- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07027189
- Original Trial
The Impact of Artificial Intelligence on Dentists' Decision-Making Process During Caries Detection (DECIDE-AI)
DECIDE-AI:The Impact of Artificial Intelligence on Dentists' Decision-Making Process During Caries Detection: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6525 EX
- Department of Dentistry Radboud Uniersity Medical Center
-
Contact:
- Dilek Sezen-Hulsmans, Dentist
- Phone Number: 00491708975313
- Email: dilek.sezen-hulsmans@radboudumc.nl
-
Contact:
- Dr. Cenci
- Email: Max.Cenci@radboudumc.nl
-
Principal Investigator:
- Dilek Sezen-Hulsmans, Dental Medical Doctor
-
Principal Investigator:
- Dr. Cenci
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Graduated, practising dentists.
- At least three years of experience
Exclusion Criteria:
- Retired dentists.
- Specialized practitioners (e.g., orthodontists and oral surgeons) if their typical practice does not involve routine caries diagnostics and treatment planning.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Phase 1: Caries detection without AI, Phase 2: Caries detection with AI
In this group participants will examine caries lesions on the radiographs without AI support first.
Then, after a wash-out period of one month, all participants will re-examine the same radiographs with AI.
|
AI-based diagnostic programs have proved to enhance diagnostic performance, however research on its effects on treatment decisions is scarce.
In contrast to other studies focusing on AI's accuracy or the resulting increase in dentists' accuracy, this study aims to investigate the differences in dentists' treatment recommendations when supported by AI versus when they are not during caries detection.
|
|
Active Comparator: Phase 1: Caries detection with AI, Phase 2: Caries detection without AI
In this group participants will examine caries lesions on the radiographs with AI support first.
Then, after a wash-out period of one month, all participants will re-examine the same radiographs without AI.
|
AI-based diagnostic programs have proved to enhance diagnostic performance, however research on its effects on treatment decisions is scarce.
In contrast to other studies focusing on AI's accuracy or the resulting increase in dentists' accuracy, this study aims to investigate the differences in dentists' treatment recommendations when supported by AI versus when they are not during caries detection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment decisions: Compare the treatment recommendations of dentists for caries lesions detected with and without AI support.
Time Frame: Each participant will be assessed over a period of up to 2 months (includes both evaluation phases and washout period)
|
The given options will be "no treatment", "non-invasive treatment" (fluoride varnish, polishing, sealing), and "restoration". Participants' answers will be compared to a reference standard. |
Each participant will be assessed over a period of up to 2 months (includes both evaluation phases and washout period)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic Accuracy in Caries Detection
Time Frame: Each participant will be assessed over a period of up to 2 months (includes both evaluation phases and washout period)
|
RA0: No radiolucency - No visible caries. RA1: Radiolucency confined to the outer half of enamel - Enamel caries. RA2: Radiolucency extending to the inner half of enamel but not reaching dentin - Moderate enamel caries. RA3: Radiolucency extending into the outer third of dentin - Dentin caries. RA4: Radiolucency extending into the middle of dentin - Advanced dentin caries. RA5: Radiolucency extending into the inner third of dentin - Severe dentin caries. Participants' answers will be compared to a reference standard. |
Each participant will be assessed over a period of up to 2 months (includes both evaluation phases and washout period)
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Khanagar SB, Al-Ehaideb A, Maganur PC, Vishwanathaiah S, Patil S, Baeshen HA, Sarode SC, Bhandi S. Developments, application, and performance of artificial intelligence in dentistry - A systematic review. J Dent Sci. 2021 Jan;16(1):508-522. doi: 10.1016/j.jds.2020.06.019. Epub 2020 Jun 30.
- Panyarak W, Wantanajittikul K, Suttapak W, Charuakkra A, Prapayasatok S. Feasibility of deep learning for dental caries classification in bitewing radiographs based on the ICCMS radiographic scoring system. Oral Surg Oral Med Oral Pathol Oral Radiol. 2023 Feb;135(2):272-281. doi: 10.1016/j.oooo.2022.06.012. Epub 2022 Jul 2.
- Ayan E, Bayraktar Y, Celik C, Ayhan B. Dental student application of artificial intelligence technology in detecting proximal caries lesions. J Dent Educ. 2024 Apr;88(4):490-500. doi: 10.1002/jdd.13437. Epub 2024 Jan 10.
- Mertens S, Krois J, Cantu AG, Arsiwala LT, Schwendicke F. Artificial intelligence for caries detection: Randomized trial. J Dent. 2021 Dec;115:103849. doi: 10.1016/j.jdent.2021.103849. Epub 2021 Oct 14.
- Laske M, Opdam NJM, Bronkhorst EM, Braspenning JCC, van der Sanden WJM, Huysmans MCDNJM, Bruers JJ. Minimally Invasive Intervention for Primary Caries Lesions: Are Dentists Implementing This Concept? Caries Res. 2019;53(2):204-216. doi: 10.1159/000490626. Epub 2018 Aug 14.
- Ammar N, Kuhnisch J. Diagnostic performance of artificial intelligence-aided caries detection on bitewing radiographs: a systematic review and meta-analysis. Jpn Dent Sci Rev. 2024 Dec;60:128-136. doi: 10.1016/j.jdsr.2024.02.001. Epub 2024 Feb 29.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-18123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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