[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614315":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":38,"locations":49,"responsibleParty":74,"collaborators":43,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":43,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":120,"whyStopped":43,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Karachi Medical and Dental College","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Alternating Triamcinolone + PRP Therapy","ACTIVE_COMPARATOR","Patients will receive alternating-week intralesional Triamcinolone (10 mg\u002FmL) and Platelet-Rich Plasma therapy. Triamcinolone is given in Week 1, PRP in Week 2, and alternated weekly for a total of 6-8 sessions.",[13,14],"Biological: Platelet-Rich Plasma (PRP) Injections","Drug: Triamcinolone Acetonide",{"label":16,"type":10,"description":17,"interventionNames":18},"Triamcinolone Alone Therapy","Patients will receive intralesional Triamcinolone acetonide (10 mg\u002FmL) once weekly for 6-8 sessions as standard therapy.",[14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Platelet-Rich Plasma (PRP) Injections","Autologous Platelet-rich plasma (PRP) injected intralesionally at standard volume for Oral submucous fibrosis (OSF) treatment, administered every alternate week.",[9],[26],"PRP",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Triamcinolone Acetonide","Triamcinolone acetonide 10 mg\u002FmL administered intralesionally once weekly.",[9,16],[33],"TA",[35],{"name":36,"affiliation":5,"role":37},"Sufyan Ahmed, BDS, FCPS","STUDY_CHAIR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Madiha Khan, BDS, MS","CONTACT","+923350-250691",null,"Dr.khanmadiha@gmail.com",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Aisha Faraz, BDS, MS","+92333096619","Aishazafar212@gmail.com",[50],{"facility":51,"status":43,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Abbasi Shaheed Hospital","Karachi","Sindh","71510","Pakistan","PK",{"type":58,"coordinates":59},"Point",[60,61],67.0104,24.8608,{"lat":61,"lon":60},[64,67,69,71],{"name":40,"role":41,"phone":65,"phoneExt":43,"email":66},"+923350250691","dr.khanmadiha@gmail.com",{"name":46,"role":41,"phone":68,"phoneExt":43,"email":48},"+923333096619",{"name":40,"role":70,"phone":43,"phoneExt":43,"email":43},"PRINCIPAL_INVESTIGATOR",{"name":72,"role":73,"phone":43,"phoneExt":43,"email":43},"Aisha Zafar, BDS, MS","SUB_INVESTIGATOR",{"type":70,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Madiha Khan","Principal Investigator","100614315","alternating-triamcinolone-and-platelet-rich-plasma-therapy-for-oral-submucous-fibrosis-100614315",false,"NCT07277998","Alternating Triamcinolone and Platelet-Rich Plasma Therapy for Oral Submucous Fibrosis","Clinical Efficacy of Alternating Intralesional Triamcinolone Acetonide and Platelet-Rich Plasma Compared to Triamcinolone Alone in Patients With Oral Submucous Fibrosis: A Two-Arm Interventional Clinical Trial","RegenOSF","Inclusion Criteria:\n\nClinically diagnosed Oral Submucous Fibrosis (OSF), Stage II-IV using Haider et al. classification.\n\nAge 18-65 years. Mouth opening ≤ 30 mm. Persistent burning sensation (VAS ≥ 3). Able and willing to comply with weekly therapy sessions. Provided written informed consent.\n\nExclusion Criteria:\n\nPrevious treatment with PRP, Platelet-rich Fibrin (PRF), corticosteroid, or combination therapy in the last 6 months.\n\nSystemic diseases affecting wound healing (e.g., uncontrolled diabetes, severe anemia).\n\nCurrent steroid therapy or immunosuppressive therapy.\n\nOral lesions suspicious for malignancy or recurrent Oral Squamous cell carcinoma (OSCC).\n\nBleeding disorders or platelet count \\\u003C150,000.\n\nPregnant or breastfeeding women.\n\nKnown allergy to local anesthetics or triamcinolone.\n\nPatients unwilling to stop areca nut\u002Ftobacco habits.","ALL","18 Years","65 Years",{"count":89,"type":90},40,"ESTIMATED","INTERVENTIONAL",[93],"NA","Oral Submucous Fibrosis (OSF) is a chronic, progressive, potentially malignant disorder characterized by mucosal stiffness, trismus, and burning sensation. This interventional clinical trial evaluates the therapeutic effectiveness of alternating weekly intralesional Triamcinolone Acetonide (TA) and Platelet-Rich Plasma (PRP) injections compared to standard Triamcinolone therapy alone. The purpose is to determine whether sequential anti-inflammatory (TA) and regenerative (PRP) stimulation can produce superior clinical improvement in mouth opening, burning sensation, and mucosal flexibility compared to corticosteroid therapy alone.",[96],"Oral Submucous Fibrosis",[98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,26],"Triamcinolone acetonide","Platelet-rich plasma","Regenerative therapy","Oral mucosal disorders","Fibrosis","OSF","Intralesional therapy","Oral and maxillofacial surgery","Steroid injection","Mouth opening","Burning sensation","Oral precancerous lesions","Stem cell mediated healing","Collagen remodeling","Areca nut","Trismus","Limited mouth opening","LMO","BMS","OMFS","Regenerative dentistry","Oral surgery","NOT_YET_RECRUITING","2025-12-10",{"date":123,"type":124},"2025-12-11","ACTUAL",{"date":126,"type":90},"2026-03",{"date":128,"type":90},"2026-09",{"name":5,"class":6},1]