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CTRI Number  CTRI/2017/10/010161 [Registered on: 23/10/2017] Trial Registered Retrospectively
Last Modified On: 28/01/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Hearing impairment in patients with OSMF 
Scientific Title of Study   Evaluation & comparison of hearing impairment in relation to Eustachian tube dysfunction and levels of trace elements in serum of patients with Oral Submucous Fibrosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Surekha Rathod 
Designation  Professor 
Affiliation  Department of Periodotntics and Implantology, VSPM Dental College and Research Centre, Nagpur 
Address  VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur Maharashtra India

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071477  
Fax    
Email  drsurekhar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Surekha Rathod 
Designation  Professor 
Affiliation  Department of Periodotntics and Implantology, VSPM Dental College and Research Centre, Nagpur 
Address  VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur Maharashtra India

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071477  
Fax    
Email  drsurekhar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Surekha Rathod 
Designation  Professor 
Affiliation  Department of Periodotntics and Implantology, VSPM Dental College and Research Centre, Nagpur 
Address  VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur Maharashtra India

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071477  
Fax    
Email  drsurekhar@gmail.com  
 
Source of Monetary or Material Support  
NKP SIMS, Nagpur 
VSPM Dental College and Research Centre, Nagpur  
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [No sponsor] 
 
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 Surekha Rathod  NKPS Institute of Medical Sciences Digdoh Hills Hingna Road  Department of ENT and Department of Biochemistry
Nagpur
MAHARASHTRA 		 9011071477

drsurekhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NKPSIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not suffering with oral submucous fibrosis 
Patients  suffering with oral submucous fibrosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1.Subjects ranging between the age group of 13 to 35 yrs.
2. Systemically healthy subjects.
3. Patients having OSMF
 
 
ExclusionCriteria 
Details  1. Patients with more than one type of lesion.
2. Patients with pathology of the middle ear, tympanic membrane perforation, cholesteotoma.
3. Other condition causing restrictive in mouth opening.
4. Patients with H/O drug intake containing iron, copper,& zinc.
5. Pregnant women & patients on oral contraceptives.
6. Patients who has undergone any treatment for OSMF.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Trace elements Copper Iron and Zinc  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Audiometry anaylsis  12 months 
 
Target Sample Size
Modification(s)  		 Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 01/01/2017 
Date of Study Completion (India) 31/05/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not yet published 
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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 28-11-2020 and end date provided 28-02-2021?
    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 was a Randomized, parallel group trial comparing the evaluation of hearing impairment in relation to Eustachian tube dysfunction and levels of trace elements in serum of patients with Oral Submucous Fibrosis. The primary outcome measures was the presence of trace elements namely Zn, Cu and  Fe in the serum and hearing impairment in patients suffering from OSMF.

Methods and materials: 200 patients were equally divided into two groups where group I comprised of patients without OSMF and group II with OSMF. A pure tone audiometry was used  performed to measure degree of hearing impairment while estimation of trace elements Cu, Zn and Fe was done by atomic absorption spectrophotometry. And following results were obtained.

Results: Normal hearing in 58% of the individuals and conductive hearing loss in 42% of the individuals in Group II. Group I individuals had normal hearing. The level of Cu was found increased in group II individuals while the levels of Zn and Fe was reduced. The mean level of serum Cu increased in Group II with hearing loss while the levels of Zn and Fe reduced.

Conclusion: The serum levels of trace elements and the conductive hearing loss with respect to OSMF are crucial for disease diagnosis. The levels of Cu are present in high concentration and the level of Zn and Fe is decreased in OSMF and also in hearing impairment individual.

 
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