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Hearing impairment in patients with OSMF

Completed
Conditions
suffering with oral submucous fibrosis
Not suffering with oral submucous fibrosis
Registration Number
CTRI/2017/10/010161
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
200
Inclusion Criteria
  • 1.Subjects ranging between the age group of 13 to 35 yrs.
  • Systemically healthy subjects.
  • Patients having OSMF.
Exclusion Criteria
  • 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.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Trace elements Copper Iron and Zinc12 months
Secondary Outcome Measures
NameTimeMethod
Audiometry anaylsis12 months

Trial Locations

Locations (1)

NKPS Institute of Medical Sciences Digdoh Hills Hingna Road

🇮🇳

Nagpur, MAHARASHTRA, India

NKPS Institute of Medical Sciences Digdoh Hills Hingna Road
🇮🇳Nagpur, MAHARASHTRA, India
Dr Surekha Rathod
Principal investigator
9011071477
drsurekhar@gmail.com

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