Clinical Study 300178
Research type
Research Study
Full title
A 4-Week Randomised, Controlled, Examiner-blind, Clinical Study Investigating the efficacy of an Experimental Toothpaste containing Stannous Fluoride in improving gingival health
IRAS ID
346292
Contact name
Praveen Sharma
Contact email
Sponsor organisation
Haleon (UK)
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 28 days
Research summary
Gingivitis is a reversible inflammation of the periodontal tissues surrounding the tooth in response to the presence of dental plaque. It is reported to have a high prevalence worldwide in large population surveys but is also largely preventable. Left untreated, it is the main cause of tooth loss and considered one of the main threats to oral health. Gingivitis is in fact a pre-requisite for periodontitis (an irreversible severe inflammatory gum condition and major cause of tooth loss); while not all individuals with gingivitis go on to develop periodontitis, management of gingivitis is the primary measure employed in the prevention of this periodontal disease. The prevalence of periodontitis has remained largely unchanged over the last 25 years and the evidence-base shows periodontitis has associations with certain non-communicable diseases.
Anti-microbial agents have been incorporated into toothpastes for many years with a view to enhancing plaque control and associated periodontal benefits. Their addition to toothpaste formulations complements mechanical plaque removal by helping to reduce/inhibit the growth of bacterial plaque in areas of the mouth less accessible to toothbrushing, and by helping to prevent/slow subsequent re-colonization of ‘cleaned’ surfaces by the plaque bacteria
The Stannous ion (Sn[II]) is a broad-spectrum antimicrobial agent which has been shown to reduce bacterial biomass/virulence and inhibit bacterial metabolism. Stannous ions rapidly oxidize to “inactive” stannic ions (Sn [IV]) and hydrolyse to form insoluble tin compounds (for example, Stannous Hydroxide) in the presence of water-derived ions. To maximize the delivery of bioavailable Stannous ions to the oral cavity, Stannous Flouride (SnF2) dentifrices are often “stabilised” by the addition of complexing agents or developed as low water content/anhydrous (containing no water) formulations.
Alumina is a small, micronized particle that provides cleaning and polishing action on the tooth surface with low abrasivity.
Zinc is known for its ability to reduce oral malodour, inhibiting the production of volatile sulfur compounds (VSCs).
The aim of this 4-week clinical study is to evaluate the ability of an experimental toothpaste developed by Haleon, containing 0.454% Stannous Flouride, 0.3% Zinc Chloride and 1% Alumina, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste (negative control) in subjects with plaque-induced mild to moderate gingivitis; the efficacy of the experimental toothpaste in oral bacteria will be explored by quantifying live bacteria in saliva samples.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0212
Date of REC Opinion
2 Sep 2024
REC opinion
Further Information Favourable Opinion