Clinical Outcomes of Bioactive Glass S53P4 in Radical Mastoid Cavity Obliteration

Impact of Quality of Life After Radical Cavity Revision and Obliteration With S53P4 Bioactive Glass Granules

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tympanoplasty
• Intervention / Treatment: Procedure: Mastoid cavity obliteration with S53P4 bioactive glass

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Italy
  • Italy
    • Legnano, Italy, Italy, 20025
      • Trial Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients requiring rehabilitation of radical open cavity after a previous canal wall down tympanoplasty. The trial will include at least 50 consecutives patients whom it is planned rehabilitation of radical cavity and mastoid obliteration with S53P4 Bonalive granules. Patients with a history of canal wall down (CWD) tympanoplasty who present with persistent symptoms such as discharge, vertigo, impaired water activities or difficulty with hearing aids will be included.

Description

Inclusion Criteria:

• underwent a canal wall down tympanoplasty or a previous obliteration attempt more than a year ago
• present with symptoms related to unstable cavity such as discharge, vertigo, impaired water activities or difficulty with hearing aids will be included
• patients Over 18 years who signed informed consent

Exclusion Criteria:

• Active cholesteatoma
• Earlier radiation of Head and Neck area
• Pregnancy
• Important systemic comorbidities

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radical cavity obliteration with S53P4 bioactive glass; Adult patients with symptomatic radical mastoid cavities after previous open tympanoplasty undergoing obliteration using S53P4 bioactive glass.	Procedure: Mastoid cavity obliteration with S53P4 bioactive glass; Surgical obliteration of symptomatic radical mastoid cavities using S53P4 bioactive glass as obliterative material during revision surgery after previous open tympanoplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Improvement After Mastoid Cavity Obliteration With S53P4	Change in quality of life assessed using the Chronic Otitis Media Questionnaire-12 (COMQ-12). The COMQ-12 is a validated questionnaire with total scores ranging from 0 to 60, where higher scores indicate worse quality of life and greater disease severity. The outcome is defined as the mean change in total COMQ-12 score from preoperative assessment to postoperative follow-up. Unit of measure: Points (COMQ-12 score).	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life (GBI score)	Change in quality of life assessed using the Glasgow Benefit Inventory (GBI), a validated questionnaire with scores ranging from -100 to +100, where higher scores indicate greater benefit. The outcome is defined as the mean postoperative GBI total score. Unit of Measure: Points (GBI score)	3 months after surgery
Change in audiometric hearing thresholds	Change from baseline in audiometric hearing thresholds measured by pure-tone audiometry. The outcome is defined as the mean change in hearing threshold levels between preoperative and postoperative assessments. Unit of Measure: Decibels (dB)	3 months after surgery
Resolution of otorrhea	Resolution or improvement of otorrhea assessed clinically and defined as absence of ear discharge at follow-up. Unit of Measure: Percentage of participants	3 months after surgery
Change in cavity volume	Change in cavity volume measured using water filling of the ear canal. The outcome is defined as the difference between preoperative and postoperative cavity volume. Unit of Measure: Milliliters (mL)	3 months after surgery
External auditory canal condition	Condition of the external auditory canal assessed by otoscopy and graded using the Merchant scale, with the objective of achieving a dry ear. Unit of Measure: Merchant scale score from 0 to 4, where 0 indicates no vertigo and 4 indicates severe vertigo with significant disability.	3 months after surgery

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano
• Investigators: Principal Investigator: Matteo Di Bari, MD, Asst Ovest Milanese

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 15, 2027

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: bioactive glass S53P4
• Other Study ID Numbers: 16-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No