NCT06427499

The Clinical of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis.

The Clinical Investigation of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis: A Three-Month Study in Thailand

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Colgate Palmolive · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Qualified subjects will be enrolled and randomly assigned to either of the two study groups based on their initial Plaque and Gingivitis scores. During the first visit, subjects will undergo three key procedures: 1) evaluation for baseline plaque and gingivitis, 2) brushing with the assigned regimen products for two minutes, and 3) assessment for post-brushing plaque only. Subjects will be provided with clear instructions for regimen product usage and will be expected to adhere to these instructions. Follow-up evaluations for plaque and gingivitis will be conducted at one week, six weeks, and three months after initiation of regimen product use. Throughout the study period, continuous monitoring for adverse events will be carried out for all subjects.

Conditions

• Plaque
• Gingivitis

Interventions

Type	Name	Description
DRUG	Stannous fluoride toothpaste	brush 2 min morning \& night daily
DRUG	Colgate Cavity Protection Toothpaste	brush 2 min morning \& night daily

Timeline

• Start date: 2024-04-22
• Primary completion: 2024-08-05
• Completion: 2024-08-05
• First posted: 2024-05-24
• Last updated: 2026-03-19

Locations

1 site across 1 country: Thailand

Regulatory

• FDA-regulated drug study