Status:
ACTIVE_NOT_RECRUITING
Clinical Study to Evaluate the Anti-cavity Efficacy of Three Dentifrices: An In Situ Model
Lead Sponsor:
Colgate Palmolive
Collaborating Sponsors:
Federal University of Alagoas
Conditions:
Demineralization
Remineralization
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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, si...
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 applianc...
Eligibility Criteria
Inclusion
- Potential subjects must meet ALL of the following 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
- Potential subjects must NOT HAVE ANY of the following conditions:
- 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.
Key Trial Info
Start Date :
October 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07134231
Start Date
October 9 2025
End Date
December 1 2025
Last Update
December 10 2025
Active Locations (1)
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1
Federal University of Alagoas
Maceió, Alagoas, Brazil, 57072-970