Using laser therapy to improve mouth opening in patients with Oral Submucous Fibrosis
Official title: 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
Run by All India Institute of Medical Sciences · NCT06639009 · Data updated 2026-11-12
This study is testing whether laser therapy can help people with Oral Submucous Fibrosis open their mouths more easily and improve their overall oral health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 315 (estimated) |
| Sponsor | All India Institute of Medical Sciences Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | November 30, 2025 |
| Study ends | December 31, 2027 |
| Registry record updated | October 15, 2024 |
| Trial ID | NCT06639009 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with symptomatic bilateral moderate Oral Submucous Fibrosis who have not undergone any interventions for at least three months prior to the study.
✕Probably not a fit
Patients with other oral potentially malignant disorders or those with a history of malignancies or certain systemic diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of 940nm laser photobiomodulation therapy in enhancing mouth opening in patients diagnosed with moderate Oral Submucous Fibrosis, a precancerous condition. The study is designed as a patient and outcome assessor blinded, multiple-arm, randomized placebo-controlled trial. Participants will be divided into three groups to receive different forms of treatment, including laser therapy and conventional management. The trial will also evaluate the impact of the therapy on oral burning sensation, cheek flexibility, muscle activity, inflammatory markers, and overall oral health quality of life over a period of three months.
Why it matters
Potential benefit: If successful, this therapy could significantly improve mouth opening and quality of life for patients suffering from Oral Submucous Fibrosis.
How similar studies have gone: While the specific application of laser therapy in this context may be novel, similar studies have shown promising results in using photobiomodulation for various conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 \-
Where it's running
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All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India Recruiting
Study contacts
- Principal investigator: Shalini Gupta, MDS, FDSRCS(Edin) — All India Institute of Medical Sciences
- Study coordinator: Shalini Gupta, MDS, FDSRCS(Erin)
- Email: shalinigupta@hotmail.com
- Phone: 919971904592
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.