In-situ Clinical Trial Assessing Ability to Detect and Monitor Active Caries and Their Reminerali… (NCT07100626) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
In-situ Clinical Trial Assessing Ability to Detect and Monitor Active Caries and Their Remineralization
United States12 participantsStarted 2025-09-24
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of BlueCheck to detect early stage carious lesions
Timeframe: Day 0
2
Specificity of BlueCheck to not visual highlight sound enamel