NCT06513260

Brief Summary

The goal of this clinical trial is to investigate the effectiveness of virtual reality distraction therapy using virtual reality glasses in reducing dental anxiety during the surgical extraction of impacted lower third molar teeth.The main questions it aims to answer are:

  • Is the use of the virtual reality distraction during the procedure effective on perceived pain and anxiety?
  • Evaluation of the effectiveness of the virtual reality distraction based on initial anxiety test scores.
  • Does the use of the virtual reality headset cause difficulties for the clinician in performing the procedure? Patients will undergo anxiety tests before surgery. Pre-operative vital signs will be recorded. The procedure will be performed either with or without virtual reality glasses, according to the randomly assigned groups. Post-operative vital signs will be recorded. At the end of the procedure, all patients will undergo anxiety tests and verbal rating scales.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

July 10, 2024

Last Update Submit

September 4, 2025

Conditions

Keywords

Dental AnxietyImpact MolarVirtual Reality

Outcome Measures

Primary Outcomes (4)

  • Modified Dental Anxiety Scale Scores

    In patients with and without the use of virtual reality glasses, the dental anxiety scale and verbal rating scales evaluating their experience during the treatment will be applied.

    Baseline

  • Heart rate measurements

    In patients with and without the use of virtual reality glasses, heart rate will be monitored before, during, and after the treatment.

    During the operation

  • Blood pressure measurements

    In patients with and without the use of virtual reality glasses, blood pressure will be monitored before, during, and after the treatment.

    During the operation

  • Oxygen saturation measurements

    In patients with and without the use of virtual reality glasses, saturation will be monitored before, during, and after the treatment.

    During the operation

Secondary Outcomes (1)

  • Dentist feedback

    Baseline

Study Arms (2)

Virtual reality application

Application of virtual reality glasses during surgical extraction of impacted lower third molars.

Procedure: Surgical extraction of impacted lower third molars.

No application

No application of virtual reality glasses during surgical extraction of impacted lower third molars.

Procedure: Surgical extraction of impacted lower third molars.

Interventions

Surgical extraction of impacted mandibular third molars in the mesioangular position, according to the Tetsch and Wagner classification

No applicationVirtual reality application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

\- Healthy volunteers

You may qualify if:

  • Being over 18 years old
  • Being systemically healthy
  • Needing surgical extraction treatment of impacted lower third molar (in mesioangular position according to Tetsch and Wagner Classification)
  • Having a score of 11 or higher on the dental anxiety scale

You may not qualify if:

  • History of seizures or convulsive disorders
  • Balance disorders such as nystagmus or vertigo
  • Use of psychotropic medications
  • Undergoing treatment for anxiety
  • Patients with psychiatric disorders
  • Presence of dermatological lesions, especially around the face and eyes
  • Presence of any lesion in the eye that would prevent the use of virtual reality
  • Presence of systemic diseases and medication use contraindicating surgical extraction of impacted teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Science University

Kütahya, 43020, Turkey (Türkiye)

Location

Study Officials

  • Eda İzgi

    Kutahya University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Doctor

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 22, 2024

Study Start

January 1, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations