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

NCT06732518 | Completed Phase 3 DMC

• 1 other identifier: CRO-2024-04-DEM-REM-BZ-BG
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical study to evaluate the anti-cavity efficacy of three dentifrices using an intra-oral enamel Demineralization - Remineralization In-Situ Model. This is a Phase III, single-center, triple-blind with a crossover design. It involves 36 participants aged between 18 and 70, randomized into 3 different groups + a washout group, and spans 6 weeks.

Conditions

Enamel Lesions; Demineralization, Tooth; Remineralization; Dental Cavity

Keywords

enamel demineralization-remineralization; fluoride toothpaste; enamel microhardness

Outcome Measures

Primary Outcomes (1)

• Microhardness change

  The primary measured response will be a change in indentation length in the intra-oral appliance before and after treatment for microhardness. The indentation length will be used to calculate a hardness value. The percentage of mineral loss on the bovine tooth enamel surface relative to baseline will be used to quantify the extent of reduction in enamel demineralization.

  6 weeks

Study Arms (4)

Fluoride toothpaste

EXPERIMENTAL

Subjects will brush using a fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base and a soft bristle toothbrush

Drug: Fluoride Toothpaste; Device: Toothbrush

Fluoride free toothpaste in a chalk base

ACTIVE COMPARATOR

Subjects will brush using a fluoride free toothpaste in a chalk base with herbal ingredients and a soft bristle toothbrush

Drug: Fluoride free toothpaste in a chalk base; Device: Toothbrush

Fluoride free toothpaste in a PCC/RNCC base

ACTIVE COMPARATOR

This is a negative control group in which subjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush

Drug: Fluoride free toothpaste in a PCC/RNCC base; Device: Toothbrush

Washout

OTHER

This is a washout group in which subjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush for 9 days, between the treatment phases

Drug: Fluoride free toothpaste in a PCC/RNCC base; Device: Toothbrush

Interventions

Fluoride Toothpaste DRUG

Fluoride toothpaste containing 1000 ppm MFP and 1.5% arginine in a PCC/RNCC base

Fluoride toothpaste

Fluoride free toothpaste in a chalk base DRUG

Fluoride free toothpaste in a chalk base with herbal ingredients

Fluoride free toothpaste in a chalk base

Fluoride free toothpaste in a PCC/RNCC base DRUG

Fluoride free toothpaste in a PCC/RNCC base

Fluoride free toothpaste in a PCC/RNCC base; Washout

Toothbrush DEVICE

A commercially available adult soft bristle toothbrush

Fluoride free toothpaste in a PCC/RNCC base; Fluoride free toothpaste in a chalk base; Fluoride toothpaste; Washout

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, between 18-70 years of age (inclusive);
• Informed Consent Form signed and availability for the duration of the study;
• Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
• Willingness to provide information related to their medical history;
• Minimum of 20 uncrowned permanent natural teeth (excluding third molars); Normal salivary flow;
• Willingness to wear an intra-oral appliance all day as instructed except when eating and drinking.

You may not qualify if:

• Oral pathology, chronic disease, or a history of allergy to testing products;
• Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
• Subject participating in any other clinical study;
• Subject pregnant or breastfeeding;
• Subject allergic to oral care products, personal care consumer products, or their ingredients;
• Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study;
• A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc.;
• Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
• Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). Pocket depth equal or greater than 4 mm
• Five or more decayed, untreated dental sites (cavities);
• Current smokers and subjects with a history of alcohol or drug abuse;
• Dental work prevents wearing of the appliance or a reported need to wear a night guard.

Sponsors & Collaborators

• Colgate Palmolive: lead
• Federal University of Alagoas: collaborator

Study Sites (1)

Federal University of Alagoas

Maceió, Alagoas, 57072-970, Brazil

Location

MeSH Terms

Conditions

Tooth Demineralization; Dental Caries

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Natanael Silva, PhD

  Federal University of Alagoas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this clinical trial, masking involves several key roles to ensure unbiased results. The Participant, Care Provider, Investigator, and Outcomes Assessor are all masked in this triple-blind study. This means that the participants do not know which group they have been assigned to, the care providers administering the treatments are unaware of the specific products being used by each participant, the investigators conducting the study do not know the group assignments, and the outcomes assessors evaluating the results are blind to the treatment allocations. This comprehensive masking approach is designed to minimize any potential biases and maintain the integrity of the study results.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase III, randomized, one-center, crossover group, triple blind, clinical study.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: March 13, 2025
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)