Effectiveness of Oral Rinse as an Adjunct to Toothbrushing: A 6-Week Clinical Trial Management of Plaque and Gingivitis With Daily Oral Rinsing.

A common condition found in many patients, gingival inflammation results from irritation from dental plaque and the bacteria contained in plaque. Although effective management of dental plaque and the resulting gingivitis through daily homecare continues to be heavily emphasized, the high prevalence of oral diseases globally suggests that most individuals do not achieve sufficient plaque removal with their manual toothbrushing routine. To help enhance a patient's homecare regimen, daily oral rinsing has been shown to improve oral hygiene. The simple use of mouthwash after toothbrushing optimizes plaque removal while leading to an improvement in gingival health. This article reviews a single-center, randomized, controlled, single-blind, 6-week study designed to evaluate the safety and efficacy of a professional chlorhexidine alternative oral care mouthrinse as an adjunct to toothbrushing with sodium fluoride toothpaste with regard to plaque removal and gingivitis reduction.

Effects of stannous fluoride dentifrice on gingival health and oxidative stress markers: a prospective clinical trial.

BACKGROUND: Periodontal disease results in oral dysbiosis, increasing plaque virulence and oxidative stress. Stannous fluoride (SnF2) binds lipopolysaccharides to reduce plaque virulence. This study prospectively assessed SnF2 effects on oxidative stress in adults with gingivitis. METHODS: This was a 2-month, single-center, single-treatment clinical trial. Twenty "disease" (> 20 bleeding sites with ≥ 3 pockets 3 mm-4 mm deep) and 20 "healthy" (≤ 3 bleeding sites with pockets ≤ 2 mm deep) adults were enrolled. All participants were instructed to use SnF2 dentifrice twice daily for 2 months. An oral examination, Modified Gingival Index (MGI) examination and Gingival Bleeding Index (GBI) examination were conducted at baseline, 1 month and 2 months. Gingival crevicular fluid (GCF), saliva, oral lavage and supragingival plaque were collected at each visit to evaluate: Endotoxins, Protein Carbonyls, L-lactate dehydrogenase (LDH), Ferric reducing antioxidant power (FRAP), Oxidized low density lipoproteins (oxi-LDL), IL-6 and C-reactive protein (CRP). A subset-analysis examined participants considered at higher risk of cardiovascular disease. Change-from-baseline analyses within each group were of primary interest. RESULTS: The disease group showed statistically significant reductions in GBI at Month 1 (67%) and Month 2 (85%) and in MGI at Month 1 (36%) and Month 2 (51%) versus baseline (p < 0.001). At baseline, the disease group showed greater LDH in GCF and oxi-LDL levels in saliva versus the healthy group (p ≤ 0.01). Total antioxidant capacity (FRAP) in saliva increased versus baseline for the disease group at Months 1 and 2 (p < 0.05), and levels for the disease group were greater than the healthy group at both timepoints (p < 0.05). SnF2 treatment reduced endotoxins (lavage) for both disease and healthy groups at Month 2 (p ≤ 0.021) versus baseline. There was a reduction in oxidative stress markers, namely protein carbonyl in saliva, at Months 1 and 2 (p < 0.001) for both groups and a reduction in cytokine IL-6 (lavage) in the disease group at Month 2 (p = 0.005). A subset analysis of participants at higher coronary disease risk showed reductions in endotoxins in lavage, oxi-LDL, and CRP in saliva at Month 2 (p ≤ 0.04). CONCLUSION: SnF2 dentifrice use reversed gingival inflammation, suppressed endotoxins and reduced some harmful oxidant products in saliva and gingiva. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT05326373, registered on 13/04/2022.

A randomized crossover trial assessing denture adhesive for prevention of food infiltration among partial denture wearers.

PURPOSE: This two-treatment, four-period, double-blind, randomized controlled crossover trial assessed the ability of two denture adhesives, both applied with a thin nozzle in a continuous application pattern, to prevent food infiltration beneath partial dentures. METHODS: Participants with mandibular partial dentures and a history of food particle infiltration were enrolled. All participants used both an optimized calcium/zinc partial salt of polyvinyl methyl ether/maleic acid (PVM/MA) denture adhesive and a calcium/sodium partial salt of PVM/MA test denture adhesive, twice each, throughout four study periods, according to a randomly assigned sequence. At each visit, participants underwent two assessments: once with no denture adhesive (baseline) and once with denture adhesive, 1 hour after adhesive application. For each assessment, participants ate one-half of the top of a poppy seed muffin, and a dental professional counted the seeds retained on the denture and mucosa, which was the primary variable. The change-from-baseline comparison was made for each treatment separately using a paired t-test or Wilcoxon Signed Rank test depending on the normality of the data. A between-treatment comparison for the change from baseline was performed using a crossover ANCOVA with treatment and period as fixed effects and participant as a random effect. The baseline poppy seed count was used as a covariate. RESULTS: 30 participants were enrolled; 29 completed the trial. Both denture adhesives achieved statistically significantly fewer retained seeds versus baseline (P< 0.001). The calcium/zinc adhesive reduced the seed count from baseline by 85.9% (6.18 vs 0.86), and the calcium/ sodium adhesive reduced seed count by 76.6% (6.04 vs 1.43). Comparing the two denture adhesives, the reduction in seed count from baseline was statistically significantly greater for the calcium/zinc adhesive versus the calcium/sodium formulation (P= 0.008). CLINICAL SIGNIFICANCE: These results support the recommendation of denture adhesive use for the prevention of food infiltration beneath partial dentures, with optimized calcium/zinc denture adhesive showing the greatest prevention benefit.

Safety and Effectiveness of a Novel Color Corrector Serum for Causing Temporary Changes to Tooth Shade: A Randomized Controlled Clinical Study.

Tooth color is a major driver of facial esthetics. While permanent changes in tooth shade can be achieved by bleaching and restorations, there is a need for cosmetic products that can cause reversible color changes. This randomized controlled clinical study assessed the effectiveness and safety of a novel color-correcting product (Hismile™ V34 Color Corrector Serum™) versus a placebo (vehicle control lacking the color-change dyes). A single-center, randomized, controlled, examiner-blind, two-group, parallel design, single-use study design was followed. The test products were applied on a cotton bud for 30 s, and then, rinsed off. Tooth shade for maxillary central incisors was measured at baseline, immediately, and at 30 and 60 min, using the Vita Bleachedguide 3D-Master® Shade Guide and the EasyShade Advanced 4.0 spectrophotometer (for determining values of L*a*b*). The subjects (N = 60) had a baseline shade of 1M2 (rank 9) or darker. A single application of the test product resulted in an immediate and significant (p < 0.001) three shade improvement (26.2%) according to the shade guide, and the same significant benefits extended to 30 and 60 min. The placebo product did not alter tooth shade (p = 0.326). These changes were accompanied by significant improvements in the L value (whiteness) up to 30 min, and a reduction in b* (yellowness) for up to 60 min. Two-thirds of subjects using the test product stated in a survey that their teeth appeared both whiter and brighter. No safety issues arose from the use of the test product or vehicle control. These results indicate that using a color corrector can achieve worthwhile changes to tooth shade for up to 60 min.

A proof of principle investigation of a novel enzyme formulation on dental calculus deposition: a 4-week randomized human clinical trial.

