NCT07027189

Brief Summary

This study aims to evaluate the influence of artificial intelligence (AI) on the decision-making process for intervention after caries lesion detection. Participants will be dentists working in the Netherlands randomly divided into two groups. Dentists will be divided into two groups and receive a set of bitewing radiographs, which first will be evaluated with or without AI support according to their group. Participants will examine caries lesions on the radiographs and formulate treatment plans accordingly. Then, after a wash-out period of one month, the same radiographs, but in the opposite condition of AI support and again formulate treatment suggestions according to the present caries lesions.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Oct 2025Jun 2026

First Submitted

Initial submission to the registry

May 28, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

October 2, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2026

Last Updated

June 18, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

May 28, 2025

Last Update Submit

June 10, 2025

Conditions

Keywords

Artificial IntelligenceCaries DetectionDecision-makingDental ImagingTreatment Planning

Outcome Measures

Primary Outcomes (1)

  • Treatment decisions: Compare the treatment recommendations of dentists for caries lesions detected with and without AI support.

    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 Outcomes (1)

  • Diagnostic Accuracy in Caries Detection

    Each participant will be assessed over a period of up to 2 months (includes both evaluation phases and washout period)

Study Arms (2)

Phase 1: Caries detection without AI, Phase 2: Caries detection with AI

ACTIVE COMPARATOR

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.

Diagnostic Test: Artificial intelligence in diagnosis

Phase 1: Caries detection with AI, Phase 2: Caries detection without AI

ACTIVE COMPARATOR

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.

Diagnostic Test: Artificial intelligence in diagnosis

Interventions

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.

Phase 1: Caries detection with AI, Phase 2: Caries detection without AIPhase 1: Caries detection without AI, Phase 2: Caries detection with AI

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Graduated, practising dentists.
  • At least three years of experience

You may not qualify if:

  • Retired dentists.
  • Specialized practitioners (e.g., orthodontists and oral surgeons) if their typical practice does not involve routine caries diagnostics and treatment planning.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dentistry Radboud Uniersity Medical Center

Nijmegen, Gelderland, 6525 EX, Netherlands

Location

Related Publications (6)

  • 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.

    PMID: 36513589BACKGROUND
  • 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.

    PMID: 38200405BACKGROUND
  • 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.

    PMID: 34656656BACKGROUND
  • 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.

    PMID: 30107377BACKGROUND
  • 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.

    PMID: 38450159BACKGROUND
  • 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.

    PMID: 33384840BACKGROUND

Related Links

MeSH Terms

Interventions

Artificial IntelligenceDiagnosis

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 18, 2025

Study Start

October 2, 2025

Primary Completion (Estimated)

June 2, 2026

Study Completion (Estimated)

June 2, 2026

Last Updated

June 18, 2025

Record last verified: 2025-05

Locations