A randomised clinical study investigating efficacy of a stannous fluoride toothpaste in improving gingival health after 3 weeks' use.

BACKGROUND: This examiner-blind, stratified, parallel study aimed to evaluate the anti-gingivitis efficacy of a non-aqueous (anhydrous) 0.454% w/w stannous fluoride toothpaste ('Test') versus a sodium monofluorophosphate toothpaste ('Control') in people with clinically-confirmed mild-moderate gingivitis. Plaque-induced gingivitis can progress to irreversible periodontitis if left untreated. This can be controlled by an effective oral hygiene regimen such as one including toothbrushing with a toothpaste containing the chemotherapeutic agent stannous fluoride. Long-term studies over 4-12 weeks have shown the efficacy of stannous fluoride; however, shorter term studies are needed to examine if the effects on measures of gingivitis and plaque control occur sooner. METHODS: Eligible participants were randomised to 3 weeks' twice-daily brushing (for 1 min) with Test or Control toothpastes. The primary efficacy variable was between-treatment difference in Bleeding Index (BI) at 3 weeks; secondary variables were between-treatment differences in number of bleeding sites, modified Gingival Index (MGI), and Turesky modification of the Quigley-Hein Plaque Index (TPI) at Weeks 2 and 3. RESULTS: A statistically significant (p < 0.0001) lower BI score was reported for Test (n = 65) versus Control (n = 65) groups at Week 2 (mean difference: - 0.07 [95% CI - 0.9, - 0.05]; 32.7% difference) and Week 3 (mean difference: - 0.06 [95% CI - 0.8, - 0.04]; 29.2% difference). The Test group also demonstrated statistically significant lower (all p < 0.0001 versus Control) number of bleeding sites (Weeks 2/3 mean difference [95% CI]: - 10.04 [- 12.3, - 7.5]/ - 8.2 [- 11.1, - 5.3] sites; 33.0%/29.3% difference); MGI score (Weeks 2/3 mean difference [95% CI]: - 0.09 [- 0.13, - 0.06]/ - 0.10 [- 0.14, - 0.06]; 4.3%/4.7% difference); overall TPI score (Weeks 2/3 mean difference [95% CI]: - 0.45 [- 0.55, - 0.35/ - 0.42 [- 0.53, - 0.30] difference; 16.0%/15.1% difference) and interproximal TPI score (Weeks 2/3 mean difference [95% CI]: - 0.42 [- 0.52, - 0.30]/ - 0.41 [- 0.52, - 0.29]; 14.6%/14.1% difference). Both toothpastes were generally well tolerated. CONCLUSION: Three weeks' twice-daily brushing with the 0.454% w/w stannous fluoride Test toothpaste compared to the Control toothpaste led to statistically significant lower gingival bleeding, gingival inflammation and plaque levels in adults with mild-moderate gingivitis. These results indicate that plaque and gingivitis-reducing benefits of 0.454% w/w stannous fluoride may be seen from 2 weeks' use. Trial registration ClinicalTrials.gov Identifier: NCT04050722; 08/08/2019.

Rapid Antigingivitis Efficacy of a Novel Stannous Fluoride Dentrifice: Results from a 12-Week Randomized Controlled Clinical Trial.

OBJECTIVE: To assess the anti-gingivitis and anti-plaque efficacy of a novel bioavailable stannous fluoride (SnF2) dentifrice to a negative control. METHODS: This was a 12-week randomized, controlled, double-blind, two-treatment, parallel group clinical study. One hundred generally healthy adults with evidence of plaque and gingivitis were enrolled into the study. Subjects were randomly assigned to one of two dentifrice treatments: (1) novel SnF2 dentifrice containing the amino acid glycine as a stabilizing chelant (Procter and Gamble) or (2) a negative control sodium monofluorophosphate dentifrice. Gingivitis was assessed using the Löe-Silness Gingivitis Index (LSGI) at baseline, Week 1, and Week 12 while plaque was evaluated according to the Turesky Modification of the Quigley-Hein Plaque Index at baseline and Week 12. RESULTS: One hundred subjects completed the trial. Subjects using the novel SnF2 dentifrice demonstrated statistically significantly fewer bleeding sites and a lower LSGI score versus those using the negative control as early as Week 1 (P less than .001). The benefit increased throughout the study, with the SnF2 dentifrice showing 33.4% fewer bleeding sites and a 16.5% lower LSGI score versus the negative control at Week 12 (P less than .001). Subjects with localized or generalized gingivitis (≥10% bleeding sites) had 6 times better odds of transitioning to generally healthy (less than 10% bleeding sites) after using the SnF2 dentifrice for 12 weeks versus the negative control. Plaque scores for the SnF2 dentifrice were also statistically significantly lower (P less than .001) than those for the negative control at Week 12. CONCLUSION: The novel SnF2 dentifrice with the amino acid glycine produced statistically significant improvements in gingival health that were seen as early as 1 week and numerically increased throughout the study.