BACKGROUND: The dissolution of dental calculus, safely and at home, is among the more challenging issues facing the over-the-counter healthcare industry. Pontis Biologics, Inc. has developed novel model of calculus development and structure and has formulated a dentifrice (Tartarase™) using digestive enzymes as active ingredients that is shown to dissolve dental calculus in this Proof of Principle clinical trial. METHODS: This investigation was designed to evaluate the safety and efficacy of a novel enzyme formulation to remove existing calculus deposits in 4 weeks, measured using the Volpe-Manhold Index (V-MI) on lingual surfaces of 6 lower anterior teeth. The test formulation was compared to Crest Cavity Protection, as a control dentifrice. A total of 40 randomized test subjects began the study with 20 assigned to the control dentifrice and 20 assigned to the Tartarase groups (ten each, one brushing with Tartarase twice daily and one brushed with Tartarase and wore a dental tray filled with Tartarase for 30 min then brushed again with Tartarase, once daily). RESULTS: The Crest group experienced a 12% increase in calculus, in contrast to the results of both Tartarase groups that experienced a 40% reduction in calculus in 4 weeks of unsupervised at home use of the Tartarase toothpaste formulation. CONCLUSIONS: This proof of principle study demonstrates that a dentifrice, formulated along the lines of the Tartarase material, is capable of combating calculus accumulation using the same oral hygiene habits that are common worldwide. TRIAL REGISTRATION: This trial was registered retrospectively at clinicaltrials.gov and has the Unique Identification Number: NCT06139835, 14/11/2023.

A Randomized, Parallel Design Study to Evaluate the Effects of Different Oral Cleaning Modalities on Gingivitis and Plaque After a 6-Week Period of Home Use.

The study objective was to evaluate the effect of different interdental oral cleaning modalities on gingivitis and plaque following a 6-week period of home use. This was a randomized, parallel, examiner-blinded study. Study subjects were routine manual toothbrush (MTB) users with moderate to severe gingivitis, aged 18 to 65 years. Subjects were required to have a gingival bleeding score of ≥1 on at least 50 gingival sites per the Gingival Bleeding Index (GBI) and to have a minimum average plaque score of ≥0.6 per the Rustogi Modified Navy Plaque Index (RMNPI) following a 3- to 6-hour plaque accumulation period. Subjects were randomly assigned to one of four groups based on the oral care cleaning modality: (1) NON group: MTB alone, (2) FLS group: MTB plus string floss, (3) MPF group: MTB plus a Philips® Sonicare® Power Flosser with the Quad Stream nozzle, or (4) PPF group: Philips Sonicare power toothbrush plus the power flosser. Safety and efficacy measures (Modified Gingival Index [MGI], GBI, and RMNPI) were assessed at baseline, 2 weeks, and 6 weeks. The primary efficacy endpoint was the reduction in gingival inflammation from baseline to week 6 as measured by the MGI. A total of 260 subjects were randomized and 256 subjects completed the study. The adjusted mean percent reduction in gingival inflammation from baseline to week 6 was 14.90% for the NON group, 13.16% for the FLS group, 33.51% for the MPF group, and 49.30% for the PPF group. Pairwise comparisons indicated that both the PPF and MPF groups were statistically significantly different from both the NON and FLS groups. In conclusion, use of either the Philips Sonicare power toothbrush with the Philips Sonicare Power Flosser or an MTB with the Philips Sonicare Power Flosser was statistically superior to an MTB alone and an MTB used with string floss in reducing gingival inflammation following 6 weeks of home use.

A Randomized, Parallel Design Study to Compare the Effects of Different Interdental Cleaning Modalities on Gingivitis and Plaque After a 6-Week Period of Home Use.

