Dental AnxietyVRFrenNCT07760987
Virtual Reality During Periodontal Frenectomy
A study testing Virtual Reality-Based Audiovisual Distraction and Standard Periodontal Frenectomy in people with Dental Anxiety and Frenectomy, run by Muhammed Emin Kalender at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether virtual reality can reduce anxiety, pain, and physiological stress responses during periodontal frenectomy in adults who need this surgical procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dental Anxiety, Frenectomy, Virtual Reality
- What is being tested?
- Virtual Reality-Based Audiovisual Distraction and Standard Periodontal Frenectomy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to Aug 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years
- Classified as American Society of Anesthesiologists physical status I or II
- Presence of a clinical indication for periodontal frenectomy
- No previous periodontal surgery experience
- No previous virtual reality experience
Who cannot join
- Pregnancy or breastfeeding
- Visual or hearing impairment that may prevent the use of the virtual reality headset
- History of claustrophobia
- History of vertigo
- Use of analgesic or sedative medication within the last 24 hours
- Current substance dependence
- Presence of active infection in the surgical area
- Current regular use of antidepressants, anxiolytics, antipsychotics, mood stabilizers, sedatives/hypnotics, or other psychotropic medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bilecik Seyh Edebali University Faculty of Dentistry
Bilecik, Bilecik, 11100
Muhammed Emin Kalender, DDS, PhD, +902282141746, emin.kalender@bilecik.edu.tr
About this study
Official title: Evaluation of the Effects of Virtual Reality Application on Anxiety, Pain, and Physiological Stress Responses During Periodontal Frenectomy
The goal of this clinical trial is to learn whether virtual reality can reduce anxiety, pain, and physiological stress responses during periodontal frenectomy in adults who need this surgical procedure.
The main questions it aims to answer are:
Read more
Does virtual reality reduce anxiety before and after periodontal frenectomy? Does virtual reality reduce pain during and after the procedure? Does virtual reality have a favorable effect on physiological stress responses such as blood pressure, heart rate, and oxygen saturation? Does virtual reality affect surgical process-related outcomes and early wound healing?
Researchers will compare adults who receive standard periodontal frenectomy with virtual reality-based audiovisual distraction to adults who receive standard periodontal frenectomy without virtual reality.
Participants will:
Complete anxiety and pain questionnaires before the procedure. Undergo periodontal frenectomy under local anesthesia. Be randomly assigned to either the virtual reality group or the control group. Have blood pressure, heart rate, oxygen saturation, and pain levels recorded at defined time points during the procedure.
Record daily pain levels and analgesic use for 7 days after surgery. Return for a 7-day follow-up visit for suture removal and early wound healing assessment.
- Conditions
- Dental Anxiety, Frenectomy, Virtual Reality
- Being tested
- Virtual Reality-Based Audiovisual Distraction, Standard Periodontal Frenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based Audiovisual DistractionBehavioural
Participants assigned to the virtual reality group will use a Meta Quest 3 head-mounted device during periodontal frenectomy. A standardized nature video with calming audio will be presented from before local anesthesia until completion of the surgical procedure. The content will be shown from the same starting point with the same brightness and volume settings for all participants. Participants will watch the content passively without interaction.
Standard Periodontal FrenectomyProcedure or surgery
All participants will undergo clinically indicated periodontal frenectomy under local anesthesia using a standardized surgical protocol. The procedure will be performed by the same surgeon under standardized clinical conditions.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Participants in this group will receive standard periodontal frenectomy under local anesthesia with virtual reality-based audiovisual distraction during the procedure. After baseline assessments and randomization, a Meta Quest 3 head-mounted virtual reality device will be placed before local anesthesia. Participants will passively watch a standardized nature video with calming audio until the surgical procedure is completed. Receives: Behavioral: Virtual Reality-Based Audiovisual Distraction; Procedure: Standard Periodontal Frenectomy |
| Control Group | Active comparator | Participants in this group will receive standard periodontal frenectomy under local anesthesia without virtual reality or any other audiovisual distraction method. The surgical protocol, surgeon, local anesthesia protocol, and clinical environment will be the same as in the virtual reality group. Receives: Procedure: Standard Periodontal Frenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Assessed by Visual Analog Scale During and Immediately After Surgery
Pain intensity will be assessed using a 0 to 10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain will be recorded after local anesthesia, during the middle phase of surgery, and 10 minutes after completion of surgery.
