[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658748":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":57,"studyPopulation":48,"armGroups":58,"interventions":71,"overallOfficials":79,"centralContacts":84,"locations":90,"responsibleParty":103,"collaborators":48,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":48,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":48,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":127,"overallStatus":130,"whyStopped":48,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Yuzuncu Yil University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":35,"otherOutcomes":48},[9,13,16,19,22,25,28,32],{"measure":10,"description":11,"timeFrame":12},"Relative IL1B Gene Expression in Gingival Crevicular Fluid","Relative IL1B gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.","Baseline (Day 0) and postoperative Days 3, 7, and 14",{"measure":14,"description":15,"timeFrame":12},"Relative TNF Gene Expression in Gingival Crevicular Fluid","Relative TNF gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.",{"measure":17,"description":18,"timeFrame":12},"Relative IL8 Gene Expression in Gingival Crevicular Fluid","Relative IL8 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.",{"measure":20,"description":21,"timeFrame":12},"Relative FGF2 Gene Expression in Gingival Crevicular Fluid","Relative FGF2 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.",{"measure":23,"description":24,"timeFrame":12},"Relative TGFB1 Gene Expression in Gingival Crevicular Fluid","Relative TGFB1 gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.",{"measure":26,"description":27,"timeFrame":12},"Relative LDHA Gene Expression in Gingival Crevicular Fluid","Relative LDHA gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. Changes over time and differences between the diode laser and conventional scalpel frenectomy groups will be evaluated.",{"measure":29,"description":30,"timeFrame":31},"Postoperative Wound Healing Assessed Using the Landry, Turnbull and Howley Wound Healing Index","Postoperative wound healing will be evaluated using the Landry, Turnbull and Howley Wound Healing Index. Healing will be scored from 1 (very poor healing) to 5 (excellent healing). Scores will be compared between treatment groups and across postoperative follow-up time points.","Postoperative Days 3, 7, and 14",{"measure":33,"description":34,"timeFrame":31},"Postoperative Pain Intensity Assessed Using the Visual Analog Scale","Postoperative pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be compared between treatment groups and across postoperative follow-up time points.",[36,39,42,45],{"measure":37,"description":38,"timeFrame":12},"Relative SOST Gene Expression in Gingival Crevicular Fluid","Relative SOST gene expression in gingival crevicular fluid will be quantified using RT-qPCR. Expression levels will be normalized using GAPDH and ACTB as reference genes. SOST will be evaluated as an exploratory marker of local periodontal-alveolar remodeling following frenectomy.",{"measure":40,"description":41,"timeFrame":31},"Postoperative Analgesic Use","Postoperative analgesic use will be recorded during follow-up. The number of analgesic doses taken by each participant will be documented and compared between the diode laser and conventional scalpel frenectomy groups.",{"measure":43,"description":44,"timeFrame":31},"Postoperative Feeding Difficulty","Feeding difficulty will be assessed using a 0-10 numerical rating scale, where 0 indicates no difficulty with eating and 10 indicates the greatest possible difficulty. Scores will be compared between the diode laser and conventional scalpel frenectomy groups.",{"measure":46,"description":47,"timeFrame":31},"Postoperative Daily Comfort","Daily comfort will be assessed using a 0-10 numerical rating scale, where 0 indicates extreme discomfort and 10 indicates complete comfort. Scores will be compared between the diode laser and conventional scalpel frenectomy groups.",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":52,"primaryPurpose":53,"observationalModel":48,"timePerspective":48,"maskingInfo":54},"RANDOMIZED","PARALLEL","Eligible participants will be randomly allocated in a 1:1 ratio to two parallel treatment groups: diode laser frenectomy or conventional scalpel frenectomy. Clinical and molecular outcomes will be evaluated at baseline and during postoperative follow-up.","TREATMENT",{"masking":55,"maskingDescription":56,"whoMasked":48},"NONE","The study is open-label because the diode laser and conventional scalpel procedures are visibly and technically different, making masking of the treating clinician and participants impractical.","This study is a prospective, randomized, open-label, two-arm, parallel-group clinical trial designed to compare the postoperative clinical and local molecular responses following diode laser and conventional scalpel frenectomy in children.\n\nChildren aged 8-12 years with a clinical indication for maxillary labial frenectomy who meet the eligibility criteria will be randomly allocated in a 1:1 ratio to either the diode laser frenectomy group or the conventional scalpel frenectomy group using computer-generated randomization. Because the two surgical procedures are visibly and technically different, masking of the treating clinician and participants is not feasible.\n\nClinical evaluations will be performed at baseline and during postoperative follow-up. Postoperative pain will be assessed using a 0-10 Visual Analog Scale (VAS), and wound healing will be evaluated using the Landry, Turnbull and Howley Wound Healing Index. Analgesic requirement, feeding difficulty, daily comfort, and other clinical healing findings will also be recorded. Standardized intraoral photographs obtained during follow-up will provide supportive assessment of postoperative wound healing.