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

NCT07100626 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-01-20

No results posted yet for this study

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

DEVICE

BlueCheck

Caries Detection and Monitoring

Sponsors & Collaborators

  • Oral Health Research Institute, Indiana University School of Dentistry

    collaborator UNKNOWN

  • Incisive Technologies Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Frank Lippert, PhD · Oral Health Research Institute, Indiana University School of Dentistry

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-24
Primary Completion
2025-10-30
Completion
2026-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100626 on ClinicalTrials.gov