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临床试验/NCT07027189
NCT07027189尚未招募不适用

DECIDE-AI:The Impact of Artificial Intelligence on Dentists' Decision-Making Process During Caries Detection: A Randomized Controlled Study

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
1
主要终点
Treatment decisions: Compare the treatment recommendations of dentists for caries lesions detected with and without AI support.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Artificial intelligence in diagnosis (Diagnostic Test)

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.

干预措施: Artificial intelligence in diagnosis (Diagnostic Test)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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