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Comparison of efficacy Laser and Injection therapy for mouth opening treatment of Oral Submucous fibrosis Patients

Comparing the efficacy of Low Level Laser Therapy with & without Intralesional injection in Oral submucous fibrosis patients -A Randomized Controlled Clinical trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113322
Enrollment
24
Registered
2026-07-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Low level laser therapy with Intralesional Injection: Low level laser therapy after Intralesional Injection of Dexamethasone mixed with Injection Hyaluronidase twice a week for 4 weeks.

Sponsors

Dr Jitisha Maheshbhai Vania
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed case of OSMF Stage 2 or Stage 3 with mouth opening ranging from 15 35 mm as per More CB et al (2011) 2. Participants with no known allergies to the materials used in the treatment

Exclusion criteria

Exclusion criteria: 1.Systemic or infectious diseases such as HIV, hepatitis, diabetes, coagulopathies, blood disorders, Parkinson s disease, heart disease, pregnant or lactating women. 2. Participants having OSMF along with oropharyngeal or any other malignancy will be excluded from the study. 3.Participants who had undergone for past OSMF treatment. 4.Those unwilling to participate as well as the patient continuing of deleterious habits, shall be also grounds for exclusion.

Design outcomes

Primary

MeasureTime frame
Reduction of burning sensation and improvement in mouth opening Timepoint: At baseline , 3 months , 6 months

Secondary

MeasureTime frame
cheek flexibility & tongue protrusionTimepoint: At baseline , 3 months , 6 months

Countries

India

Contacts

Public ContactDR Pranay Patel

College of Dental Science and Hospital Amargadh Bhavnagar Gujarat

pranay.kms@gmail.com8238435882

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026