Efficacy of a dissolvable strip with calcium sodium phosphosilicate (NovaMin®) in providing rapid dentine hypersensitivity relief.

OBJECTIVE: To evaluate the efficacy of a dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) (Novamin®) in providing rapid relief from dentine hypersensitivity (DH). METHODS: In this examiner-blind, proof-of-principle study, 120 healthy adults with DH were randomized 1:1 to the Test strip, professionally applied to facial surfaces of two selected teeth, or to No treatment. Sensitivity was assessed at baseline and 10min, 2h and 4h post-application in response to evaporative (air) and tactile stimuli (measured by Schiff sensitivity scale/a numeric rating scale and tactile threshold, respectively). Change from baseline was analyzed by ANCOVA. RESULTS: At 10min post-application, mean Schiff score change from baseline (primary endpoint) was statistically significant with the Test strip (-0.46; 95% confidence intervals [CI]: -0.563, -0.356; p<0.0001) but not with No treatment (-0.02; 95% CI: -0.119, 0.088; p=0.7664). The between-treatment group difference favored the Test strip (difference: -0.44; 95% CI: -0.591, -0.297; p<0.0001). Similar improvements with the Test strip were reported for all other evaporative (air) and tactile sensitivity endpoints (p<0.0001 vs no-treatment) at all timepoints (10min, 2h, 4h). Test strips were considered by most staff and participants slightly/moderately easy to apply (98%). Many participants rated the overall usage experience as "like moderately" (40%) or "like extremely" (20%). There were no treatment-related adverse events. CONCLUSION: This new CSPS-based technology may provide a novel treatment option for rapid relief from DH (Clinicaltrials.gov NCT02937623). CLINICAL SIGNIFICANCE: A dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) demonstrated significantly greater dentine hypersensitivity reductions following a single application compared with no treatment. Strips were well-liked by participants and generally well tolerated. A strip containing CSPS, which dissolves within 10min, may provide rapid relief from dentine hypersensitivity.

Efficacy and Tolerability of Sodium Bicarbonate Toothpaste in Subjects with Gingivitis: A 6-Month Randomized Controlled Study.

PURPOSE: Sodium bicarbonate (NaHCO3) in toothpaste can enhance the removal of biofilms involved in the development of gingivitis. To examine this over an extended time period, this study compared the efficacy and tolerability of twice-daily brushing for 24 weeks with 67% or 0% NaHCO3-containing toothpastes in subjects with moderate gingivitis. MATERIALS AND METHODS: 247 adults with bleeding after brushing and ≥ 20 gingival bleeding sites were randomized to twice-daily brushing with a 67% NaHCO3 or 0% NaHCO3 toothpaste. The primary efficacy variables were between-treatment differences in number of bleeding sites and the Modified Gingival Index (MGI) score after 24 weeks' use. Secondary efficacy variables included Bleeding Index (BI) and Turesky modification of Quigley-Hein Plaque Index (TPI) (overall and only interproximal sites). RESULTS: The 67% NaHCO3 toothpaste produced statistically significant improvements compared with the 0% NaHCO3 toothpaste in number of bleeding sites (-17.5; 95% CI -20.32, -14.66; p < 0.0001) and MGI score (-0.2; 95% CI -0.24, -0.17; p < 0.0001) at week 24. These significant differences were also found at 6 and 12 weeks for these measures and at 6, 12, and 24 weeks for BI and TPI scores (including at only interproximal sites) (all p < 0.0001). No treatment-related adverse events were reported. CONCLUSION: Twice-daily brushing with 67% NaHCO3 toothpaste was generally well tolerated and significantly improved indices of gingival bleeding and plaque compared with 0% NaHCO3 toothpaste in subjects with moderate gingivitis.

