NCT02388178

To Determine the Ability of a New Product Formulation to Remineralize an Early Caries Lesion by an In-situ Study

Assessment of 1450 Ppm Fluoride/Arginine Toothpaste Using an Intra-oral Remineralization-demineralization Model.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Colgate Palmolive · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	Control toothpaste containing no anti-cavity ingredients	Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.
DRUG	Experimental toothpaste containing fluoride and amino acid (arginine)	Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.
DRUG	Fluoride toothpaste containing fluoride as the anti-cavity ingredient	Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-03-13
• Last updated: 2022-09-27