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In-situ Clinical Trial Assessing Ability to Detect and Monitor Active Caries and Their Remineralization
NCT07100626 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DEVICE BlueCheck
Study Locations (1)
Indiana
- Oral Health Research Institute — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-09-24 |
| Est. Completion | 2026-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07100626
The ClinicalTrials.gov registry entry for NCT07100626 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incisive Technologies Pty, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Dental Caries appearing as the primary indexed condition, and to 1 intervention — of which BlueCheck is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07100626 reports 1 study location spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07100626 about?
NCT07100626 is a clinical study titled "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...
What is the current status of trial NCT07100626?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2025-09-24. Estimated completion is 2026-01.
What conditions does trial NCT07100626 study?
This clinical trial studies the following conditions: Dental Caries. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07100626?
The interventions under investigation include: BlueCheck (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07100626?
This trial is sponsored by Incisive Technologies Pty, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07100626 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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