Effect of exercise physiotherapy with or without LASER therapy in treating oral submucous fibrosis: A randomized study
- Conditions
- Oral submucous fibrosis,
- Registration Number
- CTRI/2025/05/087250
- Lead Sponsor
- MULTIDISCIPLINARY RESEARCH UNIT SHRI M P SHAH GOVERNMENT MEDICAL COLLEGE JAMNAGAR
- Brief Summary
This randomized controlled trial aims to evaluate the clinical outcomes of exercise physiotherapy interventions with and without LASER therapy in the conservative management of oral submucous fibrosis Participants diagnosed with OSMF will be randomly assigned to either the Exercise Physiotherapy Only group or the Exercise Physiotherapy with LASER Therapy group. The intervention will be conducted over a predefined period, with assessments at baseline and post-intervention. Primary outcomes include mouth opening and pain reduction. Data will be analyzed using paired t-tests or Wilcoxon signed-rank tests for within-group comparisons and independent t-tests or Mann-Whitney U tests for between-group comparisons, based on data normality. Effect sizes will be estimated to determine clinical significance. A p-value less than 0.05 will be considered statistically significant. The study aims to provide evidence on the effectiveness of LASER therapy as an adjunct to exercise physiotherapy in improving mouth opening and reducing pain in OSMF patients. Findings from this study will contribute to evidence-based recommendations for non-surgical management strategies in OSMF.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 33
Patients diagnosed with OSMF based on clinical and histopathological findings Interincisal mouth opening less than 35mm Willingness to participate and provide informed consent Have not undergone any surgical intervention before Have quit the habit for more than 6 months.
Patients with associated malignancies Have undergone any surgical procedure involving face and jaws Contraindications to laser therapy or inability to perform physiotherapy exercises.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain Reduction Baseline | Post intervention at 4 weeks Mouth Opening Baseline | Post intervention at 4 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Government Physiotherapy College Jamnagar
🇮🇳Jamnagar, GUJARAT, India
Government Physiotherapy College Jamnagar🇮🇳Jamnagar, GUJARAT, IndiaDR DINESHKUMAR SORANIPrincipal investigator9426786167soranidinesh@gmail.com