND PRACTICAL IMPLICATIONS: This is the first meta-analysis to demonstrate the clinically significant, site-specific benefit of adjunctive EO treatment in people within a 6-month period (that is, between dental visits).

Impact of an anticaries mouthrinse on in vitro remineralization and microbial control.

Objective. The objective of this research was to evaluate the caries control potential of a new fluoride mouthrinse that also contained antimicrobial agents and a biofilm disrupting agent using different in vitro models. Methods. Four in vitro studies were conducted to assess the performance of this three pronged approach to caries control: (1) traditional enamel fluoride uptake, (2) surface microhardness study using pH cycling model and subsequent fluoride uptake, (3) a salivary biofilm flow-through study to determine the anti-microbial activity, and (4) a single species biofilm model measuring effect on biofilm matrix disruption. Results. The data showed that a LISTERINE rinse with fluoride, essential oils and xylitol was superior in promoting enamel fluoride uptake and in enhancing antimicrobial activity over traditional commercially available fluoridated products. An increase of the surface microhardness was observed when the LISTERINE rinse was used in combination with fluoridated toothpaste versus the fluoridated toothpaste alone. Finally, it was demonstrated that xylitol solutions disrupted and reduced the biovolume of biofilm matrix of mature Streptococcus mutans. Conclusion. These in vitro studies demonstrated that a fluoride mouthrinse with antimicrobial agent and biofilm matrix disrupting agent provided multifaceted and enhanced anti-caries efficacy by promoting remineralization, reducing acidogenic bacteria and disrupting biofilm matrix.

Randomized trial of the clinical efficacy of a potassium oxalate-containing mouthrinse in rapid relief of dentin sensitivity.

OBJECTIVE: The aim of this randomized clinical trial was to evaluate the efficacy of a mouthrinse containing 1.4% potassium oxalate (Listerine Advanced Defence Sensitive; LADS) plus Colgate Cavity Protection Regular toothpaste, in reducing dentin sensitivity. METHODS: This was an observer- and examiner-blinded, randomized, parallel-group, single-center, controlled, five-day clinical trial. Healthy adults were randomized (2:1:1) to LADS plus Colgate Cavity Protection Regular toothpaste, or to one of the two negative-control toothpastes alone: Crest Cavity Protection Regular or Colgate Cavity Protection Regular. The subjects carried out supervised and unsupervised brushing and rinsing twice a day. Dentin sensitivity was assessed at baseline and during treatment by Yeaple probe (tactile pressure; patient-reported discomfort by visual analogue scale [VAS]), as well as response to air blasts (VAS). RESULTS: All sensitivity assessments were similar at baseline in the 56 randomized subjects. By the third day, the Yeaple probe sensitivity scores for subjects treated with Colgate toothpaste plus LADS improved significantly compared to Crest toothpaste alone (p < 0.05). By the fifth day, the mean scores for subjects treated with Colgate toothpaste plus LADS were significantly improved compared with subjects treated with either toothpaste alone (p < 0.05). The other sensitivity assessments showed that Colgate toothpaste plus LADS achieved statistically significant improvements compared with Colgate and/or Crest toothpaste alone from the third day. CONCLUSIONS: The 1.4% potassium oxalate mouthrinse (LADS) was associated with a reduction in dentinal sensitivity within a five-day period. Statistically significant reductions in all sensitivity variables were achieved by Day 3 and even greater reductions in dentin sensitivity scores were observed after five days.

Randomised clinical efficacy trial of potassium oxalate mouthrinse in relieving dentinal sensitivity.

