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

NCT07134231 | Completed Phase 3 DMC

• 1 other identifier: CRO-2025-08-DEMI-REMI-BZ-CB
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Remineralization; Dental Cavity; Enamel Lesions; Demineralization

Keywords

enamel mircrohardness; enamel demineralization-remineralization

Outcome Measures

Primary Outcomes (1)

• Microhardness change

  The primary outcome of this study will be the change in the hardness of an intra-oral appliance before and after treatment. It will be determined by measuring the length of an indentation made on the appliance, which in turn allows for the calculation of its hardness value. The effectiveness of the treatment in reducing enamel demineralization by quantifying the percentage of mineral loss relative to the baseline will also be assessed.

  6 weeks

Study Arms (4)

Test Group

EXPERIMENTAL

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

Positive Control Group

ACTIVE COMPARATOR

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

Negative Control Group

SHAM COMPARATOR

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 Group

OTHER

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 free toothpaste in a chalk base DRUG

Fluoride free toothpaste in a chalk base with herbal ingredients

Test Group

Fluoride Toothpaste DRUG

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

Positive Control Group

Fluoride free toothpaste in a PCC/RNCC base DRUG

Fluoride free toothpaste in a PCC/RNCC base

Negative Control Group; Washout Group

Toothbrush DEVICE

A commercially available adult soft bristle toothbrush

Negative Control Group; Positive Control Group; Test Group; Washout Group

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

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Natanael Santos, 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
• 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 with an intra-oral enamel Demineralization - Remineralization In-Situ Model.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: October 9, 2025
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: February 6, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)