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ACTIVE NOT RECRUITING
NCT07849270
PHASE3

New In Situ Model Design for Caries and Erosion

Sponsor: Indiana University

View on ClinicalTrials.gov

Summary

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.

Official title: Novel In Situ Caries and ETW Models Development: Safety and Validation Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-08-03

Completion Date

2027-01-29

Last Updated

2026-09-30

Healthy Volunteers

Yes

Interventions

DRUG

0 ppm fluoride toothpaste

Toothpaste containing 0 ppm fluoride (F)

DRUG

250 ppm fluoride toothpaste (dose-response control)

Toothpaste containing 250 ppm fluoride, as NaF (sodium fluoride)

DRUG

1150 ppm fluoride toothpaste

Marketed toothpaste product containing 1150 ppm fluoride, as NaF (sodium fluoride)

DEVICE

Mandibular intraoral appliance

After impressions of both dental arches are taken, a mandibular appliance consisting of a 3D-printed metal frame and acrylic buccal flanges (blue on the right and red on the left) will be made. The appliance will be tested and adjusted for optimal fit and comfort before the experimental phase of the study. At each testing period, 4 gauze-covered 4-millimeter round partially demineralized human enamel specimens will be placed in the right buccal acrylic flange (blue, caries) side of the mandibular appliance and 4 sound human enamel specimens previously mounted on 3 millimeter round metal holders will be placed on the other acrylic flange (red, ETW) side of the same appliance. Subjects will wear their appliance 24 hours a day, except during study procedures, meals/snacks, and drinking (e.g. milk, juice, sports drinks, tea, etc.) except water.

Locations (1)

Oral Health Research Institute of the Indiana University School of Dentistry

Indianapolis, Indiana, United States