NCT07134231

Clinical Study to Evaluate the Anti-cavity Efficacy of Three Dentifrices: An In Situ Model

In Situ Evaluation of the Anti-cavity Efficacy of Three Dentifrices Using an Intra-oral Enamel Demineralization-Remineralization Model

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Colgate Palmolive · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Clinical study to evaluate the anti-cavity effectiveness of three dentrifices using an intra-oral enamel Demineralization and Remineralization In-Situ Model. This is a six-week duration, Phase III, single-center, triple-blind crossover study. Thirty-six healthy adults will be randomly allocated to three groups for the treatment phases, which are interspersed with washout periods.

Detailed description

This Phase III, randomized, triple-blind, crossover study will assess the anti-cavity effectiveness of three different dentrifices. Thirty-six participants, aged 18-70, will use an intra-oral appliance. For six weeks, they will be divided into three treatment groups and instructed to brush twice daily with one of the following: one using a fluoride-free toothpaste with a chalk base and herbal ingredients, another using a fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base, and a negative control group using a fluoride-free toothpaste in a PCC/RNCC base. Each participant will receive a soft-bristle toothbrush and the toothpastes assigned. Between each five-day treatment phase, participants will have a nine-day washout period, using a fluoride-free toothpaste in a PCC/RNCC base. The study's eight-visit schedule includes a baseline visit, three treatment phases, three washout periods interspersed between the treatment phases, and a final visit. The primary outcome will be the measurement of changes in enamel microhardness, with assessments taking place both before and after each treatment to determine the impact on the enamel. The expected outcome is the confirmation of the alternative hypothesis, which predicts a reduction in the percentage of mineral loss from the surface of bovine enamel after using dentifrices containing 1000 ppm MFP with 1.5% arginine or herbal ingredients for five days each, compared to the control group. The percentage of mineral loss on the tooth surface relative to baseline will be used to quantify the extent of reduction in enamel demineralization. A two factor ANCOVA using the baseline as the covariate will be conducted to determine if a significant treatment effect exists. Adverse events and compliance will be closely monitored, with strict confidentiality maintained for all participants.

Conditions

• Demineralization
• Remineralization
• Dental Cavity
• Enamel Lesions

Interventions

Type	Name	Description
DRUG	Fluoride free toothpaste in a chalk base	Fluoride free toothpaste in a chalk base with herbal ingredients
DRUG	Fluoride Toothpaste	Fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base
DRUG	Fluoride free toothpaste in a PCC/RNCC base	Fluoride free toothpaste in a PCC/RNCC base
DEVICE	Toothbrush	A commercially available adult soft bristle toothbrush

Timeline

• Start date: 2025-10-09
• Primary completion: 2025-12-11
• Completion: 2025-12-11
• First posted: 2025-08-21
• Last updated: 2026-02-06

Locations

1 site across 1 country: Brazil