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New In Situ Model Design for Caries and Erosion

StatusActive, Not Recruiting
PhasePhase 3
Started2026-08-03
View on ClinicalTrials.gov ↗
This study will test simultaneously and independently two novel in situ models, one for caries and one for erosive tooth wear (ETW), based on the simulation of these dental conditions on enamel specimens placed on 3D-printed mandibular appliances. Caries simulation will be done on the right side (color-coded blue) of the appliance, while ETW on the left side (color-coded red) and their outcomes evaluated independently. The study aims at testing the safety, compliance and F-efficacy (dose-response) of the models. The study will follow a double-blind, single-center, 3-way within-subject crossover design. Treatments will consist of dentifrices, or toothpastes, (1150 ppm F as sodium fluoride, 250 ppm F as sodium fluoride and 0 ppm F/Negative Control) used twice a day.
Trial Details
NCT Number NCT07849270
Lead Sponsor Indiana University
Conditions Caries, Erosive Tooth Wear
Enrollment 12 participants
Start Date 2026-08-03
Primary Completion 2027-01-29 (estimated)
Study Completion 2027-01-29 (estimated)
Updated on ClinicalTrials.gov 2026-09-30