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CTRI Number  CTRI/2025/10/096691 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 26/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Ultrasound therapy and Injection Treatment in managing oral submucous fibrosis 
Scientific Title of Study   A comparative study of efficacy of Therapeutic Ultrasound therapy and Intralesional Injection in patients with oral submucous fibrosis - a clinical trial study 
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 Nikita Waghmare 
Designation  Post graduate student 
Affiliation  SMBT dental college and hospital ghulewadi Sangamner 
Address  G-01 Department of Oral Medicine and Radiology SMBT dental college and hospital Ghulewadi Sangamner

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  8554976022  
Fax    
Email  iamnikitawaghmare@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shital Nikam  
Designation  Reader and PG Guide 
Affiliation  SMBT dental college and hospital ghulewadi Sangamner 
Address  G-01 Department Of Oral Medicine and Radiology SMBT dental college and hospital ghulewadi Sangamner

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9028813698  
Fax    
Email  drshital1987@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nikita Waghmare 
Designation  Post graduate student 
Affiliation  SMBT dental college and hospital ghulewadi Sangamner 
Address  G-01 Department of Oral Medicine and Radiology SMBT dental college and hospital ghulewadi Sangamner

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  8554976022  
Fax    
Email  iamnikitawaghmare@gmail.com  
 
Source of Monetary or Material Support  
SMBT dental college and hospital ghulewadi Sangamner, Maharashtra, India 422608 
 
Primary Sponsor  
Name  Dr Nikita Waghmare 
Address  Department of Oral Medicine and Radiology SMBT dental college and hospital ghulewadiSangamner,Maharashtra,India,422608 
Type of Sponsor  Other [Self] 
 
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 Nikita Waghmare  SMBT dental college and hospital, sangamner  G-01 Department of Oral Medicine and Radiology SMBT dental college and hospital, ghulewadi, Sangamner,Ahmadnagar,Maharashtra 422608
Ahmadnagar
MAHARASHTRA 		 8554976022

iamnikitawaghmare@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Committee On Ethics,SMBT Dental College Sangamner  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 
Comparator Agent  efficacy of therapeutic ultrasound therapy and intralesional injection in patients with oral submucous fibrosis.  After meeting the inclusion and exclusion criteria, the patients who were chosen for the study were divided into groups A and B.Fifteen OSMF patients in Group A received injections of two millilitres of dexamethasone (4 mg/ml) and 1500 IU of hyaluronidase. Group B comprises 15 OSMF patients who received physical activity and therapeutic ultrasound treatment. Patients will have intralesional injections and ultrasound therapy application every two weeks for a total of four weeks.  
Intervention  This study is to assess the effects of intralesional injection of dexamethasone, hyaluronidase and adjuvant therapeutic ultrasonography with physical therapy and in the treatment of persons with oral submucous fibrosis.  The intralesional injections have a number of drawbacks, including the need for multiple injections, which can be uncomfortable for the patient and cause pain and temporary swelling at the injection site, the possibility of bleeding or hematoma formation, and the fact that they are not always effective. In light of these drawbacks, alternative treatments for OSMF are being investigated. Ultrasonic treatment: ultrasonic waves heat tissue more deeply than moist heat does, increasing blood flow, removing pain, and healing tissue.1 The impact of ultrasound as a supplement to traditional modalities has been studied in OSMF. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  a. All age group patient.
b. Clinically diagnosed with OSMF
 
 
ExclusionCriteria 
Details  a. The existence of any additional illnesses, such as tetany or systemic sclerosis
b. The history of radiation therapy
c. The history of OSMF medicinal or surgical treatment
d. The existence of systemic disease

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The study aims to determine which treatment therapy, along with regular mouth opening exercises and a cessation of the betel quid chewing habit, will proven to be essential for managing OSMF cases in both the early and severe stages of advancement.
In individuals with OSMF, the therapeutic ultrasound will show significant impact on all the parameters including cheek flexibility and mouth opening and it will be works well as an adjuvant in conjunction with combination therapy.
 		 at baseline 4 weeks and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 4 
Date of First Enrollment (India)   09/11/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    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 [iamnikitawaghmare@gmail.com].

  6. For how long will this data be available start date provided 17-10-2025 and end date provided 17-10-2027?
    Response (Others) - 

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

The goal of this study is to assess the effects of intralesional injection of dexamethasone, hyaluronidase and adjuvant therapeutic ultrasonography with physical therapy and in the treatment of persons with oral submucous fibrosis. To assess the effectiveness of intralesional injection and ultrasound therapy in patients with oral submucous fibrosis. Thirty patients selected who met the inclusion criteria with all age group and clinically diagnosed with oral submucous fibrosis were included in the study. Exclusions from the study were patients having a history of radiation therapy, OSMF medication or surgery, systemic sclerosis, tetany, or other systemic diseases. Prior to the study’s commencement, institutional ethical committee approval was acquired. Every participant in this study provided written informed permission. After meeting the inclusion and exclusion criteria, the patients who were chosen for the study were divided into groups A and B based on the sequence created by the software. Fifteen OSMF patients in Group A received injections  of dexamethasone (4 mg/ml) and 1500 IU of hyaluronidase. Group B comprises 15 OSMF patients who received physical activity and therapeutic ultrasound treatment. Patients will have intralesional injections and ultrasound therapy application every two weeks for a total of four weeks. Areas for submucosal local injection include the buccal mucosa, pterygomandibular raphae, outer soft palate, and any circumoral bands. Dexamethasone (4 mg/ml) and 1500 IU of hyaluronidase injection. All of the patients received treatment using the same calibrated ultrasound equipment throughout the research [Figure  Regarding the ultrasound therapy procedure, ultrasound at a continuous 1:1 duty cycle intensity of 1.5 to 1.8 W/cm2 ,3 MHz for 5–6 minutes while moving a sound head back and forth in the template at a pace of around 4 cm/s to each side over the fibrosis area.


 
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