In-situ Clinical Trial Assessing Ability to Detect and Monitor Active Caries and Their Remineralization

The goal of this clinical trial is to evaluate whether BlueCheck® can accurately detect and monitor early-stage dental caries (tooth decay) and their remineralization in adults. Participants will wear partial dentures with partially demineralized human enamel specimens. The main questions it aims to answer are: * Can BlueCheck® reliably detect early carious lesions with high sensitivity and specificity? * Does BlueCheck® visually reflect changes in remineralized enamel lesions? BlueCheck® results will be compared against standard diagnostic methods (e.g., Nyvad criteria, Diagnodent readings, surface microhardness) to see if BlueCheck® provides an objective, accurate, and visual method of detecting and monitoring early-stage caries. Participants will: * Wear a modified lower partial denture with four mounted enamel specimens for 28 days. * Use only the study-provided fluoride containing toothpaste * Attend weekly clinic visits for removal and laboratory analysis of one enamel specimen per week. * Undergo regular oral health checks and provide diary entries tracking brushing and any adverse events.

NCT Number	NCT07100626
Lead Sponsor	Incisive Technologies Pty Ltd Collaborators: Indiana University
Conditions	Dental Caries
Enrollment	12 participants
Start Date	2025-09-24
Primary Completion	2025-10-30 (estimated)
Study Completion	2026-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-20