| CTRI Number |
CTRI/2025/07/090239 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Checking hearing problem in thickened skin of mouth |
|
Scientific Title of Study
|
Evaluating hearing impairment in different histopathological stages of OSMF: An Audiometric Analysis |
| 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 Shweta Thakkar |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
Department of Oral Medicine and Radiology Government Dental College and Hospital Pathikashram main road Navagam Jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9909220416 |
| Fax |
|
| Email |
shwetathakkar86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reeta Jha |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
Department of Oral Medicine and Radiology Government Dental College and Hospital Pathikashram main road Navagam Jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9429272080 |
| Fax |
|
| Email |
reetajha01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reeta Jha |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
Department of Oral Medicine and Radiology Government Dental College and Hospital Pathikashram main road Navagam Jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9429272080 |
| Fax |
|
| Email |
reetajha01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental college and hospital, Jamnagar, 361008 |
|
|
Primary Sponsor
|
| Name |
Dr Shweta Thakkar |
| Address |
Department of Oral Medicine and Radiology Government Dental College and Hospital Pathikashram main road Navagam Jamnagar Gujarat 361008 |
| 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 Shweta Thakkar |
Government Dental College and Hospital Jamnagar |
Department no. 2 Department of Oral Medicine and Radiology Government Dental College and Hospital Post Graduate Clinic Pathikashram main road Navagam Jamnagar Gujarat
Jamnagar
GUJARAT |
9909220416
shwetathakkar86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, M.P Shah Medical College and Guru Gobind Singh Hospital, Jamnagar |
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 |
Control Population |
control population without any premalignant disorders or any deleteriouy habits with associated normal mouth opening |
| Intervention |
Grade 1 OSMF Case group with mouth opening greater than 35 mm |
Biopsy will be done from right or left buccal mucosa followed by audiometry and tympanometry |
| Intervention |
Grade IV OSMF Case group with mouth opening lesser than 15 mm |
Biopsy will be done from right or left buccal mucosa followed by audiometry and tympanometry |
| Intervention |
OSMF Grade II patients with mouth opening between 25-35mm |
Biopsy will be done from right or left buccal mucosa followed by audiometry and tympanometry |
| Intervention |
OSMF grade III patients with mouth opening between 15-25mm |
Biopsy will be done from right or left buccal mucosa followed by audiometry and tympanometry |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having following signs and symptoms
burning sensation and difficulty in eating hot and spicy food
reduced mouth opening
blanched or opaque appearance of mucosa |
|
| ExclusionCriteria |
| Details |
subjects not willing to participate in study
patients on chemotherapy or radiotherapy or undergoing any surgery for OSMF
any systemic and genetic disease
pregnant women
patients with genetic or prelingual deaf or acquired hearing loss
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect on hearing efficiency according to clinical grade of OSMF |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlation between effect on hearing efficiency and histopathological grade of OSMF |
7 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
07/07/2025 |
| 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="2"
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
|
The purpose of this study is to evaluate the prevalence and nature of hearing impairment in patients diagnosed with Oral Submucous Fibrosis (OSMF) and to correlate these findings with the histopathological grading of the disease To assess the prevalence of hearing impairment in patients diagnosed with Oral Submucous Fibrosis (OSMF) To classify and correlate the degree of hearing loss with the histopathological grades of OSMF To investigate the underlying mechanisms contributing to auditory dysfunction in OSMF patients To highlight the importance of incorporating routine audiometric evaluations in the clinical management of OSMF To provide data-driven recommendations for a multidisciplinary approach to the diagnosis and treatment of OSMF-related complications |