Randomized controlled trial evaluating concurrent gingivitis and stain effects of a two-step dentifrice/gel sequence.

PURPOSE: A randomized controlled trial was conducted to evaluate the clinical efficacy of a two-step dentifrice/whitening gel oral hygiene sequence on natural gingivitis and extrinsic stain. METHODS: The population consisted of healthy adults with clinical evidence of gingivitis and extrinsic stain. Consent, demographic information and clinical measurements were collected, after which subjects were randomized to treatment. Eligible subjects were dispensed blinded test kits containing over-labeled two-step 0.454% SnF2 dentifrice then 3% H2O2 whitening gel sequence or a regular 0.76% NaMFP dentifrice control (Colgate Cavity Protection), plus a regular soft manual toothbrush and instructions for use. Efficacy was assessed blind-to-treatment using the Gingivitis Bleeding Index (GBI) measured whole-mouth and the composite Lobene Stain Index (LSI) measured on the anterior dentition. Treatments were compared at Week 1 and Week 3 versus baseline for ΔGBI and ΔLSI using a two-sided 5% level of significance. RESULTS: A total of 61 subjects with a mean (SD) age of 33.4 (12.0) years were enrolled. Overall baseline means (SD) were 0.16 (0.05) for GBI and 1.30 (0.94) for LSI. After 1 week, only the two-step 0.454% SnF2 dentifrice then 3% H2 O2 whitening gel sequence demonstrated significant (P< 0.0001) reductions in both gingivitis and stain. Adjusted means for the changes with the dentifrice/gel sequence and control were -0.055 and -0.001 for ΔGBI, and -0.619 and -0.095 for ΔLSI, with groups differing significantly (P< 0.0001) on gingivitis and stain improvement. Outcomes at Week 3 were generally similar, with groups differing on bleeding and stain. Treatments were generally well-tolerated. CLINICAL SIGNIFICANCE: In a randomized controlled trial, use of a two-step 0.454% SnF2 dentifrice then 3% H2 O2 whitening gel sequence yielded concurrent improvements in gingivitis and stain compared to regular oral hygiene.

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.

A 12-week randomized clinical study investigating the anti-gingivitis efficacy of a 0.454% w/w stannous fluoride dentifrice.

PURPOSE: To evaluate and compare gingival health, as measured by a bleeding index (BI), a modified gingival index (MGI), number of bleeding sites, and blood in expectorate following twice daily use of a non-aqueous 0.454% weight/weight (w/w) stannous fluoride dentifrice ('Test dentifrice') compared to a sodium monofluorophosphate (SMFP) dentifrice (' Negative Control') over 12 weeks, in subjects with moderate gingivitis and gingival bleeding following tooth brushing. METHODS: This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 12-week clinical study in healthy adult volunteers with moderate gingivitis who demonstrated gingival bleeding following tooth brushing. Subjects were assessed at baseline for MGI, visible blood in dentifrice expectorate and BI. Following randomization, eligible subjects underwent a thorough dental prophylaxis and flossing. After 4 and 12 weeks of twice daily brushing with their allocated treatment, subjects returned to the site for MGI, visible blood in dentifrice expectorate, and BI assessments. RESULTS: Of 317 screened subjects, 253 were randomized, and 238 completed the study. Statistically significant differences between treatments were observed in favor of the Test dentifrice compared to the Negative Control dentifrice in terms of gingival bleeding (number of bleeding sites and bleeding index), and visual signs of gingival inflammation (MGI) (P< 0.0001 at Weeks 4 and 12 for all). The visual assessment of the level of blood in expectorate following brushing demonstrated large reductions from baseline, however no significant difference between treatments was observed. Treatments were generally well tolerated. CLINICAL SIGNIFICANCE: Use of a dentifrice containing 0.454% w/w stannous fluoride led to significantly greater control of gingivitis (gingival bleeding and visual signs of gingival inflammation) compared to a SMFP dentifrice over a 12-week period. This study was conducted in subjects with moderate gingivitis and in a population represented by individuals who experience gingival bleeding on brushing, and is therefore considered representative of individuals who may opt for treatment therapies in the form of a daily use toothpaste.