\n\nGingival crevicular fluid samples will be collected from the gingival sulcus adjacent to the maxillary central incisors at baseline (Day 0) and on postoperative Days 3, 7, and 14. Two sterile paper points will be used at each sampling time point. Samples will be transferred to RNase-free tubes, transported under cold-chain conditions, and stored at -80°C until molecular analysis.\n\nRNA isolation, complementary DNA synthesis, and RT-qPCR analyses will be performed to evaluate gene expression changes related to inflammation, tissue injury, wound healing, and local periodontal-alveolar remodeling. Planned molecular targets include IL1B, TNF, IL8, FGF2, TGFB1, an LDH metabolism-related target gene, and SOST. GAPDH and ACTB will be used as reference genes. SOST will be evaluated as a secondary exploratory marker of local periodontal-alveolar remodeling.\n\nChanges in clinical and molecular outcomes will be evaluated over time and between treatment groups, including assessment of group, time, and group-by-time effects.",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"Diode Laser Frenectomy","EXPERIMENTAL","Children aged 8-12 years assigned to this arm will undergo maxillary labial frenectomy using a diode laser. Clinical evaluations and gingival crevicular fluid sampling will be performed at baseline (Day 0) and on postoperative Days 3, 7, and 14.",[64],"Procedure: Diode Laser Frenectomy",{"label":66,"type":67,"description":68,"interventionNames":69},"Conventional Scalpel Frenectomy","ACTIVE_COMPARATOR","Children aged 8-12 years assigned to this arm will undergo maxillary labial frenectomy using a conventional surgical scalpel. Clinical evaluations and gingival crevicular fluid sampling will be performed at baseline (Day 0) and on postoperative Days 3, 7, and 14.",[70],"Procedure: Conventional Scalpel Frenectomy",[72,76],{"type":73,"name":60,"description":74,"armGroupLabels":75,"otherNames":48},"PROCEDURE","Maxillary labial frenectomy will be performed using a Woodpecker LX16 Plus diode laser under standardized clinical conditions. The procedure will be carried out by the Department of Periodontology. Laser parameters, including wavelength, power, operating mode, fiber diameter, and application technique, will be standardized according to the final study protocol.",[60],{"type":73,"name":66,"description":77,"armGroupLabels":78,"otherNames":48},"Maxillary labial frenectomy will be performed using a conventional surgical scalpel under standardized clinical conditions. The procedure will be carried out by the Department of Periodontology according to the study protocol.",[66],[80],{"name":81,"affiliation":82,"role":83},"Burçin AVCI","Van Yüzüncü Yıl Universityc","PRINCIPAL_INVESTIGATOR",[85],{"name":86,"role":87,"phone":88,"phoneExt":48,"email":89},"Burçin AVCI, DDS","CONTACT","+905359558140","burcinavci@yyu.edu.tr",[91],{"facility":92,"status":48,"city":93,"state":48,"zip":48,"country":94,"countryCode":48,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Van Yüzüncü Yıl University Faculty of Dentistry","Van","Turkey (Türkiye)",{"type":96,"coordinates":97},"Point",[98,99],43.38323,38.49457,{"lat":99,"lon":98},[102],{"name":86,"role":87,"phone":88,"phoneExt":48,"email":89},{"type":83,"investigatorFullName":81,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"Assistant Professor","100658748","diode-laser-versus-conventional-frenectomy-in-children-100658748",false,"NCT07853599","Diode Laser Versus Conventional Frenectomy in Children","Clinical Outcomes and Local Molecular Biomarker Changes in Gingival Crevicular Fluid Following Diode Laser Versus Conventional Frenectomy in Children: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Children aged 8-12 years.\n* Presence of a clinical indication for maxillary labial frenectomy.\n* Systemically healthy.\n* No previous frenulum surgery in the relevant region.\n* Ability to attend scheduled clinical follow-up and gingival crevicular fluid sampling visits.\n* Written informed consent provided by a parent or legal guardian.\n* Age-appropriate assent provided by the child.\n* Adequate cooperation to undergo the planned clinical procedures and gingival crevicular fluid sampling.\n\nExclusion Criteria:\n\n* Presence of a systemic disease or condition that may affect wound healing or inflammatory responses.\n* Active local infection or clinically significant inflammation in the relevant region.\n* Use of systemic antibiotics, anti-inflammatory drugs, or corticosteroids within the previous month.\n* Regular use of medications known to affect wound healing or inflammatory responses.\n* Inadequate cooperation preventing completion of the surgical procedure or gingival crevicular fluid sampling.\n* Absence of parental\u002Flegal guardian consent or child assent.\n* Inability to complete the scheduled follow-up and sampling visits.","ALL","8 Years","12 Years",{"count":116,"type":117},20,"ESTIMATED","INTERVENTIONAL",[120],"NA","This prospective, randomized, open-label, parallel-group clinical trial aims to compare diode laser frenectomy with conventional scalpel frenectomy in children aged 8-12 years with a clinical indication for maxillary labial frenectomy. Participants will be randomly allocated in a 1:1 ratio to undergo either diode laser or conventional scalpel frenectomy. Postoperative pain, wound healing, analgesic requirement, feeding difficulty, and daily comfort will be evaluated during follow-up. Gingival crevicular fluid samples will be collected at baseline and on postoperative Days 3, 7, and 14 to assess local molecular changes associated with inflammation, tissue injury, wound healing, and periodontal-alveolar remodeling using RT-qPCR.",[123,124,125,126],"Frenulum; Hypertrophy","Diode Laser","Frenectomy","RT-PCR",[125,128,129],"Maxillary Labial Frenum","Inflammatory Biomarkers","NOT_YET_RECRUITING","2026-09-26",{"date":133,"type":134},"2026-10-02","ACTUAL",{"date":136,"type":117},"2026-11-01",{"date":138,"type":117},"2027-11-30",{"name":5,"class":6},1]