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

Sponsored by Colgate Palmolive

About this trial

Last updated 3 months ago

Study ID

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

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18 to 70 Years
All Sexes

Trial Timing

Ended 5 months ago

What is this trial about?

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.

What are the Participation Requirements?

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 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.