Artificial Intelligence (AI) for Proximal Caries Detection and Its Impact on Treatment Threshold

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caries,Dental
• Intervention / Treatment: Other: Review of Radiograph Images

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carmen Boren, DDS, FAGD; Phone Number: 701-240-8191; Email: drcarmen@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
      • Contact: Carmen Boren; Email: drcarmen@umich.edu
      • Principal Investigator: Margherita Fontana, DDS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Early learner Inclusion Criteria:

• Provide informed consent
• Willing to comply with all study procedures and be available for the duration of the study
• Dental student in second, third, or fourth year of dental school at University of Michigan School of Dentistry

Late learner Inclusion Criteria:

• Provide informed consent
• Willing to comply with all study procedures and be available for the duration of the study
• Dental resident or junior faculty having at least 2 years of clinical experience outside of a dental education setting

Exclusion Criteria for participants:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Early Learners - Dental students	Other: Review of Radiograph Images; 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.
Other: Late Learners - Dental resident or junior faculty	Other: Review of Radiograph Images; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion severity	Levels for this outcome will be sound, outer enamel, inner enamel/outer dentin, inner dentin.	approximately 1 week (2 sessions)
Diagnostic accuracy		Approximately 1 week (2 sessions)
Specificity		Approximately 1 week (2 sessions)
Overall sensitivity		Approximately 1 week (2 sessions)
Sensitivity for outer enamel		Approximately 1 week (2 sessions)
Sensitivity for inner enamel/outer dentin		Approximately 1 week (2 sessions)
Sensitivity for inner dentin		Approximately 1 week (2 sessions)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention	(levels for this outcome will be none, non-restorative, restorative)	approximately 1 week (2 sessions)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Delta Dental Plan of Michigan
• Investigators: Principal Investigator: Margherita Fontana, DDS, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Artificial intelligence; Dental students (years 2-4); Dental resident or junior faculty
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: HUM00276058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Interested parties and contact the PI for potential collaboration

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No