Randomized control trial for comparison of teflon and titanium piston in stapedotomy

Abstract

Background: This study aims to compare the improvement in hearing after stapedotomy using Titanium versus Teflon pistons in patients with otosclerosis, and to assess postoperative auditory and vestibular symptoms, such as tinnitus and vertigo, in both groups.

Methods: A randomized controlled trial was carried over a period of 12 months.44 patients aged 18-60 with otosclerosis were divided into 2 groups by random allocation. Group A was subjected to stapedotomy with Teflon piston and group B received Titanium piston. All patients were followed up post operatively at 3, 6 and 12 weeks, to assess audiological outcomes and post-operative symptoms.  

Results: The mean pre-operative air-bone gap (ABG) was 32.95±4.83 dB in the Teflon group and 33.23±5.19 dB in the Titanium group, with no significant difference. At 3 and 6 weeks post operatively, mean ABG further improved parallelly in both groups. At 12 weeks, final mean ABG was 9.68±3.03 dB in the Teflon group and 11.05±3.86 dB in the Titanium group, with no statistically significant difference. Excellent ABG closure (≤10 dB) was achieved in 72.7% of Teflon patients and 59.1% of Titanium patients. Post op tinnitus and vertigo were also comparable in both groups.

Conclusions: Stapedotomy using either Teflon or Titanium piston prostheses results in significant and clinically meaningful improvement in hearing among patients with otosclerosis. Thus, both pistons can be effectively used based on availability and practical considerations to achieve excellent functional hearing outcomes when meticulous surgical technique is employed.