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A prospective study to assess the hearing efficiency following surgical intervention of oral submucous fibrosis by using tympanometry and audiometry.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085358
Enrollment
10
Registered
2025-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: 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 na

Sponsors

DR BHEKE PRACHI DEEPAK
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients undergoing surgery for oral submucous fibrosis

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
IMPROVEMENT IN HEARING EFFICIENCY FOLLOWING SURGICAL INTERVENTION OF ORAL SUBMUCOUS FIBROSIS BY USING TYMPANOMETRY AND AUDIOMETRYTimepoint: ASSESSMENT WILL BE DONE PREOPERATIVELY, 1 MONTH POST SURGERY AND 3 MONTHS POST SURGERY.

Secondary

MeasureTime frame
audiometry scaleTimepoint: preoperative, 1 month post surgery, 3 months post surgery;tympanometry scaleTimepoint: preoperative, 1 month post surgery, 3 months post surgery

Countries

India

Contacts

Public ContactDR BHEKE PRACHI DEEPAK

BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANAGERE

harinint80@gmail.com9449834326

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026