NCT03852056

The Clinical Investigation of a New Toothpaste Containing Stannous Fluoride as Compared to a Commercially Available Fluoride Toothpaste in Reducing Plaque and Gingivitis

The Clinical Investigation of a New Toothpaste Containing SnF as Compared to Colgate Fluoride Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in China

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Colgate Palmolive · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the clinical efficacy of a new toothpaste containing stannous fluoride (SnF) as compared to Colgate Fluoride Toothpaste in reducing gingivitis and dental plaque.

Detailed description

This is a 6 month, take home, tooth brushing research study to evaluate a new toothpaste. Qualified subjects will be enrolled and randomized to either one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three and six months of product use. All subjects will be followed for adverse events throughout the study.

Conditions

• Dental Plaque
• Gingivitis

Interventions

Type	Name	Description
DRUG	MFP Fluoride toothpaste	Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,
DRUG	Stannous fluoride toothpaste	Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,

Timeline

• Start date: 2017-05-25
• Primary completion: 2017-12-07
• Completion: 2017-12-07
• First posted: 2019-02-22
• Last updated: 2019-02-22

Locations

1 site across 1 country: China