The Impact of Artificial Intelligence on Dentists' Decision-Making Process During Caries Detection

NCT ID: NCT07027189

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-02

Study Completion Date

2026-06-02

Brief Summary

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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.

Detailed Description

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This crossover randomized controlled trial evaluates the effect of artificial intelligence (AI) decision support on dentists' treatment planning following caries detection bitewing radiographs. The study targets clinical decision-making processes by assessing how AI influences diagnostic interpretation and subsequent treatment suggestions. Dentists will be randomly assigned into two study arms. Each participant will evaluate a standardized set of digital bitewing radiographs under two conditions: once with AI assistance and once without, separated by a one-month wash-out period to minimize recall bias. The AI tool provides caries detection prompts based on radiographic analysis but does not suggest treatment. The crossover design enables within-subject comparison, controlling for individual diagnostic thresholds. The radiographs remain constant across both phases to isolate the influence of AI support. The study focuses on diagnostic performance and clinical decision outcomes, both with and without AI support. Treatment decisions are categorized into three predefined levels: no treatment, non-invasive treatment (e.g., fluoride application, polishing, sealing), and invasive intervention (i.e., restorative treatment). Diagnostic accuracy is measured against a reference standard and reported in terms of sensitivity and specificity. Caries detection will be classified using a modified International Caries Classification and Management System (ICCMS). This study design allows to quantify AI's impact on diagnostic performance, as well as on potential shifts in treatment approach. The study aims to contribute to evidence-based guidance on the integration of AI tools into clinical dental practice.

Conditions

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Artificial Intelligence (AI) in Diagnosis Artificial Intelligence Supported Image Reviewing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Artificial intelligence in diagnosis

Intervention Type DIAGNOSTIC_TEST

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 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.

Group Type ACTIVE_COMPARATOR

Artificial intelligence in diagnosis

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Artificial intelligence in diagnosis

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Graduated, practising dentists.
2. At least three years of experience

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prime Dental Alliance Eindhoven

UNKNOWN

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Dentistry Radboud Uniersity Medical Center

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Facility Contacts

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Dilek Sezen-Hulsmans, Dentist

Role: primary

00491708975313

Dr. Cenci

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 36513589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38200405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34656656 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30107377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38450159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33384840 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2025-18123

Identifier Type: -

Identifier Source: org_study_id

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