A 24-week randomized clinical study investigating the anti-gingivitis efficacy of a 0.454% w%#47;w stannous fluoride dentifrice.

PURPOSE: To evaluate and compare gingival health, as measured by a bleeding index (BI), a modified gingival index (MGI), a dental plaque index (PI), and number of bleeding sites following twice daily use of an anhydrous 0.454% weight/weight (w/w) stannous fluoride dentifrice (Test Dentifrice) compared to a sodium monofluorophosphate (SMFP) dentifrice (Negative Control) over 24 weeks. METHODS: This was a single-center, examiner-blinded, randomized [by gender and baseline mean MGI score (Low ≤ 2.00/High > 2.00)], stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent BI, MGI and PI assessments. Following randomization, eligible subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site with overnight plaque (having abstained from oral hygiene procedures for at least 8 hours) for BI, MGI and PI assessments. RESULTS: Of 109 screened subjects, 104 were randomized and 98 completed the study. Statistically significant differences between treatments were observed in favor of the Test Dentifrice compared to the Negative Control dentifrice for all outcome measures including not only BI, MGI and PI indices but also number of bleeding sites (P< 0.0001 at Week 12 and Week 24 for all). Data observation showed that the percentage of sites that decreased was more, and those that increased was less, with the Test Dentifrice than with the Negative Control dentifrice at both 12 and 24 weeks. Treatments were generally well tolerated. CLINICAL SIGNIFICANCE: Use of a dentifrice containing 0.454% w/w stannous fluoride led to significantly greater control of gingivitis (gingival bleeding and visual signs of gingival inflammation) and plaque compared to a SMFP dentifrice over a 24-week period.

A randomised exploratory clinical evaluation of dentifrices used as controls in dentinal hypersensitivity studies.

OBJECTIVES: To explore relative efficacy of six negative-control dentifrices utilised as controls in clinical studies compared with two dentine hypersensitivity (DH)-relief dentifrices used 2×/day for 8 weeks. METHODS: Six control dentifrices differing in terms of fluoride source (sodium fluoride/sodium monofluorophosphate), abrasive base (silica/dicalcium phosphate), relative dentine abrasivity (RDA) (∼17 to ∼180) and colour (white/blue/multicoloured stripes) were compared with a depolarising dentifrice (5% KNO3; RDA ∼70-97; 'Test 1') and an occlusion-technology dentifrice (0.454% SnF2; RDA ∼160-180; 'Test 2'). DH was assessed using tactile and evaporative (air) (measured by Schiff Sensitivity Scale and a visual rating scale [VRS]) stimuli. RESULTS: In total 249 subjects were randomized. All dentifrices yielded statistically significant improvements from baseline on all endpoints. The two DH-relief dentifrices ranked highest in terms of improvement in scores over the control dentifrices. While there was a clear differentiation between Test 1 and control dentifrices on both measures at 4/8 weeks, for Test 2, statistically significant improvements in Schiff scores were observed over all controls at Week 4 but only over three at Week 8. At Week 4 none of the controls separated from Test 2 on tactile threshold; all separated by Week 8. VRS scores did not separate test and control dentifrices. Dentifrices were generally well-tolerated. CONCLUSIONS: The six negative-control dentifrices can be used to assess dentifrices considered to be effective in reducing DH. Although response ranges for commercially available negative controls varied, these results may begin to set acceptable performance ranges for control dentifrices in DH trials.

Gingival Health and Plaque Regrowth Response Following a Four-Week Interdental Hygiene Intervention.

