| CTRI Number |
CTRI/2025/05/087250 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of exercise physiotherapy with or without LASER therapy in treating oral submucous fibrosis: A randomized study |
|
Scientific Title of Study
|
Clinical outcomes of exercise physiotherapy interventions with and without LASER therapy in conservative oral submucous fibrosis management: A randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dineshkumar Sorani |
| Designation |
In-charge Principal |
| Affiliation |
Government Physiotherapy College Jamnagar |
| Address |
Near Government Dental College Jamnagar
Department of Physiotherapy
Jamnagar
GUJARAT
361008
India |
| Phone |
9426786167 |
| Fax |
|
| Email |
soranidinesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dineshkumar Sorani |
| Designation |
In-charge Principal |
| Affiliation |
Government Physiotherapy College Jamnagar |
| Address |
Near Government Dental College Jamnagar
Department of Physiotherapy
Jamnagar
GUJARAT
361008
India |
| Phone |
9426786167 |
| Fax |
|
| Email |
soranidinesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dineshkumar Sorani |
| Designation |
In-charge Principal |
| Affiliation |
Government Physiotherapy College Jamnagar |
| Address |
Near Government Dental College Jamnagar
Department of Physiotherapy
Jamnagar
GUJARAT
361008
India |
| Phone |
9426786167 |
| Fax |
|
| Email |
soranidinesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| MULTIDISCIPLINARY RESEARCH UNIT,M P SHAH GOVERNMENT MEDICAL COLLEGE, JAMNAGAR, GUJARAT, INDIA |
|
|
Primary Sponsor
|
| Name |
MULTIDISCIPLINARY RESEARCH UNIT SHRI M P SHAH GOVERNMENT MEDICAL COLLEGE JAMNAGAR |
| Address |
SHRI M P SHAH GOVERNMENT MEDICAL COLLEGE JAMNAGAR, GUJARAT, INDIA |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR DINESHKUMAR SORANI |
Government Physiotherapy College Jamnagar |
Department of Physiotherapy, Government Physiotherapy College, Near Government Dental College Jamnagar Gujagat
Jamnagar
GUJARAT |
9426786167
soranidinesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE, M P SHAH GOVERNMENT MEDICAL COLLEGE GURU GOBINDSINGH HOSPITAL JAMNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
low level laser therapy plus conventional physiotherapy |
low level laser therapy for twice a week for four weeks.
conventional therapy daily for four weeks |
| Intervention |
Low Level Laser Therapy plus conventional physiotherapy exercises. |
twice a week for four weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
Patients with associated malignancies
Have undergone any surgical procedure involving face and jaws
Contraindications to laser therapy or inability to perform physiotherapy exercises |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mouth Opening
Pain Reduction |
Baseline
Post intervention at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |