Blue dye could spot cavities before they start
NCT ID NCT07100626
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a blue dye called BlueCheck to see if it can find early tooth decay and track whether the decay is healing. Twelve adults will wear a special denture with pieces of human tooth enamel for 28 days. The dye's results are compared to standard dental tools to see if it offers a simple, accurate way to catch cavities early.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jan 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Oral Health Research Institute
Indianapolis, Indiana, 46202-2876, United States
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Other studies related to the condition(s) this trial covers.
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