OBJECTIVES: To compare the efficacy of three adjunct interproximal cleaning methods versus a manual toothbrush alone on gingivitis, and demonstrate that the Philips Sonicare AirflossPro™ interproximal (IP) cleaning device provides a similar reduction in gingivitis and plaque compared to string floss. METHODS: A randomized, single-blind, parallel-design study was conducted on generally healthy adults exhibiting mild to moderate gingivitis. Eligible subjects were non-smokers, aged 18-65 years, with ≥ 0.5 per the Rustogi Modified Navy Plaque Index (RMNPI) and a Gingival Bleeding Index (GBI) of ≥ 1 on at least 10 sites. Eligible subjects were randomly assigned to use one of four oral hygiene regimens: manual toothbrush (MTB) alone; MTB plus string floss (SF); MTB plus Philips Sonicare AirflossPro used with Cool Mint Listerine® Antiseptic (AFPL); and MTB plus Philips Sonicare AirflossPro used with BreathRx™ (AFPB). Subjects were followed over a 28-day home-use period, with follow-up visits for efficacy and safety conducted at Days 14 and 28. All subjects were instructed to use the MTB twice daily and perform interproximal cleaning once daily, if assigned. Study efficacy endpoints included the Modified Gingival Index (MGI), Rustogi Modified Navy Plaque Index, and the Gingival Bleeding Index. RESULTS: Of 290 randomized subjects, 287 were followed to Day 14 and 286 were followed to Day 28. For the primary endpoint at Day 14, significantly larger reductions in MGI were observed in each of the three IP cleaning groups compared to MTB alone (p < 0.001). The adjusted mean reductions and standard error estimates (SE) for MGI expressed as a percent reduction from Baseline at Day 14 were: 0.22% (0.55%) for MTB; 4.30% (0.44%) for SF; 4.55% (0.45%) for AFPL; and 4.20% (0.44%) for AFPB. A non-inferiority test comparing AirflossPro to SF showed AirflossPro to be non-inferior to SF (p < 0.001). CONCLUSIONS: The addition of interproximal cleaning to manual tooth brushing statistically significantly reduces gingivitis and plaque compared to manual tooth brushing alone. Among the adjunct interproximal cleaning regimens, AirflossPro provides a similar reduction in gingivitis and plaque to string floss. All study regimens were safe on oral tissues.

Comparative Effects of 1.5% Oxalate Strips Versus 5% Potassium Nitrate Dentifrice on Dentin Hypersensitivity.

A randomized controlled trial was conducted to evaluate the safety and efficacy of a novel 1.5% oxalate sensitivity strip. Healthy adults with dentin hypersensitivity after a cool-air challenge were randomly assigned either three sensitivity strips (Crest® Sensi-Stop™ Strips, Procter and Gamble) plus regular toothpaste (experimental group) or 5% potassium nitrate dentifrice for twice-daily use (control group). First use was supervised, and response was measured immediately after first treatment and again 30 days later after direct provocation with air and tactile stimuli. A total of 79 subjects (mean age 37 years) were randomized and treated. After the first treatment, only the 1.5% oxalate strip group exhibited significant (P less than .0001) immediate sensitivity relief to both air and tactile stimulation. Repeated use improved response and, over 30 days, both treatments were effective. Between-group comparisons favored the episodic strips versus the daily-use dentifrice, with a majority of oxalate strip users having no measured air sensitivity at Day 30. Both treatments were well tolerated. A randomized clinical trial showed immediate and durable sensitivity relief for 1.5% oxalate strips and superior response when compared head-to-head versus a potassium nitrate dentifrice.

Early benefits with daily rinsing on gingival health improvements with an essential oil mouthrinse--post-hoc analysis of 5 clinical trials.

PURPOSE: The aim of this investigation through post-hoc analyses was to determine the ability to achieve gingival health in the short term with daily rinsing with an essential oil containing antimicrobial mouthrinse. METHODS: Conventional Analysis of Covariance (ANCOVA) on whole mouth mean plaque and gingivitis scores were originally conducted to demonstrate efficacy of adjunctive use of Cool Mint® LISTERINE® Antiseptic (EO) compared to negative control [brushing (B) or brushing/flossing (BF)] in each of 5 studies containing a 4 week evaluation. The Modified Gingival Index (MGI) was split into 2 categories: healthy (scores 0, 1) and unhealthy (≥2). Data, reflecting subjects that completed 4 weeks of treatment from 5 studies, were evaluated to determine the mean percent of healthy sites and mean percent of more inflamed "affected" areas (MGI≥3). RESULTS: At baseline, the mean percent healthy gingival sites ranged from 0.1 to 3.2%. At 4 weeks, up to 29.3% and 16.1% of sites were healthy for the EO group and negative control group, respectively. Three and 6 month data from 2 of the 5 studies resulted in up to 39.6% and 62% at 3 and 6 month mean percent healthy sites per subject for EO and up to 17.2% and 15.6% at 3 and 6 months, respectively, for negative control. Virtually plaque free sites (PI=0, 1) at 4 weeks ranged up to 34.3% and 8.1% for EO and control groups, respectively. CONCLUSION: Significantly more healthy gingival sites and virtually plaque free tooth surfaces can be achieved as early as 4 weeks with use of an essential oil antimicrobial mouthrinse. This finding continues through 6 months twice daily use as part of oral care practices compared to mechanical oral hygiene alone.

