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comparing hearing result between two prosthesis teflon-piston and softclip

Comparison hearing result between fluoroplastic (Teflon) Causse Loop Piston and titanium Soft Clip in patient underwent stapedotomy in 2015 in Dastgheib university Hospital

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014012115496N5
Enrollment
120
Registered
2015-09-11
Start date
2015-06-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

otosclerosis. Otosclerosis involving oval window, nonobliterative

Interventions

Intervention 1: stapedotomy with Flouroplastic(teflon) causse loop piston prosthesis in intervention group 1. Intervention 2: stapedotomy with titanium soft clip prosthesis in intervention group 2.
Treatment - Surgery
stapedotomy with Flouroplastic(teflon) causse loop piston prosthesis in intervention group 1
stapedotomy with titanium soft clip prosthesis in intervention group 2

Sponsors

Vice chancellor for research Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: inclusion criteria:patients who suffered from otosclerosis and underwent stapedotomy with fluoroplastic (teflon) Causse Loop Piston prosthesis or titanium soft clip. exclusion criteria:: 1) All Patients who underwent stapedectomy; 2) Revision cases; 3) Patients who underwent stapedotomy for reasons other than otosclerosis, such as: congenital stapes fixation, malleus head fixation, trauma, chronic otitis media, and tympanosclerosis plaque; 4) Inadequate follow-up(less than 6 months) after surgery.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
ABG(air-bone gap). Timepoint: preoperative and 6 month postoperative. Method of measurement: audiometery(gap between air and bone conduction).;SRT(speech reception threshold). Timepoint: preoperative and 6 month postoperative. Method of measurement: audiometery.;SDS(speech discrimination score). Timepoint: preoperative and 6 month postoperative. Method of measurement: audiometery.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBasir Hashemi

Vice Chancellor for Research of Shiraz University of Medical Sciences

vcrdep@sums.ac.ir+98 71 3235 7282

Outcome results

None listed

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