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Tympanoplasty

Tundra lists 3 Tympanoplasty clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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COMPLETED

NCT07806461

Study the Impact of the Mastoid and Middle Ear Volume on the Success of Type 1 Tympanoplasty in Pediatric Age, With Comparing Using Cartilage and Fascial Grafts Through This, Strength the Hypothesis of That Total Tympanometry Volume Correlates With Ventilated Mastoid Air Cells Volume on CT Scans

The goal of this observational study is to know the impact of the mastoid and middle ear volume on the success of type 1 tympanoplasty in pediatric age, with a closer view on the comparison of using cartilage and fascial grafts through this. The investigators also hoping to strength the hypothesis of that total tympanometry volume correlates with ventilated mastoid air cells on Computed Topography (CT) scans that allow us to predict a well-ventilated mastoid air cell system. This may help reduce the need for pre-operative CT scans in uncomplicated cases with tympanic membrane perforations. The main question it aims to answer is: Does Mastoid ventilation affect the success of tympanoplasty (Type 1) in pediatric age group? and which graft is better and if the tympanometry volume (non invasive investigation) correlate with the degree of the mastoid pneumatization degree and volume (based on CT scan and 3D volumetric measuring). Participants already taking intervention a as part of their regular surgical treatment of chronic suppurative otitis media with perforation in the form of Type 1 tympanoplasty (Myringoplasty), informed consent was obtained from all the study participants guardians. Regular postoperative follow up of the success rate (structural success was evaluated 1 month postoperatively) and functional success were evaluated at 1.5 months and 3 months postoperatively.

Gender: All

Ages: 8 Years - 18 Years

Updated: 2026-09-08

1 state

Chronic Suppurative Otitis Media
Mastoid Cavity
Pneumatization
+2
COMPLETED

NCT07698171

Comparison of Results of Myringoplasty Using Biodesign - an Otologic Graft Made From Porcine Small Intestinal Submucosa, Temporalis Fascia, or Tragal Perichondrium - a Retrospective Cohort Analysis

The goal of this observational, retrospective study is to learn whether a ready-made graft patch (Biodesign, made from porcine small intestinal submucosa) works as well as a participant's own tissue graft (such as tragal perichondrium or temporalis fascia) to close a hole in the eardrum (tympanic membrane perforation). The main questions this study aims to answer are: Does the eardrum hole close after surgery, and is the closure rate similar between Biodesign and autologous tissue grafts? Do participants have similar hearing improvement after surgery (measured by the air-bone gap, a common hearing test measure)? Is the operating time different between the graft types? Are there differences in complications or adverse reactions? Study hypothesis: Biodesign will have a similar eardrum closure rate compared with autologous tissue grafts, with similar hearing improvement and low complication rates, and may be associated with a shorter operating time. How the study will work: Investigators will review medical records of participants who had myringoplasty/tympanoplasty for eardrum perforation in the department between 2020 and 2024. Data already recorded as part of usual care will be collected, including: pre-surgery eardrum findings (size and location of the perforation) and hearing tests; operative details (technique and operating time); and follow-up at about 3 months, including an ear exam to confirm closure and check for adverse reactions, plus a hearing test. Participants will be excluded if they have other ear conditions (such as cholesteatoma, otosclerosis, or tympanosclerosis), if the eardrum was described as flaccid, or if follow-up or post-operative hearing data are missing.

Gender: All

Updated: 2026-07-13

Tympanic Membrane Perforation
Tympanoplasty
Myringoplasty
ENROLLING BY INVITATION

NCT07496112

Clinical Outcomes of Bioactive Glass S53P4 in Radical Mastoid Cavity Obliteration

Radical cavities resulting from open tympanoplasty performed for chronic cholesteatomatous otitis may lead to postoperative complications and negatively affect patients' quality of life. These cavities can remain unstable and may be associated with persistent otorrhea, limitations in the use of hearing aids, and the need to avoid water exposure, all of which may significantly impact daily activities. Although mastoid and paratympanic cavity obliteration techniques are increasingly used during primary surgery, many patients previously treated with open tympanoplasty continue to present with problematic postoperative cavities. Obliteration procedures have been proposed in revision surgery to improve cavity stability and reduce complications. Bioactive glass S53P4 has recently attracted interest as an obliterative material due to its long-term stability, biocompatibility, antibacterial properties, and ability to integrate with surrounding tissues. However, evidence regarding the medium-term clinical outcomes of this approach remains limited. The aim of this study is to evaluate the clinical effectiveness and safety of mastoid cavity obliteration using bioactive glass S53P4 in patients with radical cavities following open tympanoplasty. The study will assess surgical success, complication rates, and the impact of the procedure on patient quality of life.

Gender: All

Ages: 18 Years - Any

Updated: 2026-04-03

1 state

Tympanoplasty