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Not Yet Recruiting NCT07760987

Virtual Reality During Periodontal Frenectomy

Conditions: Dental Anxiety, Frenectomy, Virtual Reality

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: Muhammed Emin Kalender

Location: Bilecik Seyh Edebali University Faculty of Dentistry Bilecik Bilecik

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07760987). StuddyBuddy aggregates publicly available trial information.