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 (CPC a , n = 39), 0.05% CPC alcohol-free (CPC na , 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.
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.
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.
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