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CTRI Number  CTRI/2025/03/081918 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 12/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to test the Effectiveness of Chewy Tubes R alongwith intralesional steroids in improving the Mouth Opening in Patients Suffering from Oral Submucous Fibrosis  
Scientific Title of Study   Effectiveness of Chewy Tubes R in enhancing Mouth Opening in Patients Suffering from Oral Submucous Fibrosis; A Randomized Controlled Trial  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
230410001  ClinicalTrials.gov 
24088  NIL 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Jasmine Jophy 
Designation  MDS second year, student, Oral Medicine and Radiology 
Affiliation  Manipal College of Dental Sciences,Mangalore. 
Address  MANIPAL COLLEGE OF DENTAL SCIENCES , HAMPANKATTA , LIGHT HOUSE HILL ROAD ,MANGALORE.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8921873248  
Fax    
Email  jasminejophy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RAVIKIRAN ONGOLE 
Designation  Professor ,Department of Oral Medicine and Radiology 
Affiliation  Manipal College of Dental Sciences,Mangalore. 
Address  MANIPAL COLLEGE OF DENTAL SCIENCES, HAMPANKATTA, LIGHT HOUE HILL ROAD ,MANGALORE.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8921873248  
Fax    
Email  ravikiran.ongole@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr. Jasmine Jophy 
Designation  MDS second year, student.ORAL MEDICINE AND RADIOLOGY 
Affiliation  Manipal College of Dental Sciences,Mangalore. 
Address  MANIPAL COLLEGE OF DENTAL SCIENCES LIGHTHOUSE HILL ROAD HAMPANKATTA 575001

Dakshina Kannada
KARNATAKA
575001
India 
Phone  8921873248  
Fax    
Email  jasminejophy@gmail.com  
 
Source of Monetary or Material Support  
Speech Pathology Associates .LLC, makers of Chewy Tube R , South Portland USA. 
 
Primary Sponsor  
Name  Speech Pathology Associates LLC 
Address  Speech Pathology,LLC,Makers of Chewy Tube R , South Portland USA. 
Type of Sponsor  Private hospital/clinic 
 
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 
DR JASMINE JOPHY  MANIPAL COLLEGE OF DENTALSCIENCES  KMC LIGHTHOUSE HILL ROAD HAMPANKATTA 575001
Dakshina Kannada
KARNATAKA 		 08921873248

jasminejophy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Betamethasone   Betamethasone 4mg per ml 1 vial O.D. 4mg for 1 month.  
Intervention  chewy tubes   Chewy Tubes are to be used five times a day for a duration of two minutes for one week. 5 times a day for one week.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients suffering from stages II and III OSMF will be included (as per Khanna and Andrade Classification). 
 
ExclusionCriteria 
Details  Patients suffering from Stage I and Stage IV OSMF with mouth opening of less than 18 mm will not be included.
2) Patients who are not willing to participate in the study.
3) Patients allergic to Chewy Tubes®.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the interincisal distance in patients undergoing intralesional steroid injections versus those undergoing a combination of intralesional steroid injections and chewy tubes at the end of one month of treatment.  once a week for four weeks 
 
Secondary Outcome  
Outcome  TimePoints 
2. To evaluate burning sensation in both the groups  once a week for four weeks 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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   Phase 2 
Date of First Enrollment (India)   18/03/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jasminejophy@gmail.com].

  6. For how long will this data be available start date provided 20-12-2024 and end date provided 20-12-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 This study assesses the effectiveness of Chewy Tube alongwith intralesional steroid injections in 38  patients with OSMF. The study consists  of one month follow up and the patients are re called weekly once for four weeks to assess the mouth opening using scale (mm) and burning sensation using visual analog scale. (VAS) The Chewy tubes are to be chewed for 2minutes, five times a day. Patient informed consent forms will be collected before the initiation of the study. 
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