NCT07100626

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

In Situ Clinical Trial Investigating the Ability of BlueCheck to Detect and Monitor Active Carious Lesions and Their Remineralization

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Incisive Technologies Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DEVICE	BlueCheck	Caries Detection and Monitoring

Timeline

• Start date: 2025-09-24
• Primary completion: 2025-10-30
• Completion: 2026-01-01
• First posted: 2025-08-03
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study