Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial.
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...
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2017-01-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC5426637?pdf=render |
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| author | B Gareb N B van Bakelen G J Buijs J Jansma J G A M de Visscher Th J M Hoppenreijs J E Bergsma B van Minnen B Stegenga R R M Bos |
| author_facet | B Gareb N B van Bakelen G J Buijs J Jansma J G A M de Visscher Th J M Hoppenreijs J E Bergsma B van Minnen B Stegenga R R M Bos |
| author_sort | B Gareb |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T12:36:35Z |
| format | Article |
| id | doaj.art-583526373998498a8d71bdac188d761f |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-12T12:36:35Z |
| publishDate | 2017-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-583526373998498a8d71bdac188d761f2022-12-22T00:24:19ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01125e017715210.1371/journal.pone.0177152Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial.B GarebN B van BakelenG J BuijsJ JansmaJ G A M de VisscherTh J M HoppenreijsJ E BergsmaB van MinnenB StegengaR R M BosBACKGROUND: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.http://europepmc.org/articles/PMC5426637?pdf=render |
| spellingShingle | B Gareb N B van Bakelen G J Buijs J Jansma J G A M de Visscher Th J M Hoppenreijs J E Bergsma B van Minnen B Stegenga R R M Bos Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial. PLoS ONE |
| title | Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial. |
| title_full | Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial. |
| title_fullStr | Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial. |
| title_full_unstemmed | Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial. |
| title_short | Comparison of the long-term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery: A multicenter randomized controlled trial. |
| title_sort | comparison of the long term clinical performance of a biodegradable and a titanium fixation system in maxillofacial surgery a multicenter randomized controlled trial |
| url | http://europepmc.org/articles/PMC5426637?pdf=render |
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