NCT04050722

A Clinical Study Investigating the Efficacy of a Stannous Fluoride Dentifrice in Improving Gingival Health After Twice Daily Use for 3 Weeks

Randomized, Examiner Blind, Clinical Study Investigating the Efficacy of a Stannous Fluoride Dentifrice in Improving Gingival Health After 3 Weeks Use

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the impact of a stannous fluoride containing toothpaste in reducing gingivitis when used twice daily for a maximum for 3 weeks, when compared to a standard sodium fluoride toothpaste (negative control).

Detailed description

This will be a single center, controlled, single blind (examiner blind), randomized, two-treatment arm, parallel design, clinical study in participants (aged 18-65 years), with good general health (non-smokers) and generalized mild-moderate plaque-induced gingivitis and greater than equal to (\>=) 20 natural teeth. The study consists of 4 study visits. At Visit 1, Screening, after signing informed consent, participants will be assessed for eligibility based on the inclusion/exclusion criteria and will undergo oral soft tissue (OST) and oral hard tissue (OHT) assessments. Participants will return between 1 and 28 days following the screening visit for the Visit 2, baseline where they will undergo, a full OST examination followed by assessments of gingival inflammation (MGI), gingival bleeding (BI) and supra-gingival plaque (TPI). Eligible participants will be stratified based on gender and baseline mean whole mouth MGI score (low: less than equal to (\<=) 2.00/High greater than (\>) 2.00), to ensure a balance of gingivitis across both treatment groups and then randomized to study product. All randomized participants will receive full mouth dental prophylaxis (followed by flossing) to remove sub and supra-gingival calculus, stain, plaque and debris from the teeth. All participants will enter the treatment period with no visible plaque (TPI=0). After all clinical assessments, participants will be instructed to brush for 1 timed minute at site with their assigned study product, after which they will be instructed to continue using this twice daily (morning and evening) for 2 weeks. After 2 weeks the participants will return to site for their Week 2 (Visit 3) assessments. They will then continue using their test dentifrice for a further week and will continue to record all brushing events in the diary provided, after which they will return for their Week 3 (Visit 4) assessments. All assessments will be carried out on the facial and lingual/palatal surfaces of each incisor, canine, pre-molar and molar, excluding third molars. After the Week 3 visit, study closeout procedures will take place and the participant may undergo an additional prophylaxis if it is deemed necessary by the examiner. Adverse events and incidents will be recorded from informed consent and at the end of each study visit.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DRUG	Sensodyne Repair and Protect	Participants will brush their teeth with Sensodyne Repair and Protect (containing 0.454% stannous fluoride) for 1 timed minute twice a day (morning and evening), for 3 weeks.
DRUG	Colgate Cavity Protection	Participants will brush their teeth with Colgate Cavity Protection repair and protect (containing sodium fluoride) for 1 timed minute twice a day (morning and evening), for 3 weeks.

Timeline

• Start date: 2019-10-07
• Primary completion: 2019-11-13
• Completion: 2019-11-13
• First posted: 2019-08-08
• Last updated: 2020-11-19
• Results posted: 2020-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study