title: Comparison of biodegradable and titanium fixation systems in maxillofacial surgery: a two-year multi-center randomized controlled trial.
abstract: Biodegradable osteosynthesis could reduce/delete the problems associated with titanium plate removal. The aim of the present study was to compare the clinical performance in the first 2 post-operative years between a biodegradable and a titanium system in oral and maxillofacial surgery. The multicenter randomized controlled trial (RCT) was performed in the Netherlands from December 2006 to July 2009. Included were 230 patients who underwent a bilateral sagittal split osteotomy (BSSO) and/or a Le Fort-I osteotomy and those treated for fractures of the mandible, maxilla, or zygoma. The patients were randomly assigned to a titanium group (KLS Martin) or to a biodegradable group (Inion CPS). Plate removal was necessary in 16 of the 134 patients (11.9%) treated with titanium and in 21 of the 87 patients (24.1%) treated with the biodegradable system within the first 2 post-operative years [p = .016, HR biodegradable (95% CI) = 2.2 (1.1-4.2), HR titanium = 1]. Occlusion, VAS, and MFIQ scores showed that both groups had good mandibular function and were (almost) free of pain 1 and 2 years post-operatively (http://controlled-trials.com ISRCTN 44212338).
authors.affiliation: Department of Oral and Maxillofacial Surgery, University Medical Centre Groningen, University of Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands.
authors.forename: N B
authors.initials: NB
authors.lastname: van Bakelen
authors.forename: G J
authors.initials: GJ
authors.lastname: Buijs
authors.forename: J
authors.initials: J
authors.lastname: Jansma
authors.forename: J G A M
authors.initials: JG
authors.lastname: de Visscher
authors.forename: Th J M
authors.initials: TJ
authors.lastname: Hoppenreijs
authors.forename: J E
authors.initials: JE
authors.lastname: Bergsma
authors.forename: B
authors.initials: B
authors.lastname: Stegenga
authors.forename: R R M
authors.initials: RR
authors.lastname: Bos
mesh_terms: D020341:Absorbable Implants; D000293:Adolescent; D000328:Adult; D001672:Biocompatible Materials / Q000737:chemistry*; D003766:Dental Occlusion; D020878:Device Removal; D005147:Facial Bones / Q000293:injuries / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D005593:Fracture Fixation, Internal / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D008334:Mandible / Q000502:physiology; D008337:Mandibular Fractures / Q000601:surgery; D008440:Maxillary Fractures / Q000601:surgery; D008875:Middle Aged; D056948:Orthognathic Surgical Procedures / Q000295:instrumentation* / Q000379:methods; D009984:Orthopedic Fixation Devices; D019340:Osteotomy, Le Fort / Q000295:instrumentation / Q000379:methods; D059229:Osteotomy, Sagittal Split Ramus / Q000295:instrumentation / Q000379:methods; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology; D012887:Skull Fractures / Q000601:surgery; D013997:Time Factors; D014025:Titanium / Q000737:chemistry*; D016896:Treatment Outcome; D055815:Young Adult; D015051:Zygomatic Fractures / Q000601:surgery
chemical_list: D001672:Biocompatible Materials; D014025:Titanium
keywords: maxillofacial injuries; oral surgery; oral surgical procedures; safety; surgical fixation devices; treatment outcome