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CTRI Number  CTRI/2025/04/085358 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 18/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   A prospective study to assess the hearing efficiency following surgical intervention of oral submucous fibrosis by using tympanometry and audiometry. 
Scientific Title of Study   Assessment of hearing efficiency following surgical intervention of oral submucous fibrosis by using tympanometry and audiometry- a prospective 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 Bheke Prachi Deepak 
Designation  POST GRADUATE STUDENT, 
Affiliation  BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANAGERE 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE - KARNATAKA.

Davanagere
KARNATAKA
577004
India 
Phone  7756054354  
Fax    
Email  prachibheke@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR GEETHA N T 
Designation  PROFESSOR 
Affiliation  BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANAGERE 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE - KARNATAKA.

Davanagere
KARNATAKA
577004
India 
Phone  9449834326  
Fax    
Email  harinint80@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR BHEKE PRACHI DEEPAK 
Designation  POST GRADUATE STUDENT 
Affiliation  BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANAGERE 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE - KARNATAKA.

Davanagere
KARNATAKA
577004
India 
Phone  7756054354  
Fax    
Email  prachibheke@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  DR BHEKE PRACHI DEEPAK 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE, KARNATAKA, INDIA - 577004 
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 PRACHI BHEKE  BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE - 577004 KARNATAKA
Davanagere
KARNATAKA 
7756054354

prachibheke@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE, KARNATAKA  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  nil  nil 
Intervention  The intervention will be fibrotomy and reconstruction of oral mucosa followed by reconstruction using various approaches.  The surgery will be performed under general anesthesia with nasoendotracheal intubation. The surgery will be performed to release the fibrous bands in bilateral buccal mucosa followed by reconstruction using nasolabial flap/ buccal fat pad or collagen with silicone membrane. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  patients undergoing surgery for oral submucous fibrosis 
 
ExclusionCriteria 
Details  1. Patients with previous ear surgery, hearing aid, middle ear infections, trauma to ear, nasopharyngeal mass, patient working in noisy area, cleft lip and palate, auto sclerosis, etc.
2. Patients with any other premalignant oral lesions and any other etiology of trismus, e.g. Temporomandibular joint problems, pericoronitis, scleroderma, etc.
3. Patients who refuse to undergo ear testing or fail to come for follow up.
4. Patients who do not comply with postoperative instructions.
5. Patients with OSMF showing mild dysplastic changes.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
IMPROVEMENT IN HEARING EFFICIENCY FOLLOWING SURGICAL INTERVENTION OF ORAL SUBMUCOUS FIBROSIS BY USING TYMPANOMETRY AND AUDIOMETRY  ASSESSMENT WILL BE DONE PREOPERATIVELY, 1 MONTH POST SURGERY AND 3 MONTHS POST SURGERY. 
 
Secondary Outcome  
Outcome  TimePoints 
audiometry scale  preoperative, 1 month post surgery, 3 months post surgery 
tympanometry scale  preoperative, 1 month post surgery, 3 months post surgery 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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   N/A 
Date of First Enrollment (India)   30/04/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

      Oral Submucous Fibrosis (OSMF) is a chronic insidious disease, affecting any part of the oral cavity and sometimes the pharynx. Although occasionally preceded by and/or associated with vesicle formation, it is always associated with a juxta-epithelial inflammatory reaction followed by fibroelastic changes of the lamina propria, with epithelial atrophy leading to stiffness of the oral mucosa and causing trismus and inability to eat. Symptoms of this disease include burning sensation of the oral mucosa, ulceration and pain, reduced movement and depapillation of tongue, blanching and leathery texture of oral mucosa, loss of pigmentation of oral mucosa, and progressive reduction of mouth opening. Advanced cases show signs of loss of hearing due to blockage of Eustachian tube (ET) and difficulty in swallowing because of esophageal fibrosis.1

        Amongst structures communicating with the oral cavity the ET connects the middle ear cavity with the nasopharynx. Normal opening of the ET equalizes atmospheric pressure in the middle ear; closing of the ET protects the middle ear from unwanted pressure fluctuations and loud sounds. Abnormal or impaired ET functions (i.e., impaired opening or closing) may cause pathological changes in the middle ear. This in turn can lead to hearing disabilities. In OSMF, there can be failure of ET to effectively regulate air pressure. As ET function worsens, air pressure of middle ear falls and ear sounds are perceived as muffled and may cause impaired hearing. However there is a paucity of information related to the involvement by fibrosis of areas adjoining the oral cavity e.g. Ear, Oro-pharynx, and Pharynx.2

          Several stu­dies have clinically evaluated the eustachian tube function by audiometry and tympanometry and have found its significant impairment in OSMF patients as compared to healthy controls. These studies substantiate both clinically and histologically that eustachian tube function and hearing ability is impaired in OSMF.3

          Most of the  studies conducted so far include patients suffering from OSMF – Khanna and Andrade Grade IV only.  Also, limited number of studies appear to have compared the changes of ET functioning following surgical intervention of OSMF with that of pre surgical ET functioning. In this study we are trying to find out, the prevalence of ET dysfunction in different grades of OSMF patients. So, in our study we are trying to detect whether the surgical release of fibrous bands is of any help to improve hearing ability in such patients.4

 
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