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.

Increasing antiplaque/antigingivitis efficacy of an essential oil mouthrinse over time: an in vivo study.

This randomized, observer-blind, parallel, controlled study determined the efficacy of an essential oils-containing (EO) antiseptic mouthrinse (in conjunction with toothbrushing) in reducing and/or controlling existing plaque or gingivitis over 6 months. Toothbrushing, combined with placebo rinsing, served as the control (C). Following ethics board approval (Biosci Research Canada, Ltd. Institutional Review Board), 139 healthy adults with mild to moderate plaque and gingivitis were randomized into EO or C groups. All subjects received oral/written instructions, monthly monitoring, and assigned unsupervised rinses. Efficacy variables were whole-mouth mean modified gingival index (MGI), Turesky modification of the Quigley Hein plaque index (PI), bleeding index (BI) at 6, 12, and 24 weeks, and data analysis through an analysis of covariance (ANCOVA) model. The EO group provided greater and increasing MGI, PI, and BI reductions than did C group over all examination periods. Compared to the C group, at 6, 12, and 24 weeks, MGI reductions for the EO group were 4.7%, 9.1%, and 20.4%, and PI reductions were 7.6%, 12.6%, and 26.3%, respectively. BI scores decreased over time and were significant compared to those for the C group (P < 0.001). Additionally, the percentages of sites improved versus baseline MGI over time for EO were 14.1%, 26.4%, and 43.3%, respectively. This study demonstrated that an EO-containing mouthrinse can provide an increasing benefit over a period of 6 months with twice daily use. This study also confirmed that an antiseptic EO rinse can provide a clinically significant benefit in reducing existing plaque and gingivitis.

Evaluation of anti-gingivitis benefits of stannous fluoride dentifrice among triclosan dentifrice users.

PURPOSE: To evaluate the anti-gingivitis benefits of a 0.454% highly bioavailable stannous fluoride dentifrice (SnF2) relative to a 0.3% triclosan/copolymer dentifrice (triclosan/copolymer) among triclosan/copolymer dentifrice users with residual gingivitis. METHODS: This was a randomized, controlled, double-blind, parallel group, 2-month clinical study. Self-reported triclosan/copolymer dentifrice users were recruited and provided with triclosan/copolymer dentifrice to use for 1 month. After this 1-month acclimation period, subjects who had residual gingivitis at the baseline visit were randomized to either the SnF2 dentifrice or the triclosan/copolymer dentifrice (positive control). Subjects performed their treatment unsupervised using their assigned dentifrice following manufacturers' usage instructions for 2 months. The Gingival Bleeding Index (GBI) and Modified Gingival Index (MGI) were used to measure gingivitis benefits at baseline and Month 2. An analysis of covariance was performed to compare treatment groups for the post-baseline scores as well as change from baseline, with the baseline score as a covariate. All comparisons were two-sided at the 0.05 level of significance. RESULTS: A total of 150 subjects were randomized to treatment. Both treatment groups experienced significant reductions in number of bleeding sites, gingival bleeding index (GBI), and gingival inflammation (MGI) relative to baseline (P < 0.001). At Month 2, the SnF2 dentifrice group demonstrated significantly lower adjusted mean scores versus the triclosan/copolymer group for number of bleeding sites, GBI, and MGI (P < 0.001). Between-treatment group comparisons for change from baseline values showed that the improvement in number of bleeding sites from baseline for the SnF2 group was 49% greater versus that of the triclosan/copolymer group (P < 0.001), and the GBI and MGI improvements from baseline for the SnF2 group were 48% and 37%, greater, respectively, relative to the triclosan/copolymer group (P < 0.001).

