[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-submucous-fibrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-submucous-fibrosis":127},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,66,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"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":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Oral Submucous Fibrosis",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52],"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","PRP","NOT_YET_RECRUITING","2025-12-10",{"date":56,"type":57},"2025-12-11","ACTUAL",{"date":59,"type":22},"2026-03",{"date":61,"type":22},"2026-09",{"name":63,"class":64},"Karachi Medical and Dental College","OTHER",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":65},"100574396","phase-3-comparison-of-curcumin-and-intralesional-steroids-in-oral-submucous-fibrosis-100574396","NCT06758739","Comparison of Curcumin and Intralesional Steroids in Oral Submucous Fibrosis","Inclusion Criteria:\n\n* Patients diagnosed with Oral submucous fibrosis in accordance with operational definition.\n* Male \\& Female\n\nExclusion Criteria:\n\n* Patient unable to quit the habit of gutkha, tobacco \\& betel nut chewing\n* Patient With uncontrolled diabetes\n* Patient with chronic kidney disease\n* Pregnant female\n* Patient with untreated malignancy\u002Ftaking immunosuppressant drugs\n* Patient with H\u002FO ORAL SUBMUCOUS FIBROSIS in last months",{"count":73,"type":22},70,[75],"PHASE3","The goal of this clinical trial is to learn if Curcumin is better than Intralesional Steroid Injection for the treatment of oral submucous fibrosis. The main question it aims to answers are:\n\n1. If Curcumin is more effective to improve burning sensation as compared to Intralesional steroid.\n2. Does Curcumin treatment results in better mouth opening versus Intralesional steroid.\n3. Can Curcumin helps to improve tongue protrusion as compared to Intralesional steroids.\n\nParticipants will be:\n\n* Assessed for one month, two month and three month.\n* Burning Sensation will be assessed with visual analogue scale (VAS).\n* Mouth Opening will be measured in mm with ruler.\n* Tongue Protrusion will be assessed with the visual analogue scale (VAS).",[28],[79,28,80,81,82,83],"Potentially Malignant Disorder","Intralesional Steroids","Curcumin","Anti-Inflammatory","Anti-Fibrotic","2025-03-05",{"date":86,"type":57},"2025-03-06",{"date":88,"type":22},"2025-04",{"date":90,"type":22},"2025-10",{"name":92,"class":93},"Services Institute of Medical Sciences, Pakistan","OTHER_GOV",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":17,"minAge":18,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":65},"100565194","effect-of-laser-photobiomodulation-in-improving-mouth-opening-in-oral-submucous-fibrosis-100565194","NCT06639009","Effect of Laser Photobiomodulation in Improving Mouth Opening in Oral Submucous Fibrosis","To Determine and Compare the Adjunctive Effect of Photobiomodulation With 940nm Diode Laser on Maximal Interincisal Mouth Opening Versus Conventional Non-invasive Management in Moderate Oral Submucous Fibrosis: A Patient and Outcome Assessor Blinded, Multiple- Arm, Randomized, Placebo Controlled Clinical Trial","OSMFPBMT","Inclusion Criteria:\n\nSubjects with symptomatic bilateral Moderate≥ 18 years of age Subjects who have had no medical, surgical or physical intervention for OSMF at least three months prior to participation in this study.\n\nSubjects willing to participate in the study\n\n\\-\n\nExclusion Criteria:\n\nSubjects with any other Oral potentially malignant disorders ( Leukoplakia\u002F Oral lichen planus etc ) other than OSMF.\n\nSubjects with OSMF with dysplasia in previous biopsy, suspicious lesion that requires biopsy for histopathological examination Subjects with any current \u002F past history of any malignancies Subjects with any developmental disorders, cranio-maxillomandibular bony pathologies\u002F trauma, current odontogenic \u002F maxillofacial infection or surgeries causing trismus Subjects with uncontrolled systemic diseases, psychiatric disorders o Subjects with open wounds on the sites to be exposed to LASER PBM or to EMG. Subjects with any scars, tattoos, moles, traumatic, ulcerative, pathological skin lesion on facial skin in region of masseter muscle Subjects unwilling to shave facial hair for electromyography. Subjects with history of Autoimmune diseases like Scleroderma, Dermatomyositis, oral vesiculobullous and Behçet's disease Subjects with history of any corticosteroid, immunosuppressive, anti inflammatory ,immune modulating medication in past six months Subjects with Temporomandibular Joint disorders, Cervical spondylosis muscle dystrophy or any neuromuscular disorders Pregnancy\n\n\\-",true,"99 Years",{"count":105,"type":22},315,[25],"This a patient and outcome assessor blinded, multiple arm, randomized placebo controlled clinical trial.\n\nThe goal of the study is to study the adjunctive effect of 940nm laser photobiomodulation therapy (PBMT) in precancerous condition like moderate Oral submucous Fibrosis in increasing the mouth opening. It will also assess the the effect of PBMT on oral burning sensation cheek flexibility, electromyography of bilateral masseter muscle, inflammatory and fibrogenic cytokines and oral health quality of life at baseline and after 1 and 3 months of PBMT.\n\nAdult subjects fulfilling the selection criteria will be prospectively recruited after ethical clearance and informed written consent. They will be randomized into 3 groups in 1:1 :1 distribution\n\nThe three groups are as follows:\n\nGroup A: Photobiomodulation therapy given intraorally on bilateral buccal mucosa and extraorally (sham) with conventional non-invasive management.\n\nGroup B: Photobiomodulation therapy given intraorally (bilateral buccal mucosa) and extraorally (bilateral masseter muscle) with conventional non-invasive management.\n\nGroup C: Sham (Use of laser handpiece with only red guide light and without using the foot pedal which activates the laser)Photobiomodulation therapy(Placebo) (Intraoral and Extraoral) with conventional non-invasive management.\n\nThe conventional non invasive management in Oral submucous fibrosis which all the groups will receive are as follows:\n\nBrief behavioral Tobacco, areca nut and alcohol habit cessation counseling as per WHO 5As and 5Rs technique at baseline and each follow up.\n\nOral prophylaxis Removal of oral irritational factors like sharp teeth, appliances or prosthesis, impacted buccoverted third molars, parafunctional habits Oral hygiene maintenance instructions Oral physiotherapy(Mouth opening and cheek ballooning exercises) Control of systemic conditions (Anemia, Diabetes, hypertension, thyroid disorders) by specialist referral Removal of all predisposing factors for oral candida infection Advocacy for safe sexual practices Nutrition and diet counseling( seasonal and regional food rich in nutrients, vitamins, antioxidants avoidance of spicy \u002Fsour\u002F hot foods and drinks) Regular surveillance for malignant transformation All the outcome parameters will be assessed at baseline and 1 and 3 months after PBMT.",[28],[28,110,111,112,113,114,115,116],"trismus","Burning pain","diode laser","Photobiology","Electromyography","molecular biology","oral health","RECRUITING","2024-10-10",{"date":120,"type":57},"2024-10-15",{"date":122,"type":57},"2024-09-01",{"date":124,"type":22},"2027-12-31",{"name":126,"class":64},"Dr. Shalini Gupta","Oral SubMucous Fibrosis"]