[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647411":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":58,"collaborators":29,"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":29,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":89,"whyStopped":29,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Kutahya Health Sciences University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"970-nm Diode Laser Frenectomy","EXPERIMENTAL","Participants randomized to this arm will undergo maxillary labial frenectomy using a 970-nm diode laser. The procedure will be performed with a SiroLaser Advance device at 970 nm wavelength, 2 W power, continuous wave mode, and a 320-micrometer sterile fiber tip using a contact technique. The total laser application time will be standardized as 2 minutes. The surgical area will not be sutured and will be left to heal by secondary intention.",[13],"Procedure: 970-nm Diode Laser Frenectomy",{"label":15,"type":10,"description":16,"interventionNames":17},"Liquid Nitrogen Cryotherapy","Participants randomized to this arm will receive liquid nitrogen cryotherapy applied to the maxillary labial frenulum region using an open-spray technique. Two freeze-thaw cycles will be performed; each freezing cycle will last 15 seconds, with passive complete thawing between cycles. No mechanical excision will be performed after cryotherapy. The target tissue is expected to be eliminated through cryogenic necrosis and secondary healing. The surgical area will not be sutured.",[18],"Procedure: Liquid Nitrogen Cryotherapy",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Maxillary labial frenectomy will be performed using a 970-nm diode laser device at 2 W power in continuous wave mode with a 320-micrometer sterile fiber tip using a contact technique. The total laser application time will be standardized as 2 minutes. The surgical area will not be sutured and will be left to heal by secondary intention.",[9],[25],"Diode laser frenectomy",{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Liquid nitrogen cryotherapy will be applied to the maxillary labial frenulum region using an open-spray technique. Two freeze-thaw cycles will be performed; each freezing cycle will last 15 seconds, with passive complete thawing between cycles. No mechanical excision will be performed after cryotherapy, and the surgical area will not be sutured.",[15],null,[31],{"name":32,"affiliation":33,"role":34},"Muhammet Yasin Pektaş, Asst. Prof, DDS","Kutahya Health Sciences University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":29,"email":39},"CONTACT","+905541351195","muhammetyasin.pektas@ksbu.edu.tr",[41],{"facility":42,"status":29,"city":43,"state":43,"zip":44,"country":45,"countryCode":29,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Kutahya Health Sciences University Faculty of Dentistry","Kütahya","43020","Turkey (Türkiye)",{"type":47,"coordinates":48},"Point",[49,50],29.98333,39.42417,{"lat":50,"lon":49},[53,55,57],{"name":54,"role":37,"phone":38,"phoneExt":29,"email":39},"Muhammet Yasin Pektaş, Asst. Prof., DDS",{"name":29,"role":37,"phone":29,"phoneExt":29,"email":56},"mypektas42@gmail.com",{"name":54,"role":34,"phone":29,"phoneExt":29,"email":29},{"type":59,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100647411","970-nm-diode-laser-versus-liquid-nitrogen-cryotherapy-in-maxillary-labial-frenectomy-100647411",false,"NCT07708389","970-nm Diode Laser Versus Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy","Comparison of Salivary Cortisol Response and Early Postoperative Outcomes Following 970-nm Diode Laser and Liquid Nitrogen Cryotherapy in Maxillary Labial Frenectomy: A Randomized Single-Blind Clinical Trial","MLF-DL-KRYO","Inclusion Criteria:\n\n* Age between 18 and 65 years.\n* Systemically healthy, ASA I status.\n* Clinical indication for maxillary labial frenectomy.\n* Ability to attend postoperative follow-up visits.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Systemic or local corticosteroid use within the last 6 months.\n* Endocrine disease that may affect cortisol levels.\n* Pregnancy or lactation.\n* Active oral infection.\n* Chronic analgesic or anti-inflammatory drug use.\n* Psychiatric medication use.\n* Smoking.\n* ASA II or higher systemic status.\n* Inability to attend follow-up visits.\n* Refusal to participate in the study.","ALL","18 Years","65 Years",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"NA","This prospective, randomized, single-blind, assessor-blinded, parallel-group clinical trial aims to compare the effects of 970-nm diode laser and liquid nitrogen cryotherapy in patients requiring maxillary labial frenectomy.\n\nThe primary objective is to compare the change in salivary cortisol levels from baseline to postoperative day 2 between the two treatment groups. Secondary objectives include comparison of postoperative pain, edema, interincisal mouth opening, analgesic consumption, operation duration, state anxiety, clinical wound healing, and adverse events.\n\nEligible adult patients with an indication for maxillary labial frenectomy will be randomly assigned to receive either 970-nm diode laser frenectomy or liquid nitrogen cryotherapy. Salivary cortisol samples and clinical outcomes will be assessed during the early postoperative follow-up period.",[79,80],"Maxillary Labial Frenulum Abnormality","Hypertrophic Maxillary Labial Frenulum",[82,83,84,85,86,87,88],"Maxillary labial frenectomy","Diode laser","970-nm diode laser","Liquid nitrogen cryotherapy","Salivary cortisol","Postoperative pain","Wound healing","NOT_YET_RECRUITING","2026-07-13",{"date":92,"type":93},"2026-07-16","ACTUAL",{"date":95,"type":73},"2026-07-30",{"date":97,"type":73},"2027-05-21",{"name":5,"class":6},1]