The objective of this study was to evaluate the effect of different interdental oral cleaning modalities on gingivitis and plaque following a 6-week period of home use. This was a randomized, four-arm, parallel design clinical trial. Study subjects were manual toothbrush (MTB) users with moderate to severe gingivitis, aged 18 to 65 years. Subjects were required at baseline to have a gingival bleeding score of ≥1 on at least 50 gingival sites per the Gingival Bleeding Index (GBI) and to have an overall plaque score of ≥0.6 per the Rustogi Modified Navy Plaque Index (RMNPI) following a 3- to 6-hour plaque accumulation period. Subjects were randomly assigned to use one of four oral care cleaning modalities: (1) NON group: MTB alone, (2) FLS group: MTB plus string floss, (3) IDB group: MTB plus an interdental brush, or (4) CPF group: MTB plus the Philips® Sonicare® Cordless Power Flosser with the Quad Stream nozzle. Efficacy measures (Modified Gingival Index [MGI], GBI, and RMNPI) and safety were assessed at baseline, 2 weeks, and 6 weeks. The primary efficacy endpoint was the reduction in gingival inflammation from baseline to week 6 as measured by the MGI. Of the 372 subjects randomized in the study, 364 completed a post-baseline MGI evaluation and were included in the analyses. The adjusted mean percent reduction in gingival inflammation from baseline to week 6 was -2.10% for the NON group, 2.82% for the FLS group, 2.60% for the IDB group, and 29.10% for the CPF group. Pairwise comparisons indicated that the CPF group was statistically significantly different from the NON, FLS, and IDB groups (.0001). In conclusion, adjunctive use of the Philips Sonicare Cordless Power Flosser with the Quad Stream nozzle and an MTB showed statistically better results in term of reducing gingival inflammation following 6 weeks of home use when compared to an MTB alone, an MTB used with string floss, and an MTB used with an interdental brush.

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.

The effects of scaling and root planing plus home oral hygiene maintenance in Stage I/II periodontitis population: A 24-week randomized clinical trial.

OBJECTIVES: To compare the effects of powered and manual toothbrushing following scaling and root planing on bleeding on probing and other clinical indicators of periodontitis. MATERIALS AND METHODS: This was a randomized, examiner-blind, parallel-design, 24-week clinical study. Eligible subjects were 18-75 years of age with Stage I or II periodontitis. All subjects received scaling and root planing (SRP) within 28 days of enrollment. Thereafter, subjects were randomized to twice daily at-home use of either a powered toothbrush (PTB) or a manual toothbrush (MTB). Randomization was balanced for gender and periodontitis stage. No other oral hygiene aids were permitted. Subjects were evaluated every 4 weeks for the following measures: bleeding on probing (BOP), surface plaque (MPI), probing pocket depth (PPD) and clinical attachment level until Week 24. RESULTS: Of 328 randomized subjects, 299 subjects completed the study. For BOP at Week 24, the Least Squares (LS) Mean, standard error (SE) reduction from baseline was 0.24 (0.01) for the PTB group and 0.02 (0.01) for the MTB group, resulting in a statistically significant treatment difference of 0.22 (0.01), p-value < 0.0001. There were also concomitant reductions in MPI and PPD at Week 24, resulting in statistically significant (p-value < 0.0001) LS Mean (SE) treatment differences of 0.86 (0.04) and 0.24 (0.01), for MPI and PPD, respectively. CONCLUSION: When combined with SRP, daily home oral hygiene maintenance including a powered toothbrush significantly reduced clinical symptoms of periodontitis and surface plaque levels compared to a manual toothbrush in a Stage I/II periodontitis population. (ClinicalTrials.gov Identifier: NCT04254770).

A randomized clinical study to assess the performance of a marketed denture adhesive in a model of food infiltration in healthy, edentulous adults.

