1. Comparison of biodegradable and titanium fixation systems in maxillofacial surgery: a two-year multi-center randomized controlled trial.
- Author
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van Bakelen NB, Buijs GJ, Jansma J, de Visscher JG, Hoppenreijs TJ, Bergsma JE, Stegenga B, and Bos RR
- Subjects
- Adolescent, Adult, Dental Occlusion, Device Removal, Facial Bones injuries, Facial Bones surgery, Female, Follow-Up Studies, Fracture Fixation, Internal methods, Humans, Male, Mandible physiology, Mandibular Fractures surgery, Maxillary Fractures surgery, Middle Aged, Orthognathic Surgical Procedures methods, Osteotomy, Le Fort instrumentation, Osteotomy, Le Fort methods, Osteotomy, Sagittal Split Ramus instrumentation, Osteotomy, Sagittal Split Ramus methods, Pain Measurement, Pain, Postoperative etiology, Skull Fractures surgery, Time Factors, Treatment Outcome, Young Adult, Zygomatic Fractures surgery, Absorbable Implants, Biocompatible Materials chemistry, Fracture Fixation, Internal instrumentation, Orthognathic Surgical Procedures instrumentation, Orthopedic Fixation Devices, Titanium chemistry
- 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).
- Published
- 2013
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