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.

Interactions and effects of a stannous-containing sodium fluoride dentifrice on oral pathogens and the oral microbiome

“…At present, good oral hygiene practices, such as regular toothbrushing with a dentifrice that contains active agents that control bacterial growth and accumulation (e.g., metal fluorides, quaternary ammonium compounds), are an effective way to maintain good oral health and prevent caries and periodontal diseases ( Rajendiran et al, 2021 ). One such functional agent is Stannous Fluoride (SnF 2 ), which has been extensively studied for its superior anti-caries effect and ability to reduce gingival inflammation and plaque in clinical settings ( Makin, 2013 ; Biesbrock et al, 2019 ; Clark-Perry and Levin, 2020 ; Parkinson et al, 2020 ; Acherkouk et al, 2021 ; He et al, 2021 ). As an anti-caries agent, SnF 2 provides protection by preventing demineralization of the tooth enamel and reducing plaque ( Wefel et al, 2002 ; Stookey et al, 2004 ).…”

Antibacterial and anti-inflammatory effects of a novel herb-mediated nanocomposite mouthwash in plaque-induced gingivitis: A randomized controlled trial

“…The long-term use of CHX-containing drugs, despite their effectiveness in lowering the microorganism levels in the oral cavity, is associated with local side effects, such as impaired taste, tooth staining, increased supragingival calculus production, and intermittent inflammation and desquamation of mucous membranes. 5 Herbal compounds have been included as ingredients in oral care products for a long time, especially in South Asian nations. Sanguinary, clove, propolis, miswak, neem, and charcoal are the most common herbal compounds included in toothpastes and mouthrinses.…”