OBJECTIVES: An optimized food infiltration methodology was utilized to assess the objective and subjective efficacy of a marketed denture adhesive regarding denture dislodgment and infiltration and perception of food particles under maxillary and mandibular dentures. A pilot study helped optimize methodologies before the efficacy study. MATERIALS AND METHODS: Participants were healthy adults (n =48 for both studies) with fair- to well-fitting and well-made full maxillary and mandibular dentures. In the pilot, groups were a denture adhesive applied in a conventional dabbed-on pattern, a denture adhesive applied in continuous strips, or no adhesive. In the efficacy study, groups were the Test denture adhesive (continuous strips pattern application) or no adhesive, employed in a crossover design. Food infiltration was investigated through measurement of peanut particle mass retrieved from under each denture (30-32 g chewed). No formal statistical testing was performed in the pilot. Statistical analysis in the efficacy study was performed using analysis of variance. Primary efficacy evaluation was combined peanut particle mass from both dentures. Secondary efficacy evaluations included peanut particle mass under separate dentures, participant-reported denture dislodgements, and awareness/rates of how bothersome peanut particles under dentures were. RESULTS: In the pilot, the median peanut particle mass was lower with either pattern application compared with no adhesive. In the efficacy study, peanut particle mass under combined dentures was lower with than without adhesive (geometric mean [product of values]: 5.56 vs. 29.13 mg) with a between-group geometric mean ratio (adhesive over no adhesive) of 0.19 (95% confidence interval: 0.12, 0.30) favoring the Test adhesive (p < .0001). Similar Test adhesive beneficial outcomes in both studies included significantly fewer denture dislodgements and awareness and how bothersome peanut particles under dentures were. Treatments were generally well-tolerated. CONCLUSIONS: These findings, including reduced peanut particle infiltration, fewer denture dislodgments, and lower ratings of bothersomeness, corroborate those studies investigating the benefits of denture adhesive in preventing food infiltration.

Clinical Assessment of Plaque Removal Using a Novel Dentifrice Containing Cellulose Microfibrils.

Dentifrice performance in the removal of dental plaque is influenced by the interactions of dentifrice components with tooth surfaces. This randomized controlled clinical study assessed the effectiveness and safety of a novel fluoride dentifrice formulation that included a micro-fibrillated cellulose network with entangled microcrystalline cellulose and silica particles (ProtegeraTM), and compared this to a positive control fluoride dentifrice (Crest Cavity Protection™). Whole mouth dental plaque levels in 82 healthy adults were measured after the first supervised use, and following a week of twice daily use at home. Overall, the test dentifrice was at least three times and up to four times more effective in whole-mouth plaque reductions, with a 38.6% reduction on first use, a 30.9% reduction at day 7, and a 41.6% reduction from day 1 to day 7, compared to reductions of 12.0%, 9.6% and 11.6%, respectively for the positive control, and up to seven times more effective in lingual plaque reductions, than the reference dentifrice (p < 0.001), with a 27.7% reduction on first use, a 22.3% reduction at day 7, and a 31.0% reduction from day 1 to day 7, compared to reductions of 4.4%, 2.2%, and 4.5%, respectively, for the positive control. No safety issues arose from the use of the test dentifrice. These results indicate that including micro-fibrillated cellulose enhances plaque removal effectiveness, without causing adverse changes to oral soft tissues.

Clinical Efficacy of the Oral Health System by Fresh Health Inc. in Adults on Gingivitis and Plaque in a 3-Arm, 30-Day Study as Compared to String Floss and Manual Brushing.

OBJECTIVE: To evaluate the safety and efficacy of the Oral Health System by Fresh Health Inc., used in conjunction with manual toothbrushing (Fresh + MTB) as compared to string floss and manual toothbrushing (floss + MTB) and manual toothbrushing (MTB) alone, as measured by clinical signs of gingivitis, plaque reduction, pocket depth, and bleeding. METHODS: One hundred ninety-two (192) generally healthy adults exhibiting signs of gingivitis completed this 30-day randomized, controlled, examiner-blinded, three-group parallel study design. All subjects were assigned a manual toothbrush and fluoride dentifrice, instructed to brush twice daily according to their normal habits, and provided with written and verbal instructions for all assigned products. Subjects in the control group used only the manual toothbrush and dentifrice. Subjects assigned to the string floss + MTB group were instructed to also floss once daily. Subjects assigned to the Fresh + MTB group were provided a Fresh Health Inc. custom-fit oral irrigator and instructed to use the device once daily with water for approximately 7 seconds in addition to toothbrushing. Gingivitis was assessed using the modified gingival index (MGI), bleeding on marginal probing was assessed via the gingival bleeding index (GBI), and plaque was measured using the Rustogi modified navy plaque index (RMNPI) at day 1, day 15, and day 30. Periodontal probing depth (PPD) and bleeding on probing (BOP) were measured at day 1 and day 30. Oral soft- and hard-tissue assessments were performed at all examination visits. RESULTS: There was no significant difference in age or sex between groups, and no significant difference in baseline MGI, GBI, RMNPI, BOP, and PPD values across groups. The Fresh + MTB group demonstrated statistically significantly better performance than the floss + MTB group and MTB group across all clinical indices at both 15 days and 30 days. At 30 days, the Fresh + MTB group showed a 40.9% improvement in whole-mouth MGI, which was significantly greater than the MTB and floss + MTB groups.

