Trial reportBioMed research international2015
Cutaneous and Labyrinthine Tolerance of Bioactive Glass S53P4 in Mastoid and Epitympanic Obliteration Surgery: Prospective Clinical Study.
Trial report in BioMed research international, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.
- Clinical Use of S53P4 Bioactive Glass in the Treatment of Bone Defects and Infected Bone: A Systematic Review of the Quality of Clinical Outcomes and A Grade Assessment.Advanced healthcare materials · 2026Pooled it
- Heterologous Materials Are Really Better than Autologous in Tympanoplasty Mastoid Obliteration? A Systematic Review with Meta-Analysis.The journal of international advanced otology · 2024Pooled it
- Reducing cerebrospinal fluid leak in vestibular schwannoma surgery via a retrosigmoid approach: a retrospective clinical study.Acta neurochirurgica · 2025Article
- Antibiotics in mastoid and epitympanic obliteration with S53P4 bioactive glass: A retrospective study.Laryngoscope investigative otolaryngology · 2022Article
- Sublabial bioactive glass implantation for the management of primary atrophic rhinitis and empty nose syndrome: Operative technique.Laryngoscope investigative otolaryngology · 2022Article
- Disease-specific quality of life and psychological distress after endoscopic tympanoplasty.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2022Article
- The bony obliteration tympanoplasty in cholesteatoma: safety, hygiene and hearing outcome: allograft versus autograft tympanic membrane reconstruction.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2021Article
- A Multicenter Retrospective Case Review of Outcomes and Complications of S53P4 Bioactive Glass.The journal of international advanced otology · 2021Article
- Implantation of the Bonebridge BCI 602 after Mastoid Obliteration with S53P4 Bioactive Glass: A Safe Method of Treating Difficult Anatomical Conditions-Preliminary Results.Life (Basel, Switzerland) · 2021Article
- Management of tegmen defects with mastoid and epitympanic obliteration using S53P4 bioactive glass.Laryngoscope investigative otolaryngology · 2020Article
- Bioactive glass granules for mastoid and epitympanic surgical obliteration: CT and MRI appearance.European radiology · 2019Observational
- Quality of life and functional results in canal wall down vs canal wall up mastoidectomy.Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale · 2019Article
- Anatomical and functional results of ossiculoplasty using titanium prosthesis.Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale · 2018Article
- Bioactive glass obliteration of the mastoid significantly improves surgical outcome in non-cholesteatomatous chronic otitis media patients.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2017Article
Corrections and comments
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the cutaneous and the inner ear tolerance of bioactive glass S53P4 when used in the mastoid and epitympanic obliteration for chronic otitis surgery. MATERIAL AND
methodsForty-one cases have been included in this prospective study. Cutaneous tolerance was clinically evaluated 1 week, 1 month, and 3 months after surgery with a physical examination of the retroauricular and external auditory canal (EAC) skin and the presence of otalgia; the inner ear tolerance was assessed by bone-conduction hearing threshold 1 day after surgery and by the presence of vertigo or imbalance.
resultsAll surgeries but 1 were uneventful: all patients maintained the preoperative bone-conduction hearing threshold except for one case in which the round window membrane was opened during the dissection of the cholesteatoma in the hypotympanum and this led to a dead ear. No dizziness or vertigo was reported. Three months after surgery, healing was achieved in all cases with a healthy painless skin. No cases of revision surgery for removal of the granules occurred in this study.
conclusionThe bioactive glass S53P4 is a well-tolerated biomaterial for primary or revision chronic otitis surgery, as shown by the local skin reaction which lasted less than 3 months and by the absence of labyrinthine complications.
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