Virtual RealityNCT06092177
Virtual Reality Distraction in Patients Undergoing Periodontal Surgery
A study testing Periodontal surgery with virtual reality distraction and Periodontal surgery without virtual reality distraction in people with Virtual Reality and Oral Surgery, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled clinical trial is to evaluate the effect of virtual reality technology on anxiety and pain levels in patients undergoing periodontal surgery. Participants will be randomly assigned into test and control groups. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Oral Surgery, Dental Anxiety
- What is being tested?
- Periodontal surgery with virtual reality distraction and Periodontal surgery without virtual reality distraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2022to 2 May 2023
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals over the age of 18
- Systemically healthy patients
- Need for periodontal surgical treatment in the mandibular anterior region
- Scoring 15 or above on the modified dental anxiety scale
Who cannot join
- Having a history of seizures or a convulsive disorder
- Balance disorders such as nystagmus, vertigo
- Use of psychotropic drugs
- Getting treatment for anxiety
- Presence of dermatological lesions on the face, especially around the eyes
- A lesion in the eye that will prevent the use of virtual reality glasses
- Systemic disease and medication use that contraindicate periodontal surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43100
About this study
Official title: Evaluation of Virtual Reality Distraction on Dental Anxiety in Patients Undergoing Periodontal Surgery
The goal of this randomized controlled clinical trial is to evaluate the effect of virtual reality technology on anxiety and pain levels in patients undergoing periodontal surgery.
Participants will be randomly assigned into test and control groups. While the patients in the test group will undergo periodontal surgery with virtual reality distraction, the patients in the control group without distraction. After treatment, the groups will be compared regarding anxiety and pain levels.
- Conditions
- Virtual Reality, Oral Surgery, Dental Anxiety
- Being tested
- Periodontal surgery with virtual reality distraction, Periodontal surgery without virtual reality distraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal surgery with virtual reality distractionProcedure or surgery
Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets
Periodontal surgery without virtual reality distractionProcedure or surgery
Periodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | The group will include patients who undergo periodontal surgery with virtual reality distraction Receives: Procedure: Periodontal surgery with virtual reality distraction |
| Control group | Experimental | The group will include patients who undergo periodontal surgery without virtual reality distraction Receives: Procedure: Periodontal surgery without virtual reality distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
Modified dental anxiety scale where higher scores mean a worse outcome and has a minimum value of 5 and a maximum value of 25
Measured: Preoperative, immediately postoperative
Secondary outcomes (4)
Pain level
Visual analog scale where higher scores mean a worse outcome and has a minimum value of 0 and a maximum value of 10
Measured: Preoperative, immediately postoperative
Systolic blood pressure
Blood pressure will be measured by a sphygmomanometer.
Measured: Preoperative, intraoperative, immediately postoperative
Diastolic blood pressure
Blood pressure will be measured by a sphygmomanometer.
Measured: Preoperative, intraoperative, immediately postoperative
Heart rate
The frequency of the heartbeat measured by the number of contractions of the heart per minute
Measured: Preoperative, intraoperative, immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start2 May 2022
- Primary completion3 Apr 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Gürbüz, Kutahya Health Sciences University
- Investigators
- Ezgi Gurbuz, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092177
- Sponsor's protocol ID
- 03
- Status last verified
- Apr 2022
- First submitted
- 15 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gurbuz E, Gurbuz AA. Investigation of the effect of virtual reality distraction in patients undergoing mandibular periodontal surgery: A randomized controlled study. J Esthet Restor Dent. 2024 May;36(5):813-822. doi: 10.1111/jerd.13203. Epub 2024 Feb 5.
PubMed 38314536
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Virtual Reality Distraction on Dental Anxiety in Patients Undergoing Periodontal Surgery
- ClinicalTrials.gov ID
- NCT06092177
- Acronym / sponsor ID
- 03
- Conditions
- Virtual Reality, Oral Surgery, Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 23 Oct 2023 (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 randomized controlled clinical trial is to evaluate the effect of virtual reality technology on anxiety and pain levels in patients undergoing periodontal surgery.
Participants will be randomly assigned into test and control groups. While the patients in the test group will undergo periodontal surgery with virtual reality distraction, the patients in the control group without distraction. After treatment, the groups will be compared regarding anxiety and pain levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Periodontal surgery with virtual reality distractionThe group will include patients who undergo periodontal surgery with virtual reality distraction |
| Control group | Experimental | Procedure: Periodontal surgery without virtual reality distractionThe group will include patients who undergo periodontal surgery without virtual reality distraction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals over the age of 18
- Systemically healthy patients
- Need for periodontal surgical treatment in the mandibular anterior region
- Scoring 15 or above on the modified dental anxiety scale
Key exclusion criteria (7 listed)
- Having a history of seizures or a convulsive disorder
- Balance disorders such as nystagmus, vertigo
- Use of psychotropic drugs
- Getting treatment for anxiety
- Presence of dermatological lesions on the face, especially around the eyes
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 |
|---|---|---|
| Periodontal surgery with virtual reality distractionPeriodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets | Procedure or surgery | Test group |
| Periodontal surgery without virtual reality distractionPeriodontal surgery to improve gingival contour and eliminate inflamed periodontal pockets | Procedure or surgery | Control group |
Primary outcome
Anxiety level
Time frame: Preoperative, immediately postoperative
Modified dental anxiety scale where higher scores mean a worse outcome and has a minimum value of 5 and a maximum value of 25
4 secondary outcomes
Pain level
Time frame: Preoperative, immediately postoperative
Systolic blood pressure
Time frame: Preoperative, intraoperative, immediately postoperative
Diastolic blood pressure
Time frame: Preoperative, intraoperative, immediately postoperative
Heart rate
Time frame: Preoperative, intraoperative, immediately postoperative
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 23 Oct 2023.
- Derived from this study: PubMed 38314536Gurbuz E, Gurbuz AA. Investigation of the effect of virtual reality distraction in patients undergoing mandibular periodontal surgery: A randomized controlled study. J Esthet Restor Dent. 2024 May;36(5):813-822. doi: 10.1111/jerd.13203. Epub 2024 Feb 5.
- Individual participant dataSharing planned: No
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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.
Ezgi Gurbuz principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal surgery with virtual reality distraction and Periodontal surgery without virtual reality distraction in people with Virtual Reality and Oral Surgery, 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 7 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 23 Oct 2023. 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?
Anxiety level (time frame: Preoperative, immediately postoperative). 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 NCT06092177, which also lists 1 linked publication.
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 23 Oct 2023.