Generative AI-Based Immersive Training for Endodontic Risk Disclosure and Informed Consent Among Dental Students: A Randomized Controlled Trial
| Registry | NCT07731867, acronym GAI-ENDORDIC |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Enrollment | 96 (Actual) |
| Sponsor | The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine (Other) |
| Conditions | Endodontic Diseases, Clinical Communication, Informed Consent |
| Interventions | Generative AI-Based Immersive Training, Conventional Case-Based Learning (Other) |
| Dates | start 2026-03-01, primary completion 2026-04-01, completion 2026-05-31, first posted 2026-07-28, last updated 2026-10-15 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Endodontic Diseases All trials for Clinical Communication All trials of Generative AI-Based Immersive Training All trials of Conventional Case-Based Learning
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.
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:
1. Experimental Group (n=48): Generative AI-based Immersive Training.
2. Control Group (n=48): Conventional Case-Based Learning (CBL).
EDUCATIONAL INTERVENTIONS:
* Experimental Group: Participants completed a 1-month simulation program using the Gemini platform. The curriculum comprised six standardized, high-stakes endodontic clinical scenarios (including acute pain management, instrument separation disclosure, and pulp floor perforation). Students engaged in 10-15 minute adaptive dialogue sessions every 3-4 days. The platform utilized standardized prompt templates to deliver real-time, objective feedback on both technical completeness (risk disclosure) and humanistic communication (empathy, tone, and clarity).
* Control Group: Participants underwent conventional CBL targeting the exact same six endodontic scenarios over the same 1-month duration. Learning involved structured group case discussions, faculty lectures, and standard informed consent document reviews. Both groups had equal access to standard clinical guidelines.
OUTCOME MEASURES AND DATA COLLECTION:
Assessments were conducted at four distinct time points: Baseline (T0), Immediately Post-Intervention (T1), 1-Month Follow-Up (T2-1m), and 2-Month Follow-Up (T2-2m).
1. Primary Outcome: RD-IC Completeness Score, measured via a validated 10-item checklist covering core indications, intraoperative complications, post-op pain, prognosis, alternative plans, and compliance.
2. Secondary Outcomes:
* SEGUE Framework Scores: Assessing systematic communication competence (Set the stage, Elicit info, Give info, Understand perspective, End encounter).
* Communication Self-Efficacy Scale (SCS) Scores: Evaluating confidence across clinical communication domains.
* Communication Anxiety Scale (CAS) Scores: Assessing psychological tension and situational anxiety.
* Blinded Standardized Patient (SP) Global Ratings: External validation of clinical communication performance.
* Training Satisfaction Questionnaire: Evaluating platform authenticity, feedback quality, and user experience.
* Longitudinal Retention: Skill retention and clinical transferability evaluated at T2-1m and T2-2m.
STATISTICAL ANALYSIS:
Data analysis was conducted using SPSS 26.0 following Intention-To-Treat (ITT) and Per-Protocol (PP) principles. Group differences were evaluated using t-tests, Mann-Whitney U tests, chi-square tests, and repeated-measures ANOVA, with Bonferroni corrections applied for multiple comparisons.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental Group | Experimental | Other: Generative AI-Based Immersive Training | Participants received a 1-month generative AI-based immersive training program using the Gemini platform, engaging in standardized interactive simulations of six high-stakes endodontic clinical scenarios with immediate personalized feedback. |
| Control Group | Active comparator | Other: Conventional Case-Based Learning | Participants underwent conventional case-based learning (CBL) targeting the same six endodontic scenarios over 1 month, involving group case discussions, faculty lectures, and standard informed consent reviews. |
Sex: All, ages: 18 Years to 25 Years, accepts healthy volunteers
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| The First Affiliated Hospital of Hunan University of Chinese Medicine | Changsha, Hunan | China |