The current system of choice of fixation system for orthognathic surgery is titanium osteosynthesis but do have some disadvantages. Biodegradable osteosynthesis composed of degradable polymers are available and may reduce removal rates but have other limitations. Studies comparing biodegradable and titanium osteosynthesis have been conducted but the results are conflicting.
The aim of this review was to assess the efficacy and morbidity of biodegradable vs. titanium osteosyntheses in orthognathic surgery
Searches were conducted in the African Journals Online, Cochrane Central Register of Controlled Trials (CENTRAL), EBSCOhost, Embase, PubMed, Scopus, Web of Science, OpenGrey and ClinicalTrials.gov databases. Randomised controlled trials (RCTs), prospective studies and retrospective studies with a control group were considered. Two reviewers independently selected studies and assessed risk of bias, The Revised Cochrane risk-of-bias tool (RoB 2) was used for RCTs and the Methodological Index for Non-Randomized Studies (MINORS) for non-randomised studies. The primary outcome was efficacy of fixation method, i.e. adequate bone healing with the absence of malunion of bone segments at 12 weeks follow-up. Binary outcomes were presented as risk ratio (RR) and 95% confidence intervals (CI) and continuous variables as standardised mean difference (SMD), with 95% CI. Meta-analyses were performed using random-effects models.
- 33 studies (14 RCTs, 3 prospective cohorts, 16 retrospective cohorts. involving 2551 patients (1391 titanium, 1160 biodegradable osteosyntheses) were included.
- Patients ages ranges from 16-57
- 5 studies included orthognathic and trauma patients.
- None of the RCTs were at low risk of bias, 7 had some concerns and 7 were at high risk of bias.
- Qualitative analysis suggests no differences in malunion between titanium and biodegradable osteosyntheses.
- Meta-analysis found no differences between titanium and biodegradable osteosyntheses for a range of secondary outcomes (see table).
|No. of studies||RR (95%CI)|
|Mobility of bone segments||2||1.37 (0.47 to 3.99)|
|Malocclusion||3||0.93 (0.39 to 2.26)|
|Symptomatic plate/screw removal||7||1.29 (0.68 to 2.44)|
|Infection within 4 weeks||8||1.03 (0.46 to 2.28)|
|Revision surgery||4||1.40 (0.37. to 5.34)|
- The operative time was longer in the biodegradable group SMD = 0.50 (0.09 to 0.91) [2 studies].
The authors concluded: –
Biodegradable osteosyntheses is a valid alternative to titanium osteosyntheses for orthognathic surgery, but with longer operation times. Since the quality of evidence varied from very low to moderate, high-quality research is necessary to elucidate the potential of biodegradable osteosyntheses.
The authors registered their protocol on PSOSPERO and searched a broad range of database and provide a qualitative summary of the patient and procedural characteristics on the included studies. With a good number of RCTs identified by the search perhaps inclusion could have been limited to RCTs only, although none of the included RCTs was at low risk og bias. They also note 4 of the 14 publications from RCTs came from the same trial at different time points. A 2017 Cochrane review of this topic by Agnihotry et al (Dental Elf – 20th Oct 2017) only included 2 RCTs only one of which is included in this new review and specifically excluded 4 of the RCTs that have been included. While the findings suggest no differences between biodegradable and titanium osteosynthesis additional high quality RCTs, reporting common outcomes and of appropriate size and duration including patient relevant outcomes are needed.
Gareb B, van Bakelen NB, Dijkstra PU, Vissink A, Bos RRM, van Minnen B. Efficacy and morbidity of biodegradable versus titanium osteosyntheses in orthognathic surgery: A systematic review with meta-analysis and trial sequential analysis. Eur J Oral Sci. 2021 Jun 15:e12800. doi: 10.1111/eos.12800. Epub ahead of print. PMID: 34131965.
Dental Elf – 20th Oct 2017