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%).

Randomized controlled trial of 0.454% stannous fluoride dentifrice to treat gingival bleeding.

PURPOSE: To evaluate the effects of a highly bioavailable 0.454% stannous fluoride dentifrice on established gingival bleeding over a 3-month period. MATERIALS AND METHODS: A randomized controlled clinical trial was conducted. In total, 100 adults with mild-to-moderate gingivitis and an average of 15 bleeding sites were assigned to either the stannous fluoride or regular control pastes for at-home use. Of these, 99 received study treatment and 97 completed the study. RESULTS: The stannous fluoride group experienced 50% to 74% reductions in bleeding sites relative to baseline or the control, differing significantly (P < 0.001) at all time points. Most subjects in the stannous fluoride group (94%) had measured improvements in bleeding, and nearly one half completed treatment with one or no bleeding sites. CONCLUSION: These study results suggest that incorporation of this 0.454% stannous fluoride dentifrice into daily oral hygiene maybe expected to yield less gingival bleeding at subsequent dental check-ups, and therefore reduce the risk of progressive periodontal disease.

Comparative antiplaque and antigingivitis efficacy of three antiseptic mouthrinses: a two week randomized clinical trial.

The objective of this randomized, examiner blind, parallel group, controlled clinical trial was to compare the antiplaque and antigingivitis efficacy of an essential oil-containing mouthrinse (EO) to two mouthrinses containing 0.05% Cetylpyridinium Chloride (CPC), one with alcohol and one alcohol-free, using a two-week experimental gingivitis validated-model with a 5% hydroalcohol rinse serving as the negative control. One hundred and fifty-nine subjects, 56 males and 103 females; ranging in age from 18 to 58 years in good general health were assigned to one of the four treatment groups: EO (n = 40), 0.05% CPC with alcohol (CPCa, n = 39), 0.05% CPC alcohol-free (CPCna, n = 40), and 5% hydroalcohol negative control (n = 40). The Mean Turesky Modification of the Quigley-Hein Plaque Index (PI) and the Mean Modified Gingival Index (MGI) were the primary efficacy endpoints and were evaluated at baseline and at two weeks. Following baseline examinations, subjects received a complete dental prophylaxis and began supervised rinsing with their assigned mouthrinse twice daily for two weeks, as their sole oral hygiene measure; 151 subjects completed the trial. Two weeks after baseline the EO adjusted mean PI and MGI scores were significantly lower than those of both CPC rinses and negative control (p < 0.001). In conclusion, the EO mouthrinse demonstrated significantly greater antiplaque and antigingivitis efficacy than both CPC-containing mouthrinses and the negative control.

Comparative antiplaque and antigingivitis efficacy of three antiseptic mouthrinses: a two week randomized clinical trial

The objective of this randomized, examiner blind, parallel group, controlled clinical trial was to compare the antiplaque and antigingivitis efficacy of an essential oil-containing mouthrinse (EO) to two mouthrinses containing 0.05 percent Cetylpyridinium Chloride (CPC), one with alcohol and one alcohol-free, using a two-week experimental gingivitis validated-model with a 5 percent hydroalcohol rinse serving as the negative control. One hundred and fifty-nine subjects, 56 males and 103 females; ranging in age from 18 to 58 years in good general health were assigned to one of the four treatment groups: EO (n = 40), 0.05 percent CPC with alcohol (CPCa, n = 39), 0.05 percent CPC alcohol-free (CPCna, n = 40), and 5 percent hydroalcohol negative control (n = 40). The Mean Turesky Modification of the Quigley-Hein Plaque Index (PI) and the Mean Modified Gingival Index (MGI) were the primary efficacy endpoints and were evaluated at baseline and at two weeks. Following baseline examinations, subjects received a complete dental prophylaxis and began supervised rinsing with their assigned mouthrinse twice daily for two weeks, as their sole oral hygiene measure; 151 subjects completed the trial. Two weeks after baseline the EO adjusted mean PI and MGI scores were significantly lower than those of both CPC rinses and negative control (p < 0.001). In conclusion, the EO mouthrinse demonstrated significantly greater antiplaque and antigingivitis efficacy than both CPC-containing mouthrinses and the negative control.