Virtual Reality During Periodontal Frenectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMuhammed Emin Kalender

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Pregnancy or breastfeeding

Visual or hearing impairment that may prevent the use of the virtual reality headset

History of claustrophobia

History of vertigo

Trial design

Treatments tested in this trial

  • Virtual Reality-Based Audiovisual Distraction
  • Standard Periodontal Frenectomy

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Muhammed Emin Kalender

Lead sponsor

Bilecik Seyh Edebali Universitesi

Sponsor institution

Bilecik Seyh Edebali Universitesi

Collaborator