Dental CariesNCT07100626
In-situ Clinical Trial Assessing Ability to Detect and Monitor Active Caries and Their Remineralization
A study testing BlueCheck in people with Dental Caries, run by Incisive Technologies Pty Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- BlueCheck
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oral Health Research Institute
Indianapolis, Indiana, 46202-2876
About this study
Official title: In Situ Clinical Trial Investigating the Ability of BlueCheck to Detect and Monitor Active Carious Lesions 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 answer are:
- Can BlueCheck® reliably detect early carious lesions with high sensitivity and specificity?
- Does BlueCheck® visually reflect changes in remineralized enamel lesions?
Read more
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
- Being tested
- BlueCheck
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlueCheckDevice
Caries Detection and Monitoring
| Study group | Role | What they receive |
|---|---|---|
| Caries assessment of in-situ human enamel specimens plugs set in dentures | Experimental | Participants that had 4mm round partially demineralized human enamel samples placed on the buccal surface of posterior denture teeth. Subjects wore the denture 24hrs per day and used the assigned toothpaste twice daily. At the end of each treatment phase (i.e., after 7±1, 14±1, 21±1, and 28±1 d), one specimen was removed and further analyzed in the laboratory and the hollow of the partial denture was filled with a temporary dental material. Subjects then reinserted their partial denture, wore it twenty-four hours a day and used their assigned toothpaste twice daily, as instructed, until their next visit. This procedure was repeated until each subject completed the 28-d treatment period. At every 7 day time point, there was visual caries activity assessment , Diagnodent measurement and BlueCheck application. Receives: Device: BlueCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of BlueCheck to detect early stage carious lesions
BlueCheck will be applied to the early stage enamel carious lesions and visually assessed whether they are highlighted blue
Measured: Day 0
Specificity of BlueCheck to not visual highlight sound enamel
BlueCheck will be applied to sound enamel samples and visually assessed whether they are highlighted blue.
Measured: Day 0
Secondary outcomes (1)
Change in BlueCheck colouration of remineralised artificial carious lesions
Artificial carious lesions will be remineralised by application of fluoride containing toothpaste. Change in colouration of the lesions before and after remineralization in-situ will be compared to changes in surface microhardness over the same period.
Measured: Day 1, 7, 14, 21 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start24 Sep 2025
- Primary completion30 Oct 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incisive Technologies Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Frank Lippert, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100626
- Sponsor's protocol ID
- 25-I-126
- Status last verified
- Nov 2026
- First submitted
- 27 Jul 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Situ Clinical Trial Investigating the Ability of BlueCheck to Detect and Monitor Active Carious Lesions and Their Remineralization
- ClinicalTrials.gov ID
- NCT07100626
- Acronym / sponsor ID
- 25-I-126
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Incisive Technologies Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caries assessment of in-situ human enamel specimens plugs set in dentures | Experimental | Device: BlueCheckParticipants that had 4mm round partially demineralized human enamel samples placed on the buccal surface of posterior denture teeth. Subjects wore the denture 24hrs per day and used the assigned toothpaste twice daily. At the end of each treatment phase (i.e., after 7±1, 14±1, 21±1, and 28±1 d), one specimen was removed and further analyzed in the laboratory and the hollow of the partial denture was filled with a temporary dental material. Subjects then reinserted their partial denture, wore it twenty-four hours a day and used their assigned toothpaste twice daily, as instructed, until their next visit. This procedure was repeated until each subject completed the 28-d treatment period. At every 7 day time point, there was visual caries activity assessment , Diagnodent measurement and BlueCheck application. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlueCheckCaries Detection and Monitoring | Device | Caries assessment of in-situ human enamel specimens plugs set in dentures |
Primary outcome
Sensitivity of BlueCheck to detect early stage carious lesions
Time frame: Day 0
BlueCheck will be applied to the early stage enamel carious lesions and visually assessed whether they are highlighted blue
Specificity of BlueCheck to not visual highlight sound enamel
Time frame: Day 0
BlueCheck will be applied to sound enamel samples and visually assessed whether they are highlighted blue.
1 secondary outcome
Change in BlueCheck colouration of remineralised artificial carious lesions
Time frame: Day 1, 7, 14, 21 and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Lippert, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BlueCheck in people with Dental Caries, run by Incisive Technologies Pty Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of BlueCheck to detect early stage carious lesions (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.