Randomized control trial for comparison of teflon and titanium piston in stapedotomy
DOI:
https://doi.org/10.18203/issn.2454-5929.ijohns20262376Keywords:
Otosclerosis, Stapedotomy, Teflon piston, Titanium pistonAbstract
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.
References
Chole RA, McKenna M. Pathophysiology of otosclerosis. Otol Neurotol. 2001;22(2):249-57.
Quesnel AM, Ishai R, McKenna MJ. Otosclerosis. Otolaryngol Clin North Am. 2018;51(2):291-303.
Declau F, Van Spaendonck M, Timmermans JP, Michaels L, Liang J, Qiu JP, et al. Prevalence of otosclerosis in an unselected series of temporal bones. Otol Neurotol. 2001;22(5):596-602.
Batson L, Rizzolo D. Otosclerosis: An update on diagnosis and treatment. JAAPA. 2017;30(2):17-22.
Shea JJ Jr. LXVIII Fenestration of the oval window. Ann Otol Rhinol Laryngol. 1958;67(4):932-51.
Häusler R. General history of stapedectomy. In: Otosclerosis and Stapes Surgery. Basel: KARGER; 2007: 1-5.
Zafar N, Huffman KM. Otosclerosis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2024.
Marchese MR, Cianfrone F, Passali GC, Paludetti G. Hearing results after stapedotomy: role of the prosthesis diameter. Audiol Neurootol. 2007;12(4):221-5.
Mangham CA Jr. Nitinol-teflon stapes prosthesis improves low-frequency hearing results after stapedotomy. Otol Neurotol. 2010;31(7):1022-6.
McElveen JT Jr, Tange RA, Naumann IC. Prosthesis selection in stapes surgery. Curr Otorhinolaryngol Rep. 2022;10(1):23-33.
Bansal M. Teflon implants versus titanium implants in stapes surgery. Indian J Otolaryngol Head Neck Surg. 2016;68(1):16-9.
Gulya AJ, Peng KA, Jackson CG, Glasscock ME 3rd. Glasscock-Shambaugh Surgery of the Ear. 6th ed. Shelton (CT): PMPH-USA; 2010.
Borghei P, Mt KA, Heidari R, Saeidi M, Kouhi A. Functional outcomes of stapes surgery with titanium and teflon prosthesis: randomized controlled trial. Available at: https://www.annexpublishers.com. Accessed on 10 January 2026.
Gherasie LM, Zainea V, Hainarosie R, Rusescu A, Ionita IG, Alius RO, et al. Stapes prostheses in otosclerosis surgery: materials, design innovations, and future perspectives. Actuators. 2025;14(10):502.
Faramarzi M, Gilanifar N, Roosta S. Comparison of fluoroplastic Causse loop piston and titanium soft-clip in stapedotomy. Iran J Otorhinolaryngol. 2017;29(90):15-22.
Faramarzi M, Pedramfard P, Roosta S, Kazemi T, Aboughadare H. Evaluating hearing results in stapedotomy: Comparison of fluoroplastic Causse loop piston and Matrix prosthesis. Laryngoscope Investig Otolaryngol. 2021;6(6):1289-95.
Mangham CA Jr. Titanium CliP piston versus platinum-ribbon Teflon piston. Otol Neurotol. 2008;29(1):8-12.
Velankar H, Carvalho C, Vayangankar K. Teflon implants vs titanium implants in stapedotomy - A comparative study. Integr J Med Sci. 2020;7:1-5.
Ghonim M, Abdel-Karem AR, Youssef A, Hany AM, Salem M, Talaat M. Stapedotomy: Does Titanium soft clip prostheses affect outcome? Egypt J Ear Nose Throat Allied Sci. 2023;24(24):1-6.
de Ataíde AL, Bichinho GL, Patruni TM. Avaliação audiométrica após estapedotomia com prótese de titânio do tipo Fisch. Braz J Otorhinolaryngol. 2013;79(3):325-35.
Faramarzi M, Roosta S, Daneshian N. Comparison between fluoroplastic and platinum/ titanium piston in stapedotomy: A prospective, randomized clinical study. J Int Adv Otol. 2020;16(2):234-40.
Immordino A, Marco P, Lorusso F, Sireci F, Immordino P, Gallina S, et al. Comparison between MatriX and mAXIS titanium prosthesis in stapedotomy: prospective study and review of the literature. J Otol. 2025;20(2):93-102.
Wegner I, Verhagen JJ, Stegeman I, Vincent R, Grolman W. A systematic review of the effect of piston diameter in stapes surgery for otosclerosis on hearing results. Laryngoscope. 2016;126(1):182-90.
Downloads
Published
How to Cite
Issue
Section
