[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dr. Shalini Gupta\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100627810","phase-3-comparison-of-topical-photodynamic-therapy-with-topical-calcipotriol-in-management-of-oral-leukoplakia-100627810",false,"NCT07453472","Comparison of Topical Photodynamic Therapy With Topical Calcipotriol in Management of Oral Leukoplakia","Comparative Evaluation of the Effect of Topical Photodynamic Therapy Versus Topical Calcipotriol on the Clinical and Molecular Characteristics of Oral Leukoplakia: a Randomized Clinical Trial","PDT CALCI HOL","Inclusion Criteria:\n\n* All diagnosed cases of Oral Leukoplakia with size ≥ 2 cm2 (Van der Waal classification ≥ L2) reporting to the department of OMR, CDER and willing to participate in the study will be included\n* Subjects clinically and histologically diagnosed as Oral Leukoplakia.\n* Subjects \\> 18 years of age.\n* Subjects willing to participate in the study and to complete the treatment sessions.\n\nExclusion Criteria:\n\n* History of any topical and\u002For systemic therapy for Oral Leukoplakia other than general management in last 2 months.\n* Subjects with current or past history of malignancy.\n* Subjects with any lesion suspicious of malignancy requiring biopsy.\n* Subjects with severe dysplasia and carcinoma in situ on biopsy of oral lesion\n* Subjects with history of hyperphotosensitivity (genetic disorders, dermatological conditions, drug induced, systemic conditions)\n* Subjects with calcium, Vit D metabolic and parathyroid disorders\n* Pregnant and lactating females.","ALL","18 Years","99 Years",{"count":21,"type":22},166,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","(i)Rationale\u002F gaps in existing knowledge,: Oral cancer, one of the top three common cancers in India is usually preceded by Oral potentially malignant disorders in nearly two thirds of the cases like Oral leukoplakia. OL has a high prevalence and malignant transformation rates(0.13% - 40.8%). There are no universal protocols for management in OL ranging from preventive, conservative, medical and surgical interventions. They all have limitations and high recurrence rates requiring regular follow up.\n\n(ii)Novelty: Removal of pathological lesions are believed to reduce the risk of malignant transformation in OL. Surgical methods are associated with morbidity and high recurrence rates. Non -invasive methods (like Photodynamic therapy) that can remove the abnormal lesions would be preferred as they are cheaper, convenient, safe with less morbidity and better patient acceptability. They also have the advantage of repeatability with minimum morbidity and damage to adjacent normal tissues. Non -invasive medical management involves topical application of retinoids which are associated with systemic toxicity, recurrence and development of resistance.\n\n(iii)Objectives,\n\nPrimary objective:\n\nTo compare the effect of 2.5% Toluidine blue mediated topical photodynamic therapy and topical calcipotriol (0.005%) on clinical response after completion of treatment at 4 weeks from baseline during management of Oral leukoplakia\n\nSecondary objectives:\n\nTo compare the effect of 2.5% Toluidine blue mediated topical photodynamic therapy with topical Calcipotriol (0.005%) on lesion size, lesion roughness\u002F whiteness, and oral health quality of life after completion of treatment at 4 weeks and 12 weeks from baseline during management of Oral leukoplakia To compare the effect of 2.5% Toluidine blue mediated topical photodynamic therapy with topical Calcipotriol (0.005%) on salivary molecular markers ( IL6, TNF-α, PCNA, Survivin and VEGF) after completion of treatment at 4 weeks from baseline To compare the adverse events, time to complete response and recurrence rates between the two groups\n\n(iv)Methods,: An open label randomized clinical trial where Group A (n=83) will receive 4 sessions of Toludine blue mediated photodynamic therapy (Fluence 15J\u002Fcm2); GroupB (n=83) will receive twice daily tropical application of Calcipotriol (0.005%) over a period of 4 weeks. The clinical response, lesion thickness\u002F whiteness, lesion size \u002Farea, OHIP-14 scores, adverse events and recurrence rates will be compared with baseline at 4 weeks and 12 weeks after completion of therapy. Sterile PVA ophthalmic sponges will be used to evaluate molecular markers ( IL6, TNF-α, PCNA, Survivin VEGF) from treatment site of lesion at baseline and 4 weeks after completion of treatment by ELISA. The data will be analyzed statistically using Intention to treat and as per protocol analysis at significance levels of p\\\u003C0.05.\n\n(v)Expected outcome.: The study will validate and verify the effectiveness of the TB mediated PDT protocol in the management of OL as compared to other non invasive method of topical Calcipotriol in terms of clinical response ( complete\u002F partial\u002F none), lesion thickness\u002F whiteness, lesion size and it's effect on oral health quality of life. Adverse events if any and recurrence rates or malignant transformation rates will also help in assessment of safety of the protocol. The molecular markers will help to monitor and determine prognosis of the lessons following treatment.",[28],"Oral Leukoplakia",[30,31,32,33,34,35,36],"Oral leukoplakia","photodynamic therapy","photosensitizers","calcipotriol","assessment","patient outcomes","biology molecular","NOT_YET_RECRUITING","2026-02-27",{"date":40,"type":41},"2026-03-06","ACTUAL",{"date":43,"type":22},"2026-04",{"date":45,"type":22},"2029-03",{"name":47,"class":48},"Dr. Shalini Gupta","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":49},"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,{"count":60,"type":22},315,[62],"NA","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.",[65],"Oral Submucous Fibrosis",[65,67,68,69,70,71,72,73],"trismus","Burning pain","diode laser","Photobiology","Electromyography","molecular biology","oral health","RECRUITING","2024-10-10",{"date":77,"type":41},"2024-10-15",{"date":79,"type":41},"2024-09-01",{"date":81,"type":22},"2027-12-31",{"name":47,"class":48},""]