[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650870":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":31,"interventions":49,"overallOfficials":20,"centralContacts":20,"locations":64,"responsibleParty":83,"collaborators":20,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":20,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":20,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":20,"overallStatus":67,"whyStopped":20,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Al-Thawra Modern General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":20},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Wound dehiscence rate","Assessed using Wound Dehiscence Severity Score (WDSS) ranging from 0 (Intact, complete structural integrity) to 3 (Complete failure, full-thickness structural separation requiring surgical revision). Higher scores indicate worse outcomes.","At 7 day , 14 day , and 30 day postoperatively",{"measure":14,"description":15,"timeFrame":16},"palatal fistula formation rate","Assessed using Oronasal Fistula Severity \\& Dimension Score (OFSDS) ranging from 0 (Absent, intact palate) to 3 (Major fistula, anatomical defect \\> 5 mm requiring secondary surgical closure). Higher scores indicate worse outcomes","at 3 month postoperatively",{"measure":18,"description":19,"timeFrame":12},"wound healing score","Assessed using Modified Primary Healing Scale (MPHS) ranging from 1 (Optimal Healing) to 4 (Severe Failure). Higher scores indicate worse outcomes.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":27},"TRIPLE",[28,29,30],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR",[32,38,44],{"label":33,"type":34,"description":35,"interventionNames":36},"Standard palatoplasty ( control )","ACTIVE_COMPARATOR","Conventional palatoplasty without biological adjuncts",[37],"Procedure: Standard palatoplasty ( control)",{"label":39,"type":40,"description":41,"interventionNames":42},"Standard palatoplasty + PRF","EXPERIMENTAL","Conventional palatoplasty augmented PRF",[43],"Procedure: Platelet _ Rich Fibrin ( PRF)",{"label":45,"type":40,"description":46,"interventionNames":47},"Standard palatoplasty +Gentamicin- PRF","Conventional palatoplasty augmented with gentamicine - loaded PRF",[48],"Combination Product: gentamicin_ loaded PRF",[50,55,59],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":20},"PROCEDURE","Standard palatoplasty ( control)","Conventional palatoplasty performed without biological adjuncts",[33],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":20},"Platelet _ Rich Fibrin ( PRF)","Conventional palatoplasty augmented with autologous PRF matrix",[39],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":20},"COMBINATION_PRODUCT","gentamicin_ loaded PRF","Conventional palatoplasty augmented with gentamicin \\_ loaded PRF matrix",[45],[65],{"facility":66,"status":67,"city":68,"state":20,"zip":20,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Al_ Thawra General Hospital Authority","RECRUITING","Sanaa","Yemen","YE",{"type":72,"coordinates":73},"Point",[74,75],44.20646,15.35452,{"lat":75,"lon":74},[78],{"name":79,"role":80,"phone":81,"phoneExt":20,"email":82},"SUMYAH Mohammed Abdulwasea, MSc Trainee","CONTACT","+967730129165","deman9038@gamil.com",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Sumyah Mohammed Abdulwasea Saeed","Principal Investigator \u002F Master's Traine in oral and maxillofacial Surgery","100650870","palatoplasty-techniques-using-prf-and-gentamicin-loaded-prf-in-cleft-palate-100650870",false,"NCT07752849","Palatoplasty Techniques Using PRF and Gentamicin-Loaded PRF in Cleft Palate","A Prospective Randomized Clinical Trial Comparing Standard Palatoplasty Alone, Standard Palatoplasty With Platelet-Rich Fibrin (PRF), and Standard Palatoplasty With Gentamicin-Loaded PRF for Unilateral and Bilateral Complete and Incomplete Cleft Palate Cases","Inclusion Criteria:\n\n* Patients presenting with non-syndromic complete or incomplete unilateral or bilateral cleft palate.\n* Scheduled for primary palatoplasty.\n* Age within the specified study range.\n* Informed consent signed by parents or legal guardians.\n\nExclusion Criteria:\n\n* Patients with associated syndromic clefts or major congenital anomalies.\n* Previous history of palatal surgery or failed prior palatoplasty.\n* Bleeding disorders, active systemic infections, or contraindications to surgery or general anesthesia.\n* Patients lost to follow-up or incomplete records.","ALL","3 Months","18 Years",{"count":98,"type":99},90,"ESTIMATED","INTERVENTIONAL",[102],"NA","This prospective, randomized controlled trial evaluates the clinical efficacy of autologous Platelet-Rich Fibrin (PRF) and Gentamicin-Loaded PRF as regenerative and antimicrobial biological adjuncts in primary palatoplasty. A total of 90 pediatric and adolescent patients with unilateral and bilateral complete and incomplete cleft palates will be assigned across three parallel treatment arms: standard palatoplasty alone (control), palatoplasty augmented with standard PRF, and palatoplasty augmented with gentamicin-loaded PRF. The primary objective is to compare quantitative primary mucosal healing scores, wound dehiscence rates, and the incidence of postoperative oronasal fistula formation to determine whether local gentamicin-PRF delivery significantly improves soft-tissue healing and reduces surgical breakdown",[105,106,107,108,109],"Cleft Palate","Unilateral Cleft Palate","Bilateral Cleft Palate","Complete Cleft Palat","Incompelet Cleft Palate","2026-08-05",{"date":112,"type":113},"2026-08-07","ACTUAL",{"date":115,"type":113},"2026-08-01",{"date":117,"type":99},"2028-12",{"name":5,"class":6},1]