Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial.

Autor:	Gareb B; Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., van Bakelen NB; Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Buijs GJ; Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Jansma J; Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., de Visscher JGAM; Department of Oral and Maxillofacial Surgery, Medical Centre Leeuwarden, Leeuwarden, The Netherlands., Hoppenreijs TJM; Department of Oral and Maxillofacial Surgery, Rijnstate Hospital Arnhem, Arnhem, The Netherlands., Bergsma JE; Department of Oral and Maxillofacial Surgery, Amphia Hospital Breda, Breda, The Netherlands., van Minnen B; Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Stegenga B; Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.; UMCG Centre for Dentistry and Oral Hygiene, Department Oral Health Care & Clinical Epidemiology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands., Bos RRM; Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
Jazyk:	angličtina
Zdroj:	PloS one [PLoS One] 2017 May 11; Vol. 12 (5), pp. e0177152. Date of Electronic Publication: 2017 May 11 (Print Publication: 2017).
DOI:	10.1371/journal.pone.0177152
Abstrakt:	Background: Biodegradable fixation systems could reduce or eliminate problems associated with titanium removal of implants in a second operation. Aim: The aim of this study was to compare the long-term (i.e. >5 years postoperatively) clinical performance of a titanium and a biodegradable system in oral and maxillofacial surgery. Materials and Methods: The present multicenter Randomized Controlled Trial (RCT) was performed in four hospitals in the Netherlands. Patients treated with a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy, and those treated for fractures of the mandible, maxilla, or zygoma were included from December 2006 to July 2009. The patients were randomly assigned to either a titanium (KLS Martin) or a biodegradable group (Inion CPS). Results: After >5 years postoperatively, plate removal was performed in 22 of the 134 (16.4%) patients treated with titanium and in 23 of the 87 (26.4%) patients treated with the biodegradable system (P = 0.036, hazard ratio (HR) biodegradable (95% CI) = 2.0 (1.05-3.8), HR titanium = 1). Occlusion, VAS pain scores, and MFIQ showed good and (almost) pain free mandibular function in both groups. Conclusion: In conclusion, the performance of the Inion CPS biodegradable system was inferior compared to the KLS Martin titanium system regarding plate/screws removal in the abovementioned surgical procedures. Trial Registration: http://controlled-trials.com ISRCTN44212338.
Databáze:	MEDLINE
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