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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., (© 2024. The Author(s).)

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., (© 2024. The Author(s).)

Background: Mouthrinses containing potassium salts have been shown to be effective for the relief of dentinal hypersensitivity (DH) when used adjunctively to toothbrushing with a nonsensitivity toothpaste., Methods: The authors conducted a randomized, 8-week, single-center, examiner-blinded, parallel-group clinical trial with 191 participants with DH. Participants were randomized to twice-daily use of either 3% potassium nitrate (KNO 3 ) mouthrinse plus fluoride toothpaste or the same fluoride toothpaste alone. The primary outcome was change from baseline in response to an evaporative (air) stimulus at 8 weeks, measured using the Schiff sensitivity scale. Secondary outcomes were response to an evaporative (air) stimulus with the Schiff sensitivity scale (4 weeks) and a visual rating scale (4 and 8 weeks) and response to a tactile stimulus (4 and 8 weeks)., Results: Both groups showed statistically significant improvements in evaporative (air) sensitivity from baseline after 4 and 8 weeks (P < .0001). At weeks 4 and 8, the authors observed significant improvements from baseline in tactile sensitivity only in the KNO 3 mouthrinse group (P < .0001). Between-treatment comparisons for all sensitivity measures at both time points showed statistically significantly greater DH reductions in the KNO 3 mouthrinse group compared with the toothpaste-alone group (P = .0004 for the visual rating scale at week 4; P < .0001 for all other measures and time points). Treatments were generally well tolerated., Conclusions: Twice-daily use of a 3% KNO 3 mouthrinse, adjunctive to toothbrushing with fluoride toothpaste, provided significant improvements in DH compared with fluoride toothpaste alone., Practical Implications: Addition of 3% KNO 3 mouthrinse to a typical oral hygiene regimen of toothbrushing with fluoride toothpaste provides an alternative strategy for the management of DH. ClinicalTrials.gov: NCT02226562., (Copyright © 2019 American Dental Association. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2018 American Dental Association. Published by Elsevier Inc. All rights reserved.)

Objectives: To evaluate effectiveness of oral rinses containing dipotassium oxalate monohydrate (KOX) in relieving dentinal hypersensitivity (DH) after 8 w use adjunctive to brushing., Methods: Three 8-week, randomised, controlled, double-blind, parallel-group, single-centre studies were conducted in adults with DH. In each study, participants were randomised to one of two experimental rinses or a placebo in a matrix design, such that each experimental rinse was evaluated in two studies. Rinses A (pH 4.5) and B (pH 7.0) contained 1.5% KOX and were fluoride-free; Rinse C (pH 4.5) contained 2.0% KOX and 45 ppm fluoride as NaF; the placebo rinse (pH 4.5) did not contain KOX or fluoride. Participants brushed with a fluoride dentifrice for 1 min, briefly rinsed with water, then rinsed with their assigned oral rinse for 1 min twice daily for 8 w. DH was assessed at baseline and following 4 and 8 w use by response to an evaporative (air) stimulus (evaluated by Schiff sensitivity score and a 10-point visual rating scale) and a tactile stimulus (Yeaple probe)., Results: All rinses in each study were associated with statistically significant improvements from baseline in measures of DH after 4 and 8 w treatment. However, between-treatment comparisons were inconsistent across the studies, with only Study 3 demonstrating a significant difference between the experimental (Rinses B and C) and placebo rinses. A number of treatment-related adverse events (all mild) were reported., Conclusions: Rinses containing 1.5-2.0% KOX did not consistently demonstrate a benefit over placebo in relieving DH after 8 w use., Clinical Significance: While favourable results were found in one of the investigations, this suite of studies shows that the possibility of inconsistent results exists even with the best designed and executed trials., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

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. [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: 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 12week 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. [ABSTRACT FROM AUTHOR]

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

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. [ABSTRACT FROM AUTHOR]