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Manual DexterityNCT07097233

The Impact of Virtual Reality Haptic Simulators and Mobile Apps in Endodontic Clinical Practice

A study testing Virtual Reality Haptic Simulator and Mobile app in people with Manual Dexterity and Self-Confidence, run by Saglik Bilimleri Universitesi.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Manual Dexterity, Self-Confidence, Stress Level
What is being tested?
Virtual Reality Haptic Simulator and Mobile app
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
15 Aug 2025to 20 Sep 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).
  • 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).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Sıla Nur Usta, Associate Professor contact

0090 507 279 5558

silandeniz29@gmail.com

Cangül Keskin, Professor contact

0090 541 420 39 09

About this study

Official title: 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

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.

Read the detailed description

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.

To maintain anonymity, each student will be assigned a randomized identification code. The 30 eligible students will be randomly assigned to three groups: Group 1 (VRHS, n=10), Group 2 (Mobile app, n=10), and Group 3 (Control, n=10). Prior to the study, the endodontists will hold a calibration meeting to review the study protocol and standardize instructional methods to minimize variability. All participants will receive a uniform introduction, including a live demonstration of access cavity preparation on maxillary incisors and a concise presentation on the VRHS and mobile apps, delivered by an experienced endodontist. Hands-on sessions will be conducted in small groups of five to promote engagement and ensure personalized supervision.

After the lecture and demonstration, students in Groups 1 and 2 will complete three practice sessions under standardized conditions to gain familiarity with the VRHS and mobile app, respectively. All sessions will be completed within one week, just before the students begin their clinical endodontic training. Following these sessions, a fourth trial will be performed using the respective technologies, during which performance metrics will be systematically recorded.

After completing the training phase, participants will proceed to perform access cavity preparations on randomly pre-assigned patients, following standardized clinical protocols under supervision. Group 3 students will perform clinical procedures without prior VRHS or mobile app training. Appointments will be scheduled to align with the beginning of the clinical internship. All patients will be informed about the study and will provide consent to be treated by students. Patient inclusion criteria will include: (1) ages 18-50 years, systemically healthy; (2) maxillary central/lateral incisors with apical periodontitis and only occlusal cavity; (3) absence of dental malformations; and (4) suitability for rubber dam isolation. Teeth with calcified canals, malformations, prosthetic preparation, prior endodontic treatment, or noncompliant patients will be excluded.

After completing their clinical sessions, students from all groups will perform the training sessions and fourth trial they had not previously experienced, and their respective performance metrics will be recorded.

Performance data from the fourth trial using the VRHS and mobile app will be automatically captured. The quality of clinical access cavity preparations will be assessed using a standardized assessment form, developed by expert endodontists. An independent and blinded evaluator will assess all clinical procedures and will record these as "clinical scores." Students will also perform self-evaluations using the same form, with these recorded as "self-clinical scores." This approach will allow comparison between expert evaluation and student-perceived performance. The clinical duration of access cavity preparation (in minutes) will also be documented.

Students' stress levels will be measured using a visual analog scale (VAS) at four stages: before initial use of VRHS or mobile app (VAS 0), after using the tools (VAS 1), immediately before (VAS 2), and immediately after clinical access preparation (VAS 3). Participants will complete a structured questionnaire to assess self-confidence and perceptions of the clinical training experience.

Being tested
Virtual Reality Haptic Simulator, Mobile app, Control
Keywords
dental education, dental students, educational virtual reality, endodontics, mobile app

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality Haptic SimulatorProcedure or surgery

    Students will use a virtual reality haptic simulator as an adjunct educational tool before treating real patients in the clinical setting.

  • Mobile appProcedure or surgery

    Students will use a mobile app as an adjunct educational tool before treating real patients in the clinical setting.

  • ControlProcedure or surgery

    Students will directly treat real patients without using virtual reality haptic simulator or mobile app.

Study groups in NCT07097233
Study groupRoleWhat they receive
Virtual Reality Haptic SimulatorExperimentalVRHS simulator will be used by dental students before treating a real patients in the endodontic clinical practice.
Receives: Procedure: Virtual Reality Haptic Simulator
Mobile appExperimentalMobile app simulator will be used by dental students before treating a real patients in the endodontic clinical practice.
Receives: Procedure: Mobile app
ControlOtherControl group will directly treat patients in the endodontic clinical practice withot prior exposure to any additional educational models
Receives: Procedure: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Manual dexterity

    Measurements of clinical score and drilling time.

    Measured: through study completion, an average of 1 day

  2. Stress

    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').

    Measured: Baseline and through study completion, an average of 1 day

Secondary outcomes (1)
  1. Self-confidence

    Evaluation of the self confidence of students using a questionnaire that has been created by expert educators

    Measured: through study completion, an average of 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start15 Aug 2025 (estimated)
  3. Primary completion15 Sep 2025 (estimated)
  4. Study completion20 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Students will divided into 3 groups based on the received educational model before conducting endodontic treatment on real patients.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07097233
Sponsor's protocol ID
SBU-GFOD-ENDO-SILANURUSTA-002
Status last verified
Jul 2025
First submitted
8 Jul 2025
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Within the scope of the necessity of protecting the individual information of the students and patients, it is considered that the recorded data will not be shared.

Publications

  • Li Y, Ye H, Wu W, Li J, Zhao X, Liu Y, Zhou Y. Effectiveness and Methodologies of Virtual Reality Dental Simulators for Veneer Tooth Preparation Training: Randomized Controlled Trial. J Med Internet Res. 2025 May 22;27:e63961. doi: 10.2196/63961.

    PubMed 40402564
  • Patil S, Bhandi S, Awan KH, Licari FW, Di Blasio M, Ronsivalle V, Cicciu M, Minervini G. Effectiveness of haptic feedback devices in preclinical training of dental students-a systematic review. BMC Oral Health. 2023 Oct 10;23(1):739. doi: 10.1186/s12903-023-03410-3.

    PubMed 37817151
  • Suebnukarn S, Hataidechadusadee R, Suwannasri N, Suprasert N, Rhienmora P, Haddawy P. Access cavity preparation training using haptic virtual reality and microcomputed tomography tooth models. Int Endod J. 2011 Nov;44(11):983-9. doi: 10.1111/j.1365-2591.2011.01899.x. Epub 2011 May 28.

    PubMed 21623838
  • Bandiaky ON, Loison V, Volteau C, Cretin-Pirolli R, George S, Soueidan A, Le Guehennec L. Benefits of using immersive virtual reality in haptic dental simulation for endodontic access cavity training: A comparative crossover study. Int Endod J. 2026 Jun;59(6):1110-1121. doi: 10.1111/iej.14252. Epub 2025 May 12.

    PubMed 40353716
  • Usta SN, Silva EJNL, Keskin C, Tekkanat H, Liukkonen M, Felszeghy S. A comparison of traditional and virtual reality haptic simulator approaches in preclinical endodontic training: Impacts on skill acquisition, confidence and stress. Int Endod J. 2026 Jun;59(6):1083-1092. doi: 10.1111/iej.14236. Epub 2025 Apr 10.

    PubMed 40207994

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Haptic Simulator and Mobile app in people with Manual Dexterity and Self-Confidence, run by Saglik Bilimleri Universitesi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sıla Nur Usta, Associate Professor (0090 507 279 5558, silandeniz29@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Manual dexterity (time frame: through study completion, an average of 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07097233, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.

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