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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Virtual Reality-Based Audiovisual Distraction
BehavioralParticipants 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/SurgeryAll 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
After local anesthesia, during the middle phase of surgery, and 10 minutes after completion of surgery2
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.
Time frame
Baseline before randomization and virtual reality application, and 10 minutes after completion of surgery3
Blood Pressure During Periodontal Frenectomy
Systolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg) as physiological indicators of stress response.
Time frame
Before virtual reality application, after local anesthesia, during the middle phase of surgery, and immediately after surgery4
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.
Time frame
Baseline before randomization and virtual reality application, after local anesthesia, during the middle phase of surgery, and at completion of surgerySecondary 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.
Time frame
Postoperative days 1 to 7Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Muhammed Emin Kalender
Lead sponsor
Bilecik Seyh Edebali Universitesi
Sponsor institution
Bilecik Seyh Edebali Universitesi
Collaborator
Source ClinicalTrials.gov
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