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

Abstract

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.

Keywords: Dental plaque; Gingivitis; Periodontal diseases; Tin fluorides; Toothpastes.

Conflict of interest statement

AA and NP are employees of GSK Consumer Healthcare and AB was an employee of GSK Consumer Healthcare at the time of the study. Silverstone Research, of whom PA is an employee, has received funding from GSK Consumer Healthcare.

© 2021. The Author(s).

Figures

Fig. 1

Study flow. mITT modified intent to treat

Fig. 2

Mean Bleeding Index (BI) score ± standard error* (modified intent to treat population). *Raw mean at baseline (pre-prophylaxis); adjusted mean at Weeks 2 and 3 (post-prophylaxis following baseline assessment). BI score ranges from 0 (no bleeding at 30 s after probing) to 2 (immediate bleeding on probing)

Fig. 3

Mean number of bleeding sites ± standard error* (modified intent to treat population). *Raw mean at baseline (pre-prophylaxis); adjusted mean at Weeks 6 and 12 (post-prophylaxis following baseline assessment). BI score ranges from 0 (no bleeding at 30 s after probing) to 2 (immediate bleeding on probing); a site was considered as 'bleeding' if the BI score was 1 or 2

Fig. 4

Mean modified Gingival Index (MGI) score ± standard error* (modified intent to treat population). *Raw mean at baseline (pre-prophylaxis); adjusted mean at Weeks 6 and 12 (post-prophylaxis following baseline assessment). MGI score ranges from 0 (absence of inflammation) to 4 (severe inflammation)

Fig. 5

Mean overall and interproximal Turesky Plaque Index (TPI) score ± standard error* (mITT population). *Raw mean at baseline (pre-prophylaxis); adjusted mean at Weeks 6 and 12 (post-prophylaxis following baseline assessment). TPI score ranges from 0 (no plaque) to 5 (severe plaque covering two-thirds or more of the tooth crown)