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Search / Trial NCT06732518

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

Launched by COLGATE PALMOLIVE · Dec 12, 2024

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Enamel Demineralization Remineralization Fluoride Toothpaste Enamel Microhardness

ClinConnect Summary

This clinical trial is looking at how effective three different toothpaste brands are at preventing cavities. The study involves adults aged 18 to 70 years who have at least 20 healthy teeth. Participants will be divided into groups to try each toothpaste over six weeks while wearing a special mouthguard that helps measure changes in tooth enamel, which is the hard outer layer of teeth.

To take part in this study, individuals must be in good health and not have any serious dental issues or medical conditions that could interfere with the trial. They also need to be willing to wear the mouthguard throughout the day, except when eating or drinking. The study is currently recruiting participants, and those who join will help researchers understand which toothpaste might be best for preventing cavities.

Gender

ALL

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.

About Colgate Palmolive

Colgate-Palmolive is a global leader in oral care, personal care, home care, and pet nutrition, dedicated to enhancing the health and well-being of consumers worldwide. With a strong commitment to innovation and sustainability, the company conducts clinical trials to advance its product offerings, ensuring safety and efficacy while adhering to the highest ethical standards. Colgate-Palmolive's rigorous research initiatives are designed to generate scientific evidence that supports the development of effective solutions, ultimately promoting healthier lifestyles and contributing to the betterment of communities globally.

Locations

Maceió, Al, Brazil

Patients applied

0 patients applied

Trial Officials

Natanael Silva, PhD

Principal Investigator

Federal University of Alagoas

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported