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CTRI Number  CTRI/2021/10/037650 [Registered on: 28/10/2021] Trial Registered Prospectively
Last Modified On: 12/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Diagnostic
Dentistry 
Study Design  Single Arm Study 
Public Title of Study   A study to assess the masticatory muscle activity before and after treatment of patients who are diagnosed with oral submucous fibrosis [OSF] 
Scientific Title of Study   Electromyography analysis of the masseter muscle activity in the management of Oral Submucous Fibrosis 
Trial Acronym  Not assigned 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr P Poornachitra 
Designation  MDS post graduate student 
Affiliation  Saveetha Dental College and Hospital 
Address  Department of oral medicine, Diagnosis and Radiology, Saveetha Dental College and Hospital, 162, Poonamallee High Road, Velappanchavadi, Chennai

Thiruvallur
TAMIL NADU
600077
India 
Phone  9841530857  
Fax    
Email  poornachitra3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayanth Kumar Vadivel MDS  
Designation  Reader 
Affiliation  Saveetha Dental College and Hospital 
Address  Department of oral medicine, Diagnosis and Radiology, Saveetha Dental College and Hospital, 162, Poonamallee High Road, Velappanchavadi, Chennai

Thiruvallur
TAMIL NADU
600077
India 
Phone  8056135807  
Fax    
Email  doctorjayanth@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayanth Kumar Vadivel MDS  
Designation  Reader 
Affiliation  Saveetha Dental College and Hospital 
Address  Department of oral medicine, Diagnosis and Radiology, Saveetha Dental College and Hospital, 162, Poonamallee High Road, Velappanchavadi, Chennai

Thiruvallur
TAMIL NADU
600077
India 
Phone  08056135807  
Fax    
Email  doctorjayanth@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Dental College and Hospital  
 
Primary Sponsor  
Name  Saveetha Dental College and Hospital  
Address  Saveetha Institute of Medical and Technical Sciences Saveetha Dental College and Hospital Saveetha university 162, Poonamallee High Road, Velappanchavadi, Chennai 044 26801583 doctorjayanth@gmail.com 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrJayanth kumar vadivel  Saveetha Dental College and Hospital   Saveetha Dental College and Hospital 162, Poonamallee High Road, Velappanchavadi, Chennai 044 26801583 doctorjayanth@gmail.com
Thiruvallur
TAMIL NADU 		 08056135807

doctorjayanth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Scientific Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K135||Oral submucous fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intralesional corticosteroid injection  Oral submucous fibrosis treated with intralesional injection of dexamethasone 1.5 ml, hyaluronidase 1500 IU with 0.5 ml lignocaine HCL biweekly along with oral Lycopene 5000 mcg capsule once daily for 6 weeks 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Adult males or females with a diagnosis of Oral Submucous fibrosis with restricted mouth opening on clinical examination and without severe epithelial dysplasia on histopathology report. 
 
ExclusionCriteria 
Details  Adult males or females with a diagnosis of Oral Submucous fibrosis without restricted mouth opening on clinical examination, or with restricted mouth opening on clinical examination combined with severe epithelial dysplasia on histopathology report. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quantification of electrical activity of the masseter muscle   Force of muscle contraction measured in microvolts and onset of muscle activity measured in milliseconds 
 
Secondary Outcome  
Outcome  TimePoints 
Increased in mouth opening measured  Inter-incisal distance [between upper and lower incisor edge] measured in millimeters 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/11/2021 
Date of Study Completion (India) 20/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  doctorjayanth@gmail.com

  6. For how long will this data be available start date provided 26-12-2023 and end date provided 26-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

This study is an interventional single centre trial comparing the masseter muscle activity before and after treatment of oral submucous fibrosis patients using electromyography. The sampling is non-randomized convenient method where in the intervention group the patients diagnosed with oral submucous fibrosis are treated with intralesional injection of dexamethasone 1.5 ml, hyaluronidase 1500 IU with 0.5 ml lignocaine HCL biweekly along with oral Lycopene 5000mcg capsule once daily for 6 weeks. After 12 injections, the electromyography readings are repeated. There are two comparisons done in this study. The first comparison is the pre and post treatment. The second comparison is between the disease and the comparator group. This comparator group will have age and gender matched 20 OSMF free comparators.

 
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