[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651337":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":54,"collaborators":58,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":82,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Bilecik Seyh Edebali Universitesi","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Behavioral: Virtual Reality-Based Audiovisual Distraction","Procedure: Standard Periodontal Frenectomy",{"label":16,"type":17,"description":18,"interventionNames":19},"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.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Virtual Reality-Based Audiovisual Distraction","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.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Standard Periodontal Frenectomy","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.",[16,9],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Muhammed Emin Kalender, PhD","CONTACT","902282141746","emin.kalender@bilecik.edu.tr",[39],{"facility":40,"status":26,"city":41,"state":41,"zip":42,"country":43,"countryCode":26,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Bilecik Seyh Edebali University Faculty of Dentistry","Bilecik","11100","Turkey (Türkiye)",{"type":45,"coordinates":46},"Point",[47,48],29.97932,40.14192,{"lat":48,"lon":47},[51],{"name":52,"role":35,"phone":53,"phoneExt":26,"email":37},"Muhammed Emin Kalender, DDS, PhD","+902282141746",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Muhammed Emin Kalender","Assistant Professor",[59],{"name":5,"class":6},"100651337","virtual-reality-during-periodontal-frenectomy-100651337",false,"NCT07760987","Virtual Reality During Periodontal Frenectomy","Evaluation of the Effects of Virtual Reality Application on Anxiety, Pain, and Physiological Stress Responses During Periodontal Frenectomy","VRFren","Inclusion Criteria:\n\n* Adults aged 18 to 65 years\n* Classified as American Society of Anesthesiologists physical status I or II\n* Presence of a clinical indication for periodontal frenectomy\n* No previous periodontal surgery experience\n* No previous virtual reality experience\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Visual or hearing impairment that may prevent the use of the virtual reality headset\n* History of claustrophobia\n* History of vertigo\n* Use of analgesic or sedative medication within the last 24 hours\n* Current substance dependence\n* Presence of active infection in the surgical area\n* Current regular use of antidepressants, anxiolytics, antipsychotics, mood stabilizers, sedatives\u002Fhypnotics, or other psychotropic medications","ALL","18 Years","65 Years",{"count":72,"type":73},70,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.\n\nThe main questions it aims to answer are:\n\nDoes 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?\n\nResearchers will compare adults who receive standard periodontal frenectomy with virtual reality-based audiovisual distraction to adults who receive standard periodontal frenectomy without virtual reality.\n\nParticipants will:\n\nComplete 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.\n\nRecord 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.",[79,80,81],"Dental Anxiety","Frenectomy","Virtual Reality","NOT_YET_RECRUITING","2026-08-07",{"date":85,"type":86},"2026-08-12","ACTUAL",{"date":88,"type":73},"2026-09",{"date":90,"type":73},"2027-08",{"name":56,"class":6},1]