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.

Four-day plaque regrowth evaluation of a peptide chewing gum in a double-blind randomized clinical trial.

OBJECTIVE: Antimicrobial peptide, KSL-W, formulated as an antiplaque chewing gum (APCG), was tested to evaluate the dental plaque inhibition activity and safety in an IRB approved and FDA regulated 4-day plaque regrowth clinical study. METHODS: This Phase 2 two-armed placebo-controlled, double blind, randomized (1:1), multiple dose, and single-center study was evaluated in a proof of concept for the APCG containing 30 mg antimicrobial peptide KSL-W. Twenty six generally healthy subjects were consented and randomized into the study. The subjects were administered a dose three times per day for four treatment days following a complete dental prophylaxis. Participants were prohibited from conducting oral hygiene care (teeth brushing, flossing, and/or mouth wash rinse) for the duration of the trial. Twelve to 16 hr prior to the baseline visit, the subjects were to abstain from oral hygiene care. The Quigley-Hein Turesky plaque index (QHT) score and the oral soft tissue clinical exams were obtained at both Day 0 and Day 4. RESULTS: All randomized study subjects that received either APCG or placebo gum completed the study with no significant adverse events recorded. The APCG significantly inhibited the regrowth of dental plaque over the course of 4 days. The whole mouth data demonstrated a difference in the QHT between the APCG and the placebo gum of 1.14 (SE = 0.27) and 95% confidence bounds of 0.58, 1.70 with a two-tailed P value of .0003. CONCLUSION: Considering the limited sample size, the proof of concept analysis in this Phase 2 study confirmed that APCG is effective against dental plaque formation and safe for human use. (ClinicalTrials.gov Study ID# NCT02864901).

Safety and efficacy of a novel toothbrush utilizing RF energy for the reduction of plaque, calculus and gingivitis.

PURPOSE: To evaluate the safety and efficacy of the ToothWave radiofrequency (RF) toothbrush in the reduction of plaque, calculus and gingival inflammation, as compared to a standard powered toothbrush accepted by the American Dental Association (ADA). METHODS: This was a single-blind, double arm, prospective study. Subjects were randomized to one of two treatment groups, receiving either the RF powered toothbrush or a control powered toothbrush, and performing twice daily brushing for a test period of 6 weeks. Plaque (RMNPI), calculus (V-MI), gingival inflammation (MGI) and bleeding (GBI) were assessed at baseline, after 4 and 6 weeks. Comparisons were completed both within and between each treatment group. Statistical analyses were conducted using the Mann Whitney non-parametric model. RESULTS: 85 subjects completed the study and had fully evaluable data. No significant differences between the groups were found in the baseline scores (P≥ 0.165). Following 6 weeks, the RF test group demonstrated statistically significant reductions in plaque, gingivitis and calculus compared to the control powered toothbrush (P≤ 0.001). Both toothbrushes were well-tolerated and no device-related adverse events were reported. The RF-utilizing powered toothbrush produced statistically significant reductions in dental plaque, calculus deposition, gingival inflammation and gingival bleeding as compared to a control powered toothbrush. CLINICAL SIGNIFICANCE: The RF powered toothbrush used twice daily resulted in an overall improvement in oral health.