Generative AI-Based Immersive Training for Endodontic Risk Disclosure and Informed Consent Among Dental Students: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Endodontic Risk Disclosure and Informed Consent (RD-IC) Completeness Score
研究概览
简要总结
The objective of this prospective, parallel-group, 1:1 randomized controlled trial is to evaluate the effectiveness of a generative artificial intelligence (AI)-based immersive training program, utilizing the Gemini platform, in improving endodontic risk disclosure and informed consent (RD-IC) quality, communication competence, self-efficacy, and reducing communication anxiety among undergraduate dental students during their clinical clerkship.
Traditional pedagogical methods in dental education, such as case-based learning (CBL) and peer role-playing, often struggle to simulate the high-stakes interpersonal tension and technical complexity involved in specialized endodontic risk disclosure. Complications like instrument separation, pulp floor perforation, and acute flare-ups require clear, empathetic, and legally sound communication. While standardized patients (SPs) are effective, they pose severe logistical and financial constraints for large student cohorts.
To address this gap, 96 fifth-year undergraduate dental students undergoing clinical rotation were recruited and randomly allocated to either the experimental group (1-month generative AI-based immersive training via the Gemini platform) or the control group (1-month conventional case-based learning). The AI intervention provided interactive, real-time conversational simulations across six high-stakes endodontic clinical scenarios, delivering instantaneous, personalized feedback on technical accuracy and empathetic delivery.
The primary outcome evaluated was the RD-IC completeness score. Secondary outcomes included SEGUE communication framework scores, Self-Efficacy in Clinical Communication Scale (SCS) scores, Communication Anxiety Scale (CAS) scores, blinded standardized patient (SP) ratings, user satisfaction, and long-term clinical skill retention assessed at 1-month (T2-1m) and 2-month (T2-2m) post-intervention follow-ups.
详细描述
BACKGROUND AND RATIONALE:
Endodontic treatments-including root canal therapy, retreatment, and periradicular surgery-are technically demanding procedures that carry inherent risks of irreversible complications, such as instrument separation, canal ledging, pulp floor perforation, and acute flare-ups. Effective risk disclosure and informed consent (RD-IC) processes are essential ethical and legal safeguards that ensure patient autonomy, foster collaborative doctor-patient trust, and minimize medicolegal hazards. However, traditional dental education relying on passive lectures or case-based learning (CBL) fails to recreate the real-world psychological pressure and conversational fluidity needed during challenging consultations. Generative AI large language models (LLMs), such as Gemini, offer an innovative, highly scalable "safe-to-fail" platform capable of simulating adaptive patient personas with diverse emotional profiles and health literacy levels.
STUDY DESIGN AND PARTICIPANT RECRUITMENT:
This prospective, parallel-group, 1:1 randomized controlled trial was conducted at the Department of Stomatology, The First Affiliated Hospital of Hunan University of Chinese Medicine, from March to May 2026. The trial protocol strictly adhered to the CONSORT 2010 statement and CONSORT-EHEALTH 2023 extension guidelines, with ethical approval granted by the Institutional Review Board (Ethics File No. MR-43-26-046512).
A total of 96 eligible fifth-year undergraduate dental students in their clinical clerkship who had completed core endodontic didactic courses were enrolled. Participants were randomly assigned via a computer-generated random sequence to either:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the educational nature of the intervention, blinding of students (participants) and instructors (care providers) was not feasible. However, single-blind assessment was enforced: independent faculty outcome assessors and standardized patients (SPs) were fully blinded to participants' group allocations during all evaluation sessions.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fifth-year undergraduate dental students undergoing clinical clerkship at the Department of Stomatology, Hunan University of Chinese Medicine.
- •Completed all core didactic and theoretical courses in endodontics.
- •Entered the early stage of clinical rotation.
- •Provided signed voluntary informed consent to participate in the trial.
排除标准
- •Prior experience with specialized clinical communication simulation or specialized AI communication training.
- •Presence of unavoidable schedule conflicts during the study period.
- •Factors affecting student eligibility to complete the full training and evaluation process.
结局指标
主要结局
Endodontic Risk Disclosure and Informed Consent (RD-IC) Completeness Score
时间窗: Immediately post-intervention (T1, at 1 month after study baseline)
Evaluated via a validated 10-item checklist covering core indications, intraoperative complications, postoperative pain, long-term structural defects, poor prognosis, anatomical variations, sequential treatments, anesthetic allergies, systemic diseases, and poor compliance. Scores range from 0 to 100, with higher scores indicating superior technical accuracy and completeness in risk disclosure.
次要结局
- SEGUE Framework Doctor-Patient Communication Competence Score(Immediately post-intervention (T1, at 1 month after study baseline))
- Clinical Communication Self-Efficacy Scale (SCS) Score(Immediately post-intervention (T1, at 1 month after study baseline))
- Communication Anxiety Scale (CAS) Score(Immediately post-intervention (T1, at 1 month after study baseline))
- Blinded Standardized Patient (SP) Core Clinical Communication Competence Score(Immediately post-intervention (T1, at 1 month after study baseline))
- AI Simulation Teaching Experience Scale Score(Immediately post-intervention (T1, at 1 month after study baseline))
- Long-term Retention Score of Endodontic Risk Disclosure (1-Month Follow-Up)(1-month post-intervention follow-up (T2-1m, at 2 months after study baseline))
- Long-term Retention Score of Endodontic Risk Disclosure (2-Month Follow-Up)(2-month post-intervention follow-up (T2-2m, at 3 months after study baseline))
研究者
Qun li
Associate Chief Physician, Department of Stomatology
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine