| 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
|
|
|
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
|
|
|
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
|
|
|
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 |