The Impact of Virtual Reality Haptic Simulators and Mobile Apps on Manual Competence, Stress Levels, and Self-confidence of Dental Students in Endodontic Clinical Practice: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Manual dexterity
研究概览
简要总结
Endodontics presents unique challenges due to the complexity and precision required in procedures such as access cavity preparation, canal instrumentation, and obturation. In this context, access cavity preparation is widely regarded as a critical step in endodontic treatment, as it facilitates the identification of the main root canal anatomy and enables effective chemomechanical debridement of the root canal system. However, the clinical application of this procedure can be particularly challenging for undergraduate students, as patients requiring endodontic care often present with varying degrees of anatomical complexity and clinical difficulty. These variations increase the of procedural complications. This is evident during the fourth year of dental education, when clinical endodontic training typically begins and students are required to perform their first treatments on patients. Initial attempts are often prone to failure due to limited theoretical knowledge, inadequate operative skills, and elevated stress levels. Therefore, ensuring comprehensive and well-structured preclinical training through the use of innovative educational strategies plays a critical role in both facilitating an effective transition to clinical practice and minimizing the risk of potential mishaps.The integration of virtual reality haptic simulators (VRHS) has shown considerable promise in enhancing the quality of endodontic preclinical education. VRHS provides students with an immersive, interactive environment that closely replicates real clinical scenarios, allowing for the development of tactile perception, fine motor control, and procedural accuracy in a risk-free setting. These simulators also encompass the potential drawbacks, such as a lack of standardized feedback and restricted opportunities for repetitive learning of traditional preclinical educational methods. In addition, through the advancements on the internet and mobile technology, mobile applications have become a game-changing tool for dental education. Mobile apps offer a flexible and self-paced learning environment that can be tailored to individual needs, thereby promoting greater engagement and a more interactive, immersive educational experience. As well as the VRHSs, mobile apps also simulate the clinical scenarios and procedures, providing students with the opportunity to develop and refine their skills within a structured and risk-free educational environment. Although the effectiveness of simulators has been investigated in endodontic preclinical settings using artificial teeth, their potential impact on real clinical performance and outcomes remains largely unexplored. Similarly, the role of mobile apps in endodontic education-particularly their effectiveness at the clinical level-has not been adequately studied.
详细描述
This three-arm randomized clinical study with an allocation ratio of 1:1:1 will be conducted in accordance with the Preferred Reporting Items for Randomized Trials in Endodontics (PRIRATE) 2020 guidelines. The study design was approved by the ethical committee of the University of Health Sciences (Approval No.: 2024-498). The sample size calculation was performed using G*Power 3.1.9.2 software, based on a significance level of 5% (α = 0.05), an effect size of 0.5997, and a statistical power of 80% (1-β = 0.80). The analysis indicated that a minimum of 10 students per group would be required to detect a statistically significant effect.
As part of the study, the VirTeaSy Dental simulator (VirTeaSy Dental©, France) will be utilized. This advanced system will feature an integrated touchscreen and a high-resolution three-dimensional (3D) display to provide detailed visualization of teeth, endodontic instruments, and clinical tools. Positioned beneath the 3D screen, haptic interfaces-including a dental mirror and a 3D mouse-will allow users to engage in a highly interactive and immersive simulation experience. Upon completion of each exercise, the simulator will generate a set of objective performance metrics, including surgery time (total procedure time in seconds), drilling time (duration of handpiece use in seconds), target progress (percentage of the intended area successfully removed), accuracy (percentage of non-targeted area preserved), target volume (volume of the intended area to be removed in mm³), and outside volume (volume of the area that should remain unaltered, in mm³).
As a mobile app, Dental EndoMaster (Dental-Edutec Inc., country) will be employed. This app will offer a unique, interactive 3D learning environment that simulates clinical scenarios using micro-CT-based models of teeth embedded within a virtual oral cavity. Users will be able to manipulate these models freely, with synchronized radiographic views and sectional visualizations that reveal internal anatomical structures. The app will include structured exercises guiding students through key procedures such as access cavity preparation and canal localization. Importantly, it will deliver real-time quantitative feedback on procedural metrics-including orifice estimation (%), adequate extension (%), overextension (%), and depth appropriateness (%)-enabling users to identify errors and monitor their performance.
All 4th-year dental students enrolled in the clinical endodontic training program will be invited to participate in the study. Prior to enrollment, the aims and scope of the study will be clearly communicated. Participants will be screened according to the following inclusion criteria: (1) having undergone similar training in access cavity preparation on extracted human teeth, with equivalent duration and methodology during their 2nd- and 3rd-year preclinical education from the same educator; (2) not having previous experience with the VRHS and/or mobile app; (3) having received the same theoretical lecture in endodontics; (4) not currently using medication for anxiety, depression, or systemic illness; (5) demonstrating at least a moderate level of computer literacy, as assessed by a standardized questionnaire; and (6) possessing baseline knowledge regarding access cavity preparation, determined by a brief theoretical quiz.
