跳至主要内容
临床试验/CTRI/2025/04/085358
CTRI/2025/04/085358尚未招募不适用

Assessment of hearing efficiency following surgical intervention of oral submucous fibrosis by using tympanometry and audiometry- a prospective study.

DR BHEKE PRACHI DEEPAK1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年4月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
IMPROVEMENT IN HEARING EFFICIENCY FOLLOWING SURGICAL INTERVENTION OF ORAL SUBMUCOUS FIBROSIS BY USING TYMPANOMETRY AND AUDIOMETRY

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • patients undergoing surgery for oral submucous fibrosis.

排除标准

  • 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.
  • Patients with any other premalignant oral lesions and any other etiology of trismus, e.g. Temporomandibular joint problems, pericoronitis, scleroderma, etc.
  • Patients who refuse to undergo ear testing or fail to come for follow up.
  • Patients who do not comply with postoperative instructions.
  • Patients with OSMF showing mild dysplastic changes.

结局指标

主要结局

IMPROVEMENT IN HEARING EFFICIENCY FOLLOWING SURGICAL INTERVENTION OF ORAL SUBMUCOUS FIBROSIS BY USING TYMPANOMETRY AND AUDIOMETRY

时间窗: ASSESSMENT WILL BE DONE PREOPERATIVELY, 1 MONTH POST SURGERY AND 3 MONTHS POST SURGERY.

次要结局

  • audiometry scale(preoperative, 1 month post surgery, 3 months post surgery)
  • tympanometry scale(preoperative, 1 month post surgery, 3 months post surgery)

研究者

发起方
DR BHEKE PRACHI DEEPAK
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR Bheke Prachi Deepak

BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANAGERE

研究点 (1)

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