Dental AnxietyNCT06513260
Effect of Virtual Reality Distraction on Anxiety Control During Impacted Molar Tooth Surgery
An observational study of Dental Anxiety and Impact Molar, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Impact Molar, Virtual Reality
- What is being tested?
- Surgical extraction of impacted lower third molars.
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - Healthy volunteers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Science University
Kütahya, 43020
About this study
Official title: Evaluation of the Effect of Virtual Reality Distraction on Controlling Dental Anxiety During the Surgical Extraction of Impacted Lower Third Molar Teeth
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?
Read more
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.
- Conditions
- Dental Anxiety, Impact Molar, Virtual Reality
- Being tested
- Surgical extraction of impacted lower third molars.
- Keywords
- Dental Anxiety, Impact Molar, Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical extraction of impacted lower third molars.Procedure or surgery
Surgical extraction of impacted mandibular third molars in the mesioangular position, according to the Tetsch and Wagner classification
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality application | Application of virtual reality glasses during surgical extraction of impacted lower third molars. Receives: Procedure: Surgical extraction of impacted lower third molars. | |
| No application | No application of virtual reality glasses during surgical extraction of impacted lower third molars. Receives: Procedure: Surgical extraction of impacted lower third molars. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the operation
Secondary outcomes (1)
Dentist feedback
Verbal rating scales will be applied to the dentist to evaluate the potential difficulties associated with the use of virtual reality distraction.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Jan 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EDA İZGİ, Kutahya Health Sciences University
- Investigators
- Eda İzgi, Principal investigator, Kutahya University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513260
- Sponsor's protocol ID
- KutahyaHSU/Edaİzgi/001
- Status last verified
- Sep 2025
- First submitted
- 10 Jul 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Virtual Reality Distraction on Controlling Dental Anxiety During the Surgical Extraction of Impacted Lower Third Molar Teeth
- ClinicalTrials.gov ID
- NCT06513260
- Acronym / sponsor ID
- KutahyaHSU/Edaİzgi/001
- Conditions
- Dental Anxiety, Impact Molar, Virtual Reality
- Keywords
- Dental Anxiety, Impact Molar, Virtual Reality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality application | – | Procedure: Surgical extraction of impacted lower third molars.Application of virtual reality glasses during surgical extraction of impacted lower third molars. |
| No application | – | Procedure: Surgical extraction of impacted lower third molars.No application of virtual reality glasses during surgical extraction of impacted lower third molars. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - Healthy volunteers
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical extraction of impacted lower third molars.Surgical extraction of impacted mandibular third molars in the mesioangular position, according to the Tetsch and Wagner classification | Procedure or surgery | No application, Virtual reality application |
Primary outcome
Modified Dental Anxiety Scale Scores
Time frame: Baseline
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.
Heart rate measurements
Time frame: During the operation
In patients with and without the use of virtual reality glasses, heart rate will be monitored before, during, and after the treatment.
Blood pressure measurements
Time frame: During the operation
In patients with and without the use of virtual reality glasses, blood pressure will be monitored before, during, and after the treatment.
Oxygen saturation measurements
Time frame: During the operation
In patients with and without the use of virtual reality glasses, saturation will be monitored before, during, and after the treatment.
1 secondary outcome
Dentist feedback
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eda İzgi principal investigator
Kutahya University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Anxiety and Impact Molar, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Dental Anxiety Scale Scores (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2025.