[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614315":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":37,"studyPopulation":29,"armGroups":38,"interventions":50,"overallOfficials":65,"centralContacts":69,"locations":79,"responsibleParty":104,"collaborators":29,"id":107,"slug":29,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":29,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":149,"whyStopped":29,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Karachi Medical and Dental College","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":29},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Mouth Opening (Interincisal Distance in mm)","Mouth opening will be measured using a digital caliper from incisal edge to incisal edge at baseline and at each follow-up visit. The primary endpoint is the change in interincisal distance from baseline to 8 weeks and 12 weeks.","Baseline, Week 4, Week 8, Week 12",{"measure":14,"description":15,"timeFrame":12},"Change in Burning Sensation (VAS Score 0-10)","Burning sensation will be assessed using the Visual Analog Scale (VAS), where 0 indicates no burning and 10 indicates the worst possible burning.",[17,21,25],{"measure":18,"description":19,"timeFrame":20},"Change in Clinical Grade of OSMF","Oral Submucous Fibrosis (OSF) severity will be assessed using a standardized clinical grading system that evaluates mouth opening, fibrous banding, mucosal texture, and burning sensation. Grades range from Grade I (mild) to Grade IV (severe). Higher grades indicate more advanced disease. Improvement or worsening will be determined by comparing baseline and Week 12 assessment","Baseline and Week 12",{"measure":22,"description":23,"timeFrame":24},"Change in Cheek Flexibility (mm)","Cheek flexibility will be measured using Mathur and Jha method at baseline and follow-up visits.","Baseline, Week 8, Week 12",{"measure":26,"description":27,"timeFrame":28},"Incidence of Treatment-Related Adverse Events","All adverse events such as swelling, pain, ulceration, infection, or allergy will be recorded throughout the study period.","Up to 12 weeks",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"RANDOMIZED","PARALLEL","Two-arm parallel assignment comparing alternating-week Triamcinolone + PRP therapy vs standard single-agent therapy","TREATMENT",{"masking":36,"maskingDescription":29,"whoMasked":29},"NONE","Oral Submucous Fibrosis (OSF) is a chronic, irreversible fibro-elastic disorder of the oral mucosa associated with restricted mouth opening, burning sensation, impaired mastication, and decreased quality of life. Traditional management approaches include intralesional corticosteroids, physiotherapy, antioxidants, and more recently, regenerative therapies such as Platelet-Rich Plasma (PRP).\n\nTriamcinolone Acetonide (TA) provides anti-inflammatory and anti-fibrotic effects by suppressing fibroblast activity and collagen deposition. PRP, an autologous concentrate of platelets and growth factors, has demonstrated potential in promoting angiogenesis, collagen remodeling, and mucosal regeneration. Alternating TA and PRP may theoretically combine the immediate anti-inflammatory benefits of TA with the long-term regenerative benefits of PRP, resulting in more effective improvement of OSF symptoms.\n\nThis study consists of two arms. In the control arm, participants will receive weekly intralesional Triamcinolone injections for 6 weeks. In the experimental arm, participants will receive Triamcinolone in Week 1, PRP in Week 2, followed by alternating TA and PRP injections for a total of 6 weeks. All participants will be instructed to perform standardized jaw physiotherapy exercises during the study period.\n\nPrimary outcomes include change in interincisal mouth opening (millimeters) and reduction in burning sensation using a Visual Analog Scale (VAS). Secondary outcomes include mucosal flexibility score, cheek rigidity grading, functional improvement during mastication and speech, and patient satisfaction.\n\nThis clinical trial aims to generate high-quality comparative evidence regarding whether an alternating TA-PRP protocol offers superior therapeutic outcomes compared to conventional corticosteroid therapy alone, thereby supporting advancement of regenerative treatment protocols for OSF within oral and maxillofacial clinical practice.",[39,46],{"label":40,"type":41,"description":42,"interventionNames":43},"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.",[44,45],"Biological: Platelet-Rich Plasma (PRP) Injections","Drug: Triamcinolone Acetonide",{"label":47,"type":41,"description":48,"interventionNames":49},"Triamcinolone Alone Therapy","Patients will receive intralesional Triamcinolone acetonide (10 mg\u002FmL) once weekly for 6-8 sessions as standard therapy.",[45],[51,58],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"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.",[40],[57],"PRP",{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"DRUG","Triamcinolone Acetonide","Triamcinolone acetonide 10 mg\u002FmL administered intralesionally once weekly.",[40,47],[64],"TA",[66],{"name":67,"affiliation":5,"role":68},"Sufyan Ahmed, BDS, FCPS","STUDY_CHAIR",[70,75],{"name":71,"role":72,"phone":73,"phoneExt":29,"email":74},"Madiha Khan, BDS, MS","CONTACT","+923350-250691","Dr.khanmadiha@gmail.com",{"name":76,"role":72,"phone":77,"phoneExt":29,"email":78},"Aisha Faraz, BDS, MS","+92333096619","Aishazafar212@gmail.com",[80],{"facility":81,"status":29,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Abbasi Shaheed Hospital","Karachi","Sindh","71510","Pakistan","PK",{"type":88,"coordinates":89},"Point",[90,91],67.0104,24.8608,{"lat":91,"lon":90},[94,97,99,101],{"name":71,"role":72,"phone":95,"phoneExt":29,"email":96},"+923350250691","dr.khanmadiha@gmail.com",{"name":76,"role":72,"phone":98,"phoneExt":29,"email":78},"+923333096619",{"name":71,"role":100,"phone":29,"phoneExt":29,"email":29},"PRINCIPAL_INVESTIGATOR",{"name":102,"role":103,"phone":29,"phoneExt":29,"email":29},"Aisha Zafar, BDS, MS","SUB_INVESTIGATOR",{"type":100,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Madiha Khan","Principal Investigator","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":118,"type":119},40,"ESTIMATED","INTERVENTIONAL",[122],"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.",[125],"Oral Submucous Fibrosis",[127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,57],"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":152,"type":153},"2025-12-11","ACTUAL",{"date":155,"type":119},"2026-03",{"date":157,"type":119},"2026-09",{"name":5,"class":6},1]