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Effect of Laser Photobiomodulation in Improving Mouth Opening in Oral Submucous Fibrosis

RecruitingNAAges 18 Years - 99 YearsAllDr. Shalini Gupta
NCT06639009 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This a patient and outcome assessor blinded, multiple arm, randomized placebo controlled clinical trial. The 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. Adult 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 The three groups are as follows: Group A: Photobiomodulation therapy given intraorally on bilateral buccal mucosa and extraorally (sham) with

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📋 Eligibility rules (as published)
Inclusion Criteria: Subjects 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. Subjects willing to participate in the study \- Exclusion Criteria: Subjects with any other Oral potentially malignant disorders ( Leukoplakia/ Oral lichen planus etc ) other than OSMF. Subjects with OSMF with dysplasia in previous biopsy, suspicious lesion that requires biopsy for histopathological examination Subjects with any current / past history of any malignancies Subjects with any developmental disorders, cranio-maxillomandibular bony pathologies/ trauma, current odontogenic / 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 \-
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What it tests

  • 940nm diode laser photobiomodulation
  • Conventional non -Invasive management in Oral Submucous fibrosis
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Where

1 site
All India Institute of Medical Sciences
New Delhi, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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