New In Situ Model Design for Caries and Erosion

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.

Timeline

Start

2026-08-03

Primary completion

2027-01-29

Completion

2027-01-29

Publications

• Background Rikvold PT, Kambourakis Johnsen K, Leonhardt D, Mollebjerg A, Nielsen SM, Skov Hansen LB, Meyer RL, Schlafer S. A New Device for In Situ Dental Biofilm Collection Additively Manufactured by Direct Metal Laser Sintering and Vat Photopolymerization. 3D Print Addit Manuf. 2023 Oct 1;10(5):1036-1045. doi: 10.1089/3dp.2022.0009. Epub 2023 Oct 10.

Drugs

Indications