OBJECTIVE: Biodegradable materials are particularly useful for the fixation of zygomatic fractures. Different systems are commercially available. The aim of this study was to compare the clinical outcome of zygomatic fracture fixation using 3 biodegradable systems and a titanium osteosynthesis system. STUDY DESIGN:Patients with displaced fractures of the zygomatic bone presenting at our department from October 2001 to May 2003 were randomly allocated to 1 of 3 treatment groups for fracture fixation (study group A: LactoSorb: n = 18; study group B: BioSorb: n = 18; study group C: Delta: n = 18). Treatment outcome and complication rates were compared with a historic patient group with zygomatic fractures fixed with titanium osteosynthesis (control group D: n = 15). RESULTS: A total of 64 patients (study groupsA + B + C: n = 49; control group D: n = 15) were followed for at least 24 months (range: 24 to 44 months). Forty-nine patients in the biodegradable study groups (group A: n = 15; group B: n = 17; group C: n = 17) who had their fractures fixed withbiodegradable plates and screws alone or in combination with titanium plates and screws were reviewed postoperatively. Uneventful healing occurred during the entire follow-up period in 39 (80%) out of 49 patients in the biodegradable groups (A + B + C) and in 12 (80%) out of 15 patients in group D. Ten patients in groups A + B + C developed postoperative complications (infection: n = 3; soft tissue dehiscence: n = 2; implant-related tissue reactions: n = 5), compared with 3 patients in group D (soft tissue dehiscence: n = 1; unspecific pain: n = 2) (P = .97). Complications occurred in 4 patients in group A and 3 patients each in groups B and C. Smokers developed significantly more postoperative complications than nonsmokers in groups A + B + C (P = .01). CONCLUSION: There was no significant difference between biodegradable osteosynthesis materials or between biodegradable materials and titanium fixation with respect to fracture healing and postoperative complications. Postoperative complications were of a minor nature and resolved spontaneously or after local therapy. Smoking habits may play a significant role in the incidence of complications with biodegradable materials.
RCT Entities:
OBJECTIVE: Biodegradable materials are particularly useful for the fixation of zygomatic fractures. Different systems are commercially available. The aim of this study was to compare the clinical outcome of zygomatic fracture fixation using 3 biodegradable systems and a titanium osteosynthesis system. STUDY DESIGN:Patients with displaced fractures of the zygomatic bone presenting at our department from October 2001 to May 2003 were randomly allocated to 1 of 3 treatment groups for fracture fixation (study group A: LactoSorb: n = 18; study group B: BioSorb: n = 18; study group C: Delta: n = 18). Treatment outcome and complication rates were compared with a historic patient group with zygomatic fractures fixed with titanium osteosynthesis (control group D: n = 15). RESULTS: A total of 64 patients (study groups A + B + C: n = 49; control group D: n = 15) were followed for at least 24 months (range: 24 to 44 months). Forty-nine patients in the biodegradable study groups (group A: n = 15; group B: n = 17; group C: n = 17) who had their fractures fixed with biodegradable plates and screws alone or in combination with titanium plates and screws were reviewed postoperatively. Uneventful healing occurred during the entire follow-up period in 39 (80%) out of 49 patients in the biodegradable groups (A + B + C) and in 12 (80%) out of 15 patients in group D. Ten patients in groups A + B + C developed postoperative complications (infection: n = 3; soft tissue dehiscence: n = 2; implant-related tissue reactions: n = 5), compared with 3 patients in group D (soft tissue dehiscence: n = 1; unspecific pain: n = 2) (P = .97). Complications occurred in 4 patients in group A and 3 patients each in groups B and C. Smokers developed significantly more postoperative complications than nonsmokers in groups A + B + C (P = .01). CONCLUSION: There was no significant difference between biodegradable osteosynthesis materials or between biodegradable materials and titanium fixation with respect to fracture healing and postoperative complications. Postoperative complications were of a minor nature and resolved spontaneously or after local therapy. Smoking habits may play a significant role in the incidence of complications with biodegradable materials.
Authors: Bianca Cristina Lopes da Silva; Debora Souto-Souza; Glaciele Maria de Souza; Rafael Alvim Magesty; Bruna de Cassia Ávila; Endi Lanza Galvão; Saulo Gabriel Moreira Falci Journal: Oral Maxillofac Surg Date: 2021-01-04