An 8-Week Randomized, Controlled, Examiner-Blind, Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Stannous Fluoride in Improving Gingival Health
HALEON
Summary
The aim of this study will be to evaluate the ability of using an experimental dentifrice containing 0.454 percent (%) weight for weight (w/w) Stannous Fluoride (SnF2) to reduce gingivitis and plaque accumulation, compared with a regular fluoride toothpaste (negative control) in participants with mild to moderate gingivitis.
Description
This will be a single-center, 8-week randomized, controlled, single blind (examiner only), 2-treatment arm, parallel group, stratified study, to evaluate the efficacy of using an experimental dentifrice containing 0.454% w/w Stannous Fluoride, twice daily in reducing gingivitis and plaque accumulation in a population with a clinically measurable level of gingivitis. The clinical efficacy of the experimental dentifrice will be compared to a commercially available regular fluoride dentifrice as negative control. Sufficient participants will be screened to randomize approximately 110 participants…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participant provision of a signed and dated informed consent document indicating that the participant will have been informed of all pertinent aspects of the study before any assessment is performed. * A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures, study restrictions, Lifestyle considerations. * A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examina…
Interventions
- DrugTest Dentifrice
Experimental dentifrice containing 0.454% w/w SnF2.
- DrugReference Dentifrice (Colgate Cavity Protection Dentifrice)
A marketed regular fluoride dentifrice.
Location
- Salus Research IncFort Wayne, Indiana