Virtual Reality During Periodontal Frenectomy

NCT07760987 | Not Yet Recruiting

• 2 other identifiers: 2026-18GAP-2026-750
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Anxiety; Frenectomy; Virtual Reality

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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 days 1 to 7

Study Arms (2)

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.

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.

Procedure: Standard Periodontal Frenectomy

Interventions

Virtual Reality-Based Audiovisual Distraction BEHAVIORAL

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.

Virtual Reality Group

Standard Periodontal Frenectomy PROCEDURE

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.

Control Group; Virtual Reality Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammed Emin Kalender: lead
• Bilecik Seyh Edebali Universitesi: collaborator

Study Sites (1)

Bilecik Seyh Edebali University Faculty of Dentistry

Bilecik, Bilecik, 11100, Turkey (Türkiye)

Location

Central Study Contacts

Muhammed Emin Kalender, PhD

CONTACT

902282141746; emin.kalender@bilecik.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and the surgeon/care provider cannot be masked because of the nature of the virtual reality intervention. The 7-day early wound healing assessment will be performed by an outcomes assessor who is blinded to group assignment. The assessor will not be present during surgery, will not access the randomization result, and participants will be instructed not to disclose whether they received virtual reality. Postoperative questionnaires kept in sealed envelopes will be opened only after the blinded wound healing assessment is completed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)