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NCT Number: NCT07760987

Virtual Reality 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:

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.

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Key information

Conditions

Dental Anxiety Frenectomy Virtual Reality

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bilecik Seyh Edebali University Faculty of Dentistry

Bilecik, 11100, Turkey (Türkiye)

Location contact

Muhammed Emin Kalender, DDS, PhD

CONTACT

[email protected]

+902282141746

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Postoperative Pain Intensity Assessed by Visual Analog Scale

    Time frame: Postoperative days 1 to 7

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammed Emin Kalender, PhD

CONTACT

[email protected]

902282141746

Sponsors and collaborators

Lead sponsor

Muhammed Emin Kalender

Other

Collaborators

  • Bilecik Seyh Edebali Universitesi

Registry information

Official study title

Evaluation of the Effects of Virtual Reality Application on Anxiety, Pain, and Physiological Stress Responses During Periodontal Frenectomy

Acronym: VRFren

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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