Measured: After local anesthesia, during the middle phase of surgery, and 10 minutes after completion of surgery
State Anxiety Score Assessed by the State-Trait Anxiety Inventory-State Form
State anxiety will be assessed using the State-Trait Anxiety Inventory-State Form (STAI-S). The STAI-S consists of 20 items scored from 1 to 4, with a total score ranging from 20 to 80. Higher scores indicate higher state anxiety.
Measured: Baseline before randomization and virtual reality application, and 10 minutes after completion of surgery
Blood Pressure During Periodontal Frenectomy
Systolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg) as physiological indicators of stress response.
Measured: Before virtual reality application, after local anesthesia, during the middle phase of surgery, and immediately after surgery
Heart Rate During Periodontal Frenectomy
Heart rate will be measured as beats per minute using pulse oximetry. Heart rate will be used as a physiological indicator of stress response.
Measured: Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery
Peripheral Oxygen Saturation During Periodontal Frenectomy
Peripheral oxygen saturation will be measured as percentage using pulse oximetry. Peripheral oxygen saturation will be used as a physiological indicator of stress response.
Measured: Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery
Secondary outcomes (1)
Postoperative Pain Intensity Assessed by Visual Analog Scale
Postoperative pain intensity will be assessed daily using a 0 to 10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Measured: Postoperative days 1 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: a virtual reality group receiving standard periodontal frenectomy with virtual reality-based audiovisual distraction, or a control group receiving standard periodontal frenectomy without virtual reality. Each participant will remain in the assigned group throughout the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammed Emin Kalender
- Sponsor type
- University, hospital or other
- Collaborators
- Bilecik Seyh Edebali Universitesi
- Responsible party
- Sponsor-investigator, Muhammed Emin Kalender, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760987
- Sponsor's protocol ID
- 2026-18
- Other IDs
- GAP-2026-750
- Acronym
- VRFren
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Virtual Reality Application on Anxiety, Pain, and Physiological Stress Responses During Periodontal Frenectomy
- ClinicalTrials.gov ID
- NCT07760987
- Acronym / sponsor ID
- VRFren / 2026-18
- Conditions
- Dental Anxiety, Frenectomy, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Muhammed Emin KalenderUniversity, hospital or other
- Collaborators
- Bilecik Seyh Edebali Universitesi
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 12 Aug 2026 (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 learn whether virtual reality can reduce anxiety, pain, and physiological stress responses during periodontal frenectomy in adults who need this surgical procedure.
The main questions it aims to answer are:
Does virtual reality reduce anxiety before and after periodontal frenectomy? Does virtual reality reduce pain during and after the procedure? Does virtual reality have a favorable effect on physiological stress responses such as blood pressure, heart rate, and oxygen saturation? Does virtual reality affect surgical process-related outcomes and early wound healing?
Researchers will compare adults who receive standard periodontal frenectomy with virtual reality-based audiovisual distraction to adults who receive standard periodontal frenectomy without virtual reality.
Participants will:
Complete anxiety and pain questionnaires before the procedure. Undergo periodontal frenectomy under local anesthesia. Be randomly assigned to either the virtual reality group or the control group. Have blood pressure, heart rate, oxygen saturation, and pain levels recorded at defined time points during the procedure.