A total of 42 volunteer students will be anonymously assessed. Psychological distress and anxiety will be evaluated using the Patient Health Questionnaire-4 (PHQ-4) and the General Health Questionnaire-12 (GHQ-12). The PHQ-4, a validated four-item instrument, will be used to detect symptoms potentially impacting concentration and mood. The GHQ-12, a 12-item scale, will monitor variations in psychological distress throughout the study period. An online pre-evaluation test consisting of 10 multiple-choice questions on incisor access cavity preparation will be administered via the Kahoot platform (https://kahoot.it/), integrating gamification to enhance engagement. Students scoring ≥60 points will be eligible for inclusion. Computer literacy will be assessed using a modified self-assessment tool. Of the initial cohort, 30 students will meet the inclusion criteria and will be enrolled. Written informed consent will be obtained, and demographic data (age, gender) will be collected via a secure electronic form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients who will be treated and the assessor who will assess the clinical scores of the students will be blinded regarding which educational method was used for the students.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for dental students:
- •having undergone similar training in access cavity preparation on extracted human teeth, with equivalent duration and methodology during their 2nd and 3th- years of preclinical education from the same educator
- •not having previous experience regarding the use of VRHS and/or mobile app;
- •having received the same theoretical lecture in endodontics
- •not currently using any medication for anxiety, depression, or systemic illness
- •demonstrating at least a moderate level of computer literacy, as assessed by a standardized questionnaire
- •possessing a baseline knowledge regarding access cavity preparation, determined by a brief theoretical quiz.
- •Inclusion Criteria for included teeth:
- •maxillary central or lateral incisors with apical periodontitis and only occlusal cavity
- •teeth with absence of any dental malformations
- •teeth suitable for rubber dam isolation.
排除标准
- •for dental students:
- •Prior experience using virtual reality haptic simulators (VRHS) or the Dental EndoMaster mobile application
- •Inconsistent or insufficient preclinical training in access cavity preparation (e.g., trained by a different educator, different duration or methodology).
- •Did not attend or receive the same theoretical endodontics lecture as peers.
- •Currently taking medications for anxiety, depression, or systemic illnesses that may affect cognitive or motor function.
- •Demonstrating low computer literacy, as determined by a standardized self-assessment tool.
- •Failing to achieve the minimum required score (e.g., <60 points) on the theoretical quiz about access cavity preparation.
- •Refusal to provide informed consent or incomplete demographic/evaluation forms.
- •Previous clinical experience in endodontics (e.g., performing real access cavity preparations on patients prior to the study).
- •Exclusion Criteria for teeth:
- •Teeth other than maxillary central or lateral incisors (e.g., molars, premolars, mandibular teeth)
- •Presence of extensive caries beyond occlusal cavity, restorations, or prosthetic crowns.
- •History of previous endodontic treatment in the selected tooth.
- •Dental malformations, such as dens invaginatus, dens evaginatus, or root anomalies.
- •Calcified canals or limited canal visibility on radiographs
- •Teeth not suitable for rubber dam isolation
- •Patients with systemic diseases (e.g., immunocompromised, uncontrolled diabetes)
- •Patients who are noncompliant, do not consent to student treatment, or express discomfort with participation in the study
- •Pregnant or breastfeeding patients (optional, depending on ethical standards).
研究组 & 干预措施
Virtual Reality Haptic Simulator
VRHS simulator will be used by dental students before treating a real patients in the endodontic clinical practice.
干预措施: Virtual Reality Haptic Simulator (Procedure)
Mobile app
Mobile app simulator will be used by dental students before treating a real patients in the endodontic clinical practice.
干预措施: Mobile app (Procedure)
Control
Control group will directly treat patients in the endodontic clinical practice withot prior exposure to any additional educational models
干预措施: Control (Procedure)
结局指标
主要结局
Manual dexterity
时间窗: through study completion, an average of 1 day
Measurements of clinical score and drilling time.
Stress
时间窗: Baseline and through study completion, an average of 1 day
Measurements of stress levels using VAS scale. This scale consists of a 10cm line, with two end points representing 0 ('no stress') and 10 ('stress as bad as it could possibly be').
次要结局
- Self-confidence(through study completion, an average of 1 day)
研究者
Sıla Nur Usta
Professor (Associate)
Saglik Bilimleri Universitesi