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

NCT02388178 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-09-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Colgate Palmolive

    lead INDUSTRY

Principal Investigators

  • Bennet Amaechi, PhD, DDS · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-07-31
Completion
2015-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02388178 on ClinicalTrials.gov