Record daily pain levels and analgesic use for 7 days after surgery. Return for a 7-day follow-up visit for suture removal and early wound healing assessment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: a virtual reality group receiving standard periodontal frenectomy with virtual reality-based audiovisual distraction, or a control group receiving standard periodontal frenectomy without virtual reality. Each participant will remain in the assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Behavioral: Virtual Reality-Based Audiovisual Distraction, Procedure: Standard Periodontal FrenectomyParticipants in this group will receive standard periodontal frenectomy under local anesthesia with virtual reality-based audiovisual distraction during the procedure. After baseline assessments and randomization, a Meta Quest 3 head-mounted virtual reality device will be placed before local anesthesia. Participants will passively watch a standardized nature video with calming audio until the surgical procedure is completed. |
| Control Group | Active comparator | Procedure: Standard Periodontal FrenectomyParticipants in this group will receive standard periodontal frenectomy under local anesthesia without virtual reality or any other audiovisual distraction method. The surgical protocol, surgeon, local anesthesia protocol, and clinical environment will be the same as in the virtual reality group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years
- Classified as American Society of Anesthesiologists physical status I or II
- Presence of a clinical indication for periodontal frenectomy
- No previous periodontal surgery experience
- No previous virtual reality experience
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding
- Visual or hearing impairment that may prevent the use of the virtual reality headset
- History of claustrophobia
- History of vertigo
- Use of analgesic or sedative medication within the last 24 hours
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 |
|---|---|---|
| Virtual Reality-Based Audiovisual DistractionParticipants assigned to the virtual reality group will use a Meta Quest 3 head-mounted device during periodontal frenectomy. A standardized nature video with calming audio will be presented from before local anesthesia until completion of the surgical procedure. The content will be shown from the same starting point with the same brightness and volume settings for all participants. Participants will watch the content passively without interaction. | Behavioural | Virtual Reality Group |
| Standard Periodontal FrenectomyAll participants will undergo clinically indicated periodontal frenectomy under local anesthesia using a standardized surgical protocol. The procedure will be performed by the same surgeon under standardized clinical conditions. | Procedure or surgery | Control Group, Virtual Reality Group |
Primary outcome
Pain Intensity Assessed by Visual Analog Scale During and Immediately After Surgery
Time frame: After local anesthesia, during the middle phase of surgery, and 10 minutes after completion of surgery
Pain intensity will be assessed using a 0 to 10 visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain will be recorded after local anesthesia, during the middle phase of surgery, and 10 minutes after completion of surgery.
State Anxiety Score Assessed by the State-Trait Anxiety Inventory-State Form
Time frame: Baseline before randomization and virtual reality application, and 10 minutes after completion of surgery
State anxiety will be assessed using the State-Trait Anxiety Inventory-State Form (STAI-S). The STAI-S consists of 20 items scored from 1 to 4, with a total score ranging from 20 to 80. Higher scores indicate higher state anxiety.
Blood Pressure During Periodontal Frenectomy
Time frame: Before virtual reality application, after local anesthesia, during the middle phase of surgery, and immediately after surgery
Systolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg) as physiological indicators of stress response.
Heart Rate During Periodontal Frenectomy
Time frame: Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery
Heart rate will be measured as beats per minute using pulse oximetry. Heart rate will be used as a physiological indicator of stress response.
Peripheral Oxygen Saturation During Periodontal Frenectomy
Time frame: Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgery
Peripheral oxygen saturation will be measured as percentage using pulse oximetry. Peripheral oxygen saturation will be used as a physiological indicator of stress response.
1 secondary outcome
Postoperative Pain Intensity Assessed by Visual Analog Scale
Time frame: Postoperative days 1 to 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Based Audiovisual Distraction and Standard Periodontal Frenectomy in people with Dental Anxiety and Frenectomy, run by Muhammed Emin Kalender 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 5 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: opening soon, as of the sponsor's last update on 12 Aug 2026. 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?
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 Muhammed Emin Kalender, PhD (902282141746, emin.kalender@bilecik.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Assessed by Visual Analog Scale During and Immediately After Surgery (time frame: After local anesthesia, during the middle phase of surgery, and 10 minutes after completion of surgery). The study lists 5 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 12 Aug 2026.