OBJECTIVE: The study aimed to determine the efficacy in relieving dentinal sensitivity of 4 weeks' treatment with an alcohol-free mouthrinse comprising 1.4% potassium oxalate (KO) (Listerine® Advanced Defence Sensitive; LADS), compared with negative and positive controls. METHODS: Subjects were randomised to one of three treatments: LADS mouthrinse - twice-daily toothbrushing with Crest® Cavity Protection Regular toothpaste, rinsing with water and then 10 mL LADS mouthrinse, followed by expectoration; negative control (twice-daily brushing with Crest Cavity Protection Regular toothpaste); or positive control (twice-daily brushing with Sensodyne® Original desensitising toothpaste). Dentine sensitivity was assessed at baseline and after 2 and 4 weeks by Yeaple probe (tactile pressure; patient-reported discomfort by visual analogue scale [VAS]), air blast (VAS) and global subjective sensitivity (VAS). Oral tolerance was monitored throughout the study. RESULTS: At 2 weeks, subjects treated with the positive control and LADS mouthrinse showed significant reductions (p<0.05) in sensitivity scores versus the negative control. At 4 weeks, sensitivity decreased by 110% in the positive-control subjects versus negative-control subjects (p<0.001); sensitivity decreased by 80% in subjects receiving LADS mouthrinse versus negative-control subjects (p<0.05). No serious treatment-related oral adverse events were reported. CONCLUSIONS: The positive control (Sensodyne Original) significantly reduced sensitivity compared with the negative control (Crest toothpaste alone), thus validating the study. The LADS mouthrinse (1.4% KO mouthrinse) significantly reduced sensitivity compared with the negative control, suggesting that LADS mouthrinse was responsible for the clinical effect observed. The treatments were well tolerated. CLINICAL SIGNIFICANCE: To our knowledge, this is the first randomised clinical study to demonstrate the efficacy of a KO-containing mouthrinse (LADS) in relieving dentinal sensitivity.

Long-term management of plaque and gingivitis using an alcohol-free essential oil containing mouthrinse: a 6-month randomized clinical trial.

PURPOSE: This 6-month, examiner-blind, single center, randomized, parallel group, controlled clinical trial compared the antiplaque/antigingivitis effects of an alcohol-free EO mouthrinse (LISTERINE Zero) to a negative control (5% flavored, colored hydroalcohol) and to an alcohol-free CPC-containing mouthrinse (Colgate Plax). METHODS: 337 gingivitis subjects were clinically examined to determine Modified Gingival Index (MGI) and Plaque Index (PI) at baseline, 3 and 6 months. The primary efficacy variables were mean MGI and mean PI at 6 months (statistically analyzed by ANCOVA). After professional dental prophylaxis, subjects were randomly assigned to 6-month twice daily unsupervised use of alcohol-free EO, alcohol-free CPC or a negative control rinse, in conjunction with normal brushing and flossing. Safety was monitored throughout the study. RESULTS: 311 subjects completed the study. After 6 months of use, EO significantly reduced plaque (31.6%) and gingivitis (24.0%) compared to negative control. At 6 months, CPC also significantly reduced plaque (6.4%) and gingivitis (4.4%) compared to negative control. EO provided a 26.9% decrease in plaque and a 20.5% decrease in gingivitis compared to CPC (P < 0.001). All rinses were well tolerated. The alcohol-free EO mouthrinse demonstrated superior efficacy in reducing plaque and gingivitis over 6 months compared to both negative control and alcohol-free CPC mouthrinse.

Antiplaque and antigingivitis efficacy of an alcohol-free essential-oil containing mouthrinse: a 2-week clinical trial.

PURPOSE: This randomized, examiner blind, parallel group, controlled clinical study evaluated the antiplaque and antigingivitis potential of an alcohol-free essential oils containing mouthrinse (Listerine Zero) compared to a 5% hydroalcohol mouthrinse (negative control), using a 2-week experimental gingivitis model. METHODS: 92 subjects, male and female, ranging in age from 18-68 years, in good general health, were assigned to one of the two treatment groups: Alcohol-free essential oils containing mouthrinse (LZ) or 5% hydroalcohol negative control (C) rinse. The mean Turesky Modification of the Quigley-Hein Plaque Index (PI) and the mean Modified Gingival Index (MGI) at 2 weeks were the primary efficacy endpoints. Following baseline examinations, subjects received a complete dental prophylaxis and began supervised rinsing with their assigned mouthrinse twice daily for 2 weeks, as their sole oral hygiene measure. RESULTS: 90 subjects completed the trial. At 2 weeks, LZ was more effective (P<0.001) than C in reducing plaque (23.9%) and gingivitis (10.4%).