Clinical Study to Evaluate the Anti-cavity Efficacy of Three Dentifrices: An In Situ Model (NCT07134231) | Clinical Trial Compass
CompletedPhase 3
Clinical Study to Evaluate the Anti-cavity Efficacy of Three Dentifrices: An In Situ Model
Brazil36 participantsStarted 2025-10-09
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: 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 Criteria: 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 subj…