A 24-Week, Randomised, Controlled, Examiner-blind, Clinical Study to Evaluate the Efficacy of an Experimental Stannous Fluoride Dentifrice in Improving Gingival Health and Reducing Plaque Accumulation
HALEON
Summary
The aim of this 24-week clinical study is to evaluate the ability of an experimental dentifrice containing 0.454 percent (%) weight by weight (w/w) Stannous fluoride (SnF2); to improve gingival health, plaque reduction and prevention of plaque accumulation compared with a regular fluoride dentifrice (negative control) in participants with mild to moderate gingivitis.
Description
This will be a single-center, 24-week, randomized, controlled, single blind (examiner only), 3-treatment arms, 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 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. In addition, a marketed dentifrice containing 0.454% w/w SnF2 is included as positi…
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 has been informed of all pertinent aspects of the study before any assessment is performed. * Participant is of either sex and any gender who, at the time of screening, is at least 18 years old, inclusive. * A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures. * A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or…
Interventions
- DrugTest Dentifrice
Experimental dentifrice containing 0.454% w/w SnF2.
- DrugParodontax Complete Protection
Marketed dentifrice containing 0.454% w/w SnF2.
- DrugColgate Cavity Protection
Marketed regular fluoride dentifrice.
Location
- Salus Research, Inc.Fort Wayne, Indiana