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

NCT ID: NCT07134231

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-09
• Study Completion Date: 2025-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Test Group

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

Group Type: EXPERIMENTAL

Fluoride free toothpaste in a chalk base

Intervention Type: DRUG

Fluoride free toothpaste in a chalk base with herbal ingredients

Toothbrush

Intervention Type: DEVICE

A commercially available adult soft bristle toothbrush

Positive Control Group

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

Group Type: ACTIVE_COMPARATOR

Fluoride Toothpaste

Intervention Type: DRUG

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

Toothbrush

Intervention Type: DEVICE

A commercially available adult soft bristle toothbrush

Negative Control Group

Subjects will brush using a fluoride free toothpaste in a PCC/RNCC base and a soft bristle toothbrush

Group Type: SHAM_COMPARATOR

Fluoride free toothpaste in a PCC/RNCC base

Intervention Type: DRUG

Fluoride free toothpaste in a PCC/RNCC base

Toothbrush

Intervention Type: DEVICE

A commercially available adult soft bristle toothbrush

Washout Group

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.

Group Type: OTHER

Fluoride free toothpaste in a PCC/RNCC base

Intervention Type: DRUG

Fluoride free toothpaste in a PCC/RNCC base

Toothbrush

Intervention Type: DEVICE

A commercially available adult soft bristle toothbrush

Interventions

Fluoride free toothpaste in a chalk base

Fluoride free toothpaste in a chalk base with herbal ingredients

Intervention Type: DRUG

Fluoride Toothpaste

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

Intervention Type: DRUG

Fluoride free toothpaste in a PCC/RNCC base

Fluoride free toothpaste in a PCC/RNCC base

Intervention Type: DRUG

Toothbrush

A commercially available adult soft bristle toothbrush

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Alagoas

OTHER

Sponsor Role: collaborator

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natanael Santos, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Alagoas

Locations

Federal University of Alagoas

Maceió, Alagoas, Brazil

Countries

Brazil

Other Identifiers

CRO-2025-08-DEMI-REMI-BZ-CB

Identifier Type: -

Identifier Source: org_study_id