Evaluation of the Anti-cavity Efficacy of Three Dentifrices Using an Intra-oral Enamel Deminerali… (NCT06732518) | Clinical Trial Compass
CompletedPhase 3
Evaluation of the Anti-cavity Efficacy of Three Dentifrices Using an Intra-oral Enamel Demineralization - Remineralization In-Situ Model
Brazil36 participantsStarted 2025-03-13
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 …