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CTRI Number  CTRI/2024/06/068807 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 24/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Comparing salivary flow rate in Oral Submucous Fibrosis Patients before and after treatment 
Scientific Title of Study   Comparative evaluation of salivary flow rate in Oral Submucous Fibrosis patients before and after Transcutaneous Electric Nerve Stimulation 
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 Tanaya Teredesai 
Designation  MDS 1st year Post graduate student 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  001 Department of Oral Medicine and Radiology, Sharad Pawar Dental College, Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  9309934726  
Fax    
Email  tanayateredesai743@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suwarna Dangore  
Designation  Professor and Head, Department of Oral Medicine and Radiology 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  001 Department of Oral Medicine and Radiology, Sharad Pawar Dental College, Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  9923024036  
Fax    
Email  dangore_suwarna@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suwarna Dangore  
Designation  Professor and Head, Department of Oral Medicine and Radiology 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  001 Department of Oral Medicine and Radiology, Sharad Pawar Dental College, Sawangi Meghe


MAHARASHTRA
442001
India 
Phone  9923024036  
Fax    
Email  dangore_suwarna@rediffmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Sawangi Wardha India 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research  
Address  Sawangi Meghe Wardha India 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tanaya Teredesai  Sharad Pawar Dental College  001 Ground floor department of Oral Medicine and Radiology SPDC building Sawangi 442001
Wardha
MAHARASHTRA 		 9309934726

tanayateredesai743@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Datta Meghe Institute of Higher Education and Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K117||Disturbances of salivary secretion,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Transcutaneous Electric Stimulation   Patients between the age group of the 18– 45 years and suffering from Oral Submucous Fibrosis with reduced salivation will be included. The Modified Schirmer test (MST) will be used to evaluate salivary flow rate before and after TENS therapy. Frequency is one time at the time of patient first visit  
Comparator Agent  Transcutaneous Electric Stimulation  Patients between the age group of the 18– 45 years and suffering from Oral Submucous Fibrosis with reduced salivation will be included. The Modified Schirmer test (MST) will be used to evaluate salivary flow rate before and after TENS therapy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients between age group of 18-45 years will be included in the study. Individuals with clinically established stages of OSMF with burning sensation, limited mouth opening, palpable fibrous bands. Patients giving history of decreased salivation for a duration of more than 6 months. Clinical examination revealed hyposalivation due to habit induced OSMF will be included in the study group. 
 
ExclusionCriteria 
Details  The study excludes patients undergoing treatment for Oral Submucous Fibrosis, those with any salivary gland disorder, whether they are currently on medication for it or not. Additionally, individuals with a history of stress, systemic conditions or diseases likely to decrease salivation, radiation therapy, mental illness, oral mucosal lesions, and denture wear are excluded. Moreover, participants using medications that could affect salivary parameters, such as diuretics, anticholinergics, antihistamines, antihypertensives, and psychotropic substances, are not considered. Those with prolonged habits of smoking and alcohol consumption are also excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Significant increase in salivary flow rate after Transcutaneous Electric Nerve Stimulation in Oral Submucous Fibrosis patients  Assessment will be done at 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   NA 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 3/ Phase 4 
Date of First Enrollment (India)   09/07/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Introduction- A persistent, precancerous, and frequently debilitating condition - oral submucous fibrosis is characterized by a slowly progressing fibrosis of the oropharynx and oral cavity. Reduction  in salivary flow is one of the common symptom experienced by the sufferer. Using electric current to stimulate nerves, Transcutaneous Electric Nerve Stimulation (TENS)  for improving salivation serves as a simple, affordable, and non-invasive method. TENS can decrease the discomfort  due to long-lasting hyposalivation. 
Need of the study- Although  the effectiveness of TENS on salivary flow rate is studied in number of conditions,  the evidence/ studies describing the effect of TENS on salivary flow rate  in oral sub mucus fibrosis patients is not found. This contemplated the intention of the present study. 
Aim- To evaluate and compare salivary flow rate in oral submucous fibrosis patients before and after transcutaneous electric nerve stimulation. 
Materials and method- This protocol for prospective research study will be undertaken at Sharad Pawar Dental College, Department of Oral Medicine and Radiology in the state of Maharashtra, in India, from February 2024 to January 2025. Patients between the age group of the 18– 45 years and suffering from Oral Submucous Fibrosis and evaluated on basis of Inventory of Xerostomia (XI) questionnaire to have reduced salivation will be included. The Modified Schirmer test (MST) will be used to evaluate salivary flow rate  before and after TENS therapy.  All the findings will be recorded in a tabular format and are subjected to appropriate statistical tests to evaluate the statistical significance regarding the improvement in salivary flow rate.
 
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