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

NCT ID: NCT07100626

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-24
• Study Completion Date: 2026-01-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Interventions

BlueCheck

Caries Detection and Monitoring

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• provide voluntary, written informed consent;
• be between 18 and 85 years old;
• understand and be willing, able and likely to comply with all study procedures and restrictions;
• be wearing a removable mandibular partial denture with sufficient room to accommodate four (4) human enamel specimens (4 mm round) in their partial denture on both sides (two specimens on each side, bilateral partial denture) or one side (4 specimens on one side, unilateral partial denture)
• be willing and capable of wearing their removable partial denture 24 hours a day for four (4), one-week treatment periods, maximum total duration four (4) weeks;
• be willing to allow study personnel to drill specimen sites in the posterior section of one or both sides of their lower partial denture (teeth and/or buccal flange area below the teeth); and
• be in good medical and dental health with no active caries or periodontal disease.
• have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min).

Exclusion Criteria

• currently be pregnant (self-reported), intending to become pregnant during the study period or breast feeding;
• currently have any medical condition that could be expected to interfere with the subject's safety during the study period;
• currently be taking antibiotics or have taken antibiotics in the two weeks prior to the beginning treatment;
• known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients;
• have participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment; or
• be taking fluoride supplements, required to use a fluoride mouthrinse or have received a professional fluoride treatment in the two weeks preceding specimen placement.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oral Health Research Institute, Indiana University School of Dentistry

UNKNOWN

Sponsor Role: collaborator

Incisive Technologies Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Lippert, PhD

Role: PRINCIPAL_INVESTIGATOR

Oral Health Research Institute, Indiana University School of Dentistry

Locations

Oral Health Research Institute

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

25-I-126

Identifier Type: -

Identifier Source: org_study_id