[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650870":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":31,"locations":41,"responsibleParty":60,"collaborators":31,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":31,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":31,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":31,"overallStatus":44,"whyStopped":31,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Al-Thawra Modern General Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard palatoplasty ( control )","ACTIVE_COMPARATOR","Conventional palatoplasty without biological adjuncts",[13],"Procedure: Standard palatoplasty ( control)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard palatoplasty + PRF","EXPERIMENTAL","Conventional palatoplasty augmented PRF",[19],"Procedure: Platelet _ Rich Fibrin ( PRF)",{"label":21,"type":16,"description":22,"interventionNames":23},"Standard palatoplasty +Gentamicin- PRF","Conventional palatoplasty augmented with gentamicine - loaded PRF",[24],"Combination Product: gentamicin_ loaded PRF",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","Standard palatoplasty ( control)","Conventional palatoplasty performed without biological adjuncts",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Platelet _ Rich Fibrin ( PRF)","Conventional palatoplasty augmented with autologous PRF matrix",[15],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"COMBINATION_PRODUCT","gentamicin_ loaded PRF","Conventional palatoplasty augmented with gentamicin \\_ loaded PRF matrix",[21],[42],{"facility":43,"status":44,"city":45,"state":31,"zip":31,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Al_ Thawra General Hospital Authority","RECRUITING","Sanaa","Yemen","YE",{"type":49,"coordinates":50},"Point",[51,52],44.20646,15.35452,{"lat":52,"lon":51},[55],{"name":56,"role":57,"phone":58,"phoneExt":31,"email":59},"SUMYAH Mohammed Abdulwasea, MSc Trainee","CONTACT","+967730129165","deman9038@gamil.com",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"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":75,"type":76},90,"ESTIMATED","INTERVENTIONAL",[79],"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",[82,83,84,85,86],"Cleft Palate","Unilateral Cleft Palate","Bilateral Cleft Palate","Complete Cleft Palat","Incompelet Cleft Palate","2026-08-05",{"date":89,"type":90},"2026-08-07","ACTUAL",{"date":92,"type":90},"2026-08-01",{"date":94,"type":76},"2028-12",{"name":5,"class":6},1]