Biodegradable versus titanium osteosynthesis in maxillofacial surgery: a randomized controlled trial with 15 years of follow-up
In brief
Biodegradable plates removed in 30% vs 17% with titanium after 15 years
In a 15-year multicenter RCT of 230 patients, symptomatic removal occurred in 29.5% of biodegradable osteosynthesis cases compared with 17.4% of titanium cases, indicating almost double the long-term removal risk. Palpability was higher with titanium, but occlusion, pain and function were similar, leaving the choice between material durability and lower removal rates unresolved.
- Journal
- International journal of oral and maxillofacial surgery (Q1)
- Published
- 17 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- L Veenman, N B van Bakelen, G J Buijs, T J M Hoppenreijs, J E Bergsma, L J Beumer, et al.
- PMID
- 42608236
- DOI
- 10.1016/j.ijom.2026.08.007
Why clinicians should know about it
- Picked for Otorhinolaryngology (top studies of the week, 23 August 2026): RCT comparing biodegradable vs titanium osteosynthesis long term
Abstract
Studies on long-term outcomes of biodegradable versus titanium osteosynthesis in maxillofacial surgery are lacking. This multicentre randomized controlled trial was performed to compare the long-term clinical performance of titanium versus biodegradable osteosynthesis systems at ≥15 years of follow-up. Patients undergoing bilateral sagittal split and/or Le Fort I osteotomies, or treatment for mandible, maxilla, or zygoma fractures at four hospitals were included. Eligible participants (n = 230) were randomly assigned to receive titanium (KLS Martin) or biodegradable (Inion CPS) plates and screws (1:1). The primary outcome was symptomatic osteosynthesis removal. Secondary outcomes included malocclusion, plate palpability, swelling, mandibular function, pain scores, and patient satisfaction. Median follow-up was 16.3 years. Osteosynthesis removal at 15 years was 17.4% in the titanium group and 29.5% in the biodegradable group (hazard ratio 1.88, 95% confidence interval 1.07-3.31, P = 0.028). Notably, 4.5% of titanium group patients required symptomatic removal between 5 years and the latest follow-up, whereas no such removals were needed in the biodegradable group (P = 0.045). Plate palpability was higher in the titanium group (P = 0.004), but no significant difference was found in malocclusion, swelling, pain, or mandibular function scores. Both groups reported high patient satisfaction and excellent function without pain. The intention-to-treat results showed a significantly higher risk of symptomatic osteosynthesis removal after long-term follow-up in the biodegradable group, while the per-protocol analysis revealed a non-significant difference between the groups. There is a lifetime risk of symptomatic titanium plate removal (5% of patients at >5 years of follow-up).
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.