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New In Situ Model Design for Caries and Erosion
Sponsor: Indiana University
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
Conditions
Interventions
0 ppm fluoride toothpaste
Toothpaste containing 0 ppm fluoride (F)
250 ppm fluoride toothpaste (dose-response control)
Toothpaste containing 250 ppm fluoride, as NaF (sodium fluoride)
1150 ppm fluoride toothpaste
Marketed toothpaste product containing 1150 ppm fluoride, as NaF (sodium fluoride)
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