Comparison of the stability of bioabsorbable and titanium osteosynthesis materials for rigid internal fixation in orthognathic surgery. A prospective randomized controlled study in 101 patients with 192 osteotomies.

The purpose of this study was to evaluate the stability of rigid internal fixation in orthognathic surgery with either bioabsorbable or titanium osteosynthesis. Orthognathic surgery was performed on 101 patients. Bilateral sagittal ramus osteotomy was performed on 55 patients using bioabsorbable osteosynthesis in 26 and titanium osteosynthesis in 29 patients. Le Fort I osteotomy was performed on 28 patients with bioabsorbable and titanium osteosynthesis in 17 and 11 patients, respectively. Bimaxillary osteotomies were performed on 18 patients (8 were fixated with bioabsorbable and 10 with titanium osteosynthesis). Poly-70L/30DL-lactide copolymer (PLDLA) consisting of 70% L-lactide and 30% DL-lactide was used as the bioabsorbable osteosynthesis material. These plates and screws were compared with corresponding titanium materials. Statistically a clear relapse tendency was seen in skeletal measurements in all patient groups but without clinical importance. Radiological follow-up time was at least 18.3 months and clinical follow-up time at least 6.3 years. The materials used did not cause any adverse reaction except in three cases, one in the bioabsorbable group and two in the titanium group where fistula in connection with the osteosynthesis material was noted resulting in removal of the materials.

RCT Entities:   Population Interventions Outcomes