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Assessment of the Influence of the Prosthesis Diameter on Improvement of the Tinnitus after Stapedotomy

Assessment of the Influence of the Teflon Piston Prosthesis Diameter on Improvement of the Tinnitus after Stapedotomy in Patients with Otosclerosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180113038346N1
Enrollment
40
Registered
2018-03-04
Start date
2015-08-23
Completion date
Unknown
Last updated
2018-03-26

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

Conditions

Otosclerosis. Diseases of middle ear and mastoid

Interventions

Intervention 1: Intervention group1 : stapedotomy using 0.4 mm diameter teflon piston prosthesis. Intervention 2: Intervention group2 : stapedotomy using 0.6 mm diameter teflon piston prosthesis.

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: History of progressive hearing loss and tinnitus Normal otoscopic findings Conductive hearing loss more than 20 db at 0.5-4 KHz frequencies and absence of acoustic reflex in audiometry Negative rhinne test by 512-Hz fork

Exclusion criteria

Exclusion criteria: History of ipsilateral stapes surgery Medical disease causing tinnitus Use of drugs causing tinnitus History of ipsilateal ear trauma History of ipsilateral chronic otitis media Otosclerosis with malleus fixation Congenital stapes fixation

Design outcomes

Primary

MeasureTime frame
Tinnitus severity based on tinnitus handicap inventory questionnaire. Timepoint: Assessment of tinnitus severity before and 3 months after stapedotomy. Method of measurement: tinnitus handicap inventory questionnaire.

Secondary

MeasureTime frame
Inprovement of conductive hearing loss. Timepoint: Before and 3 months after stapedotomy. Method of measurement: Pure tone audiometry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactImaneh Roshan Zamir

Mashhad University of Medical Sciences

Roshanzamiri931@mums.ac.ir+98 51 3893 7140

Outcome results

None listed

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