[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635837":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":37,"locations":43,"responsibleParty":72,"collaborators":36,"id":75,"slug":36,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":36,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":36,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":46,"whyStopped":36,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University of Medicine and Pharmacy at Ho Chi Minh City","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Diode Laser Group","EXPERIMENTAL","Patients in this group undergo lingual frenectomy using a 940 nm diode laser (Epic X, Biolase). The procedure is performed using a transverse incision technique without suturing. Laser settings include an average power of 1W, peak power of 2W in pulsed mode (CP2), and a 940 nm wavelength.",[13],"Procedure: Lingual Frenectomy using 940nm Diode Laser",{"label":15,"type":16,"description":17,"interventionNames":18},"Electrosurgery Group","ACTIVE_COMPARATOR","Patients in this group undergo lingual frenectomy using a high-frequency electrosurgical unit (ERBE-VIO 100C). The procedure follows the same transverse incision protocol without suturing as the experimental group.",[19],"Procedure: Lingual Frenectomy using High-frequency Electrosurgery",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Lingual Frenectomy using 940nm Diode Laser","Lingual frenectomy performed using a 940 nm Diode Laser (Epic X, Biolase). The laser is set to pulsed mode (CP2), average power 1W, and peak power 2W. The procedure involves a transverse incision to release the frenum without suturing. Protective eyewear is mandatory for the patient and surgical team.",[9],[27,28],"Diode Laser Frenectomy","Laser-assisted Frenotomy",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Lingual Frenectomy using High-frequency Electrosurgery","Lingual frenectomy performed using a high-frequency electrosurgical unit (ERBE-VIO 100C). The procedure follows a standardized transverse incision protocol without suturing. A grounding pad (electrode) is applied to the patient's body to complete the circuit. This serves as the active comparator representing the conventional surgical method at the hospital.",[15],[34,35],"Electrosurgical Frenectomy","Electrocautery Frenotomy",null,[38],{"name":39,"role":40,"phone":41,"phoneExt":36,"email":42},"Phong Dai Lam, PhD, DDS","CONTACT","(+84) 906312958","phonglam@ump.edu.vn",[44,64],{"facility":45,"status":46,"city":47,"state":36,"zip":36,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Children's Hospital 1, Department of Odonto-Stomatology","RECRUITING","Ho Chi Minh City","Vietnam",{"type":50,"coordinates":51},"Point",[52,53],106.62965,10.82302,{"lat":53,"lon":52},[56,60,62],{"name":57,"role":40,"phone":58,"phoneExt":36,"email":59},"Phung Van Ho, DDS","(+84) 983791484","hvphung.ckii.rhm23@ump.edu.vn",{"name":57,"role":61,"phone":36,"phoneExt":36,"email":36},"PRINCIPAL_INVESTIGATOR",{"name":39,"role":63,"phone":36,"phoneExt":36,"email":36},"SUB_INVESTIGATOR",{"facility":65,"status":46,"city":47,"state":36,"zip":36,"country":48,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City",{"type":50,"coordinates":67},[52,53],{"lat":53,"lon":52},[70,71],{"name":39,"role":40,"phone":41,"phoneExt":36,"email":42},{"name":57,"role":63,"phone":36,"phoneExt":36,"email":36},{"type":61,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Phong Dai Lam","Head of Department of Oral and Maxillofacial Radiology, Faculty of Dentistry","100635837",false,"NCT07557875","Healing Efficacy of Diode Laser in Lingual Frenectomy","Evaluation of the Healing Efficacy of Diode Laser in Lingual Frenectomy","Inclusion Criteria:\n\n* Patients aged between 3 and 6 years.\n* Diagnosed with grade 3 or grade 4 ankyloglossia according to Kotlow's classification (1999).\n* Parents or legal guardians provide informed consent for the child to participate in the study.\n* Patients and guardians agree to follow the follow-up schedule (24 hours, 3 days, 1 week, and 1 month post-surgery).\n\nExclusion Criteria:\n\n* History of allergy to local anesthetics (e.g., Lidocaine, Adrenaline).\n* Patients with systemic diseases or high-risk surgical factors (e.g., cardiovascular disease, bleeding disorders, hemophilia, epilepsy, or uncontrolled asthma).\n* Uncooperative patients who are unable to undergo the procedure under local anesthesia or fail to follow post-operative instructions.\n* Patients who withdraw from the study before completion.","ALL","3 Years","6 Years",{"count":85,"type":86},53,"ESTIMATED","INTERVENTIONAL",[89],"NA","This study aims to compare the wound healing efficacy and postoperative experiences between the 940 nm diode laser technique and the traditional electrosurgery method for treating ankyloglossia (tongue-tie) in children aged 3 to 6 years.\n\nParticipants are randomly assigned to one of two groups: Experimental Group - Patients undergo lingual frenectomy using a 940 nm diode laser and Active Comparator Group - Patients undergo the procedure using conventional high-frequency electrosurgery.\n\nThe study evaluates several key outcomes at multiple intervals (24 hours, 3 days, 1 week, and 1 month post-surgery), including: (1) Wound Healing: Measured by the Early Wound Healing Score (EHS); (2) Pain Levels: Assessed using the Wong-Baker FACES Pain Rating Scale; (3) Bleeding Control: Evaluation of intraoperative bleeding; (4) Tongue Mobility: Measurement of free tongue length according to Kotlow's classification.\n\nThe goal is to determine if the diode laser provides superior healing, less pain, and better bleeding control compared to electrosurgery.",[92,93],"Ankyloglossia","Tongue-tie",[92,93,95,96,97,98,99,100,101,102],"Lingual frenectomy","Diode laser","Electrosurgery","Wound healing","Postoperative pain","Early Wound Healing Score (EHS)","Wong-Baker FACES Pain Rating Scale","Kotlow's classification","2026-04-22",{"date":105,"type":106},"2026-04-30","ACTUAL",{"date":108,"type":106},"2024-10-01",{"date":110,"type":86},"2026-10-01",{"name":5,"class":6},2]