Caries,DentalNCT07648212
Artificial Intelligence (AI) for Proximal Caries Detection and Its Impact on Treatment Threshold
A study testing Review of Radiograph Images in people with Caries,Dental, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of artificial intelligence on proximal caries detection and subsequent treatment decisions of early learners and compare those with outcomes of experienced learners. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Caries,Dental
- What is being tested?
- Review of Radiograph Images
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Dental students who do not have previous experience with caries detection (such as first year dental students)
- Residents that do not have frequent exposure to caries detection, such as orthodontic, periodontic, oral surgery graduate residents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Carmen Boren, drcarmen@umich.edu
Margherita Fontana, DDS, PhD
About this study
Official title: Artificial Intelligence for Proximal Caries Detection and Its Impact on Treatment Threshold: Randomized Trial
The purpose of this study is to assess the impact of artificial intelligence on proximal caries detection and subsequent treatment decisions of early learners and compare those with outcomes of experienced learners.
- Conditions
- Caries,Dental
- Being tested
- Review of Radiograph Images
- Keywords
- Artificial intelligence, Dental students (years 2-4), Dental resident or junior faculty
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Review of Radiograph ImagesOther
Participants will be asked to attend two visits and view a randomized series of dental radiographs (10 at each visit). Participants will answer a set of questions for each image reviewed. Some of the radiographs will have an Artificial Intelligence enhancement and some will not. Participants will be asked to return within about one week of the first visit to view the second set of x-rays and answer the survey questions.
| Study group | Role | What they receive |
|---|---|---|
| Early Learners - Dental students | Other | Not described Receives: Other: Review of Radiograph Images |
| Late Learners - Dental resident or junior faculty | Other | Not described Receives: Other: Review of Radiograph Images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion severity
Levels for this outcome will be sound, outer enamel, inner enamel/outer dentin, inner dentin.
Measured: approximately 1 week (2 sessions)
Diagnostic accuracy
Measured: Approximately 1 week (2 sessions)
Specificity
Measured: Approximately 1 week (2 sessions)
Overall sensitivity
Measured: Approximately 1 week (2 sessions)
Sensitivity for outer enamel
Measured: Approximately 1 week (2 sessions)
Sensitivity for inner enamel/outer dentin
Measured: Approximately 1 week (2 sessions)
Sensitivity for inner dentin
Measured: Approximately 1 week (2 sessions)
Secondary outcomes (1)
Intervention
(levels for this outcome will be none, non-restorative, restorative)
Measured: approximately 1 week (2 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start5 Oct 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This proposed study is designed to compare a binary outcome (overall diagnostic accuracy, and surgical restorative intervention vs. non-surgical restorative/no intervention) between evaluations with AI and without AI. The comparisons are made separately for early learners and late learners.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Delta Dental Plan of Michigan
- Responsible party
- Principal investigator, Margherita Fontana, University of Michigan
- Investigators
- Margherita Fontana, DDS, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648212
- Sponsor's protocol ID
- HUM00276058
- Status last verified
- Oct 2026
- First submitted
- 9 Jun 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Interested parties and contact the PI for potential collaboration
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence for Proximal Caries Detection and Its Impact on Treatment Threshold: Randomized Trial
- ClinicalTrials.gov ID
- NCT07648212
- Acronym / sponsor ID
- HUM00276058
- Conditions
- Caries,Dental
- Keywords
- Artificial intelligence, Dental students (years 2-4), Dental resident or junior faculty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Delta Dental Plan of Michigan
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 Jun 2026 (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 purpose of this study is to assess the impact of artificial intelligence on proximal caries detection and subsequent treatment decisions of early learners and compare those with outcomes of experienced learners.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This proposed study is designed to compare a binary outcome (overall diagnostic accuracy, and surgical restorative intervention vs. non-surgical restorative/no intervention) between evaluations with AI and without AI. The comparisons are made separately for early learners and late learners.
| Arm | Type | Receives |
|---|---|---|
| Early Learners - Dental students | Other | Other: Review of Radiograph Images |
| Late Learners - Dental resident or junior faculty | Other | Other: Review of Radiograph Images |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Dental students who do not have previous experience with caries detection (such as first year dental students)
- Residents that do not have frequent exposure to caries detection, such as orthodontic, periodontic, oral surgery graduate residents.
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 |
|---|---|---|
| Review of Radiograph ImagesParticipants will be asked to attend two visits and view a randomized series of dental radiographs (10 at each visit). Participants will answer a set of questions for each image reviewed. Some of the radiographs will have an Artificial Intelligence enhancement and some will not. Participants will be asked to return within about one week of the first visit to view the second set of x-rays and answer the survey questions. | Other | Early Learners - Dental students, Late Learners - Dental resident or junior faculty |
Primary outcome
Lesion severity
Time frame: approximately 1 week (2 sessions)
Levels for this outcome will be sound, outer enamel, inner enamel/outer dentin, inner dentin.
Diagnostic accuracy
Time frame: Approximately 1 week (2 sessions)
Specificity
Time frame: Approximately 1 week (2 sessions)
Overall sensitivity
Time frame: Approximately 1 week (2 sessions)
Sensitivity for outer enamel
Time frame: Approximately 1 week (2 sessions)
Sensitivity for inner enamel/outer dentin
Time frame: Approximately 1 week (2 sessions)
Sensitivity for inner dentin
Time frame: Approximately 1 week (2 sessions)
1 secondary outcome
Intervention
Time frame: approximately 1 week (2 sessions)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. Interested parties and contact the PI for potential collaboration
Related trials for Caries,Dental
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Not yet recruiting
Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical Trial)
Dental Caries, Cervical Caries
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
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.
Margherita Fontana, DDS, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Review of Radiograph Images in people with Caries,Dental, run by University of Michigan 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 0 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmen Boren, DDS, FAGD (701-240-8191, drcarmen@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion severity (time frame: approximately 1 week (2 sessions)). The study lists 7 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 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.