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Resorbable versus titanium plates for orthognathic surgery: Cochrane systematic review

Abstract

Background

Recognition of some of the limitations of titanium plates and screws used for the fixation of bones has led to the development of plates manufactured from bioresorbable materials. Whilst resorbable plates appear to offer clinical advantages over metal plates in orthognathic surgery, concerns remain about the stability of fixation and the length of time required for their degradation and the possibility of foreign body reactions. This review compares the use of titanium versus bioresorbable plates in orthognathic surgery and is an update of the Cochrane Review first published in 2007.

Objectives

To compare the effects of bioresorbable fixation systems with titanium systems used during orthognathic surgery.

Search methods

Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 20 January 2017); the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 11) in the Cochrane Library (searched 20 January 2017); MEDLINE Ovid (1946 to 20 January 2017); and Embase Ovid (1980 to 20 January 2017). We searched the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (clinicaltrials.gov; searched 20 January 2017), and the World Health Organization International Clinical Trials Registry Platform (searched 20 January 2017) for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.

Selection criteria

Randomised controlled trials comparing bioresorbable versus titanium fixation systems used for orthognathic surgery in adults.

Data collection and analysis

Two review authors independently screened the results of the electronic searches, extracted data and assessed the risk of bias of the included studies. We resolved disagreement by discussion. Clinical heterogeneity between the included trials precluded pooling of data, and only a descriptive summary is presented.

Main results

This review included two trials, involving 103 participants, one comparing titanium with resorbable plates and screws and the other titanium with resorbable screws. Both studies were at high risk of bias and provided very limited data for the primary outcomes of this review. All participants in one trial suffered mild to moderate postoperative discomfort with no statistically significant difference between the two plating groups at different follow-up times. Mean scores of patient satisfaction were 7.43 to 8.63 (range 0 to 10) with no statistically significant difference between the two groups throughout follow-up. Adverse effects reported in one study were two plate exposures in each group occurring between the third and ninth months. Plate exposures occurred mainly in the posterior maxillary region, except for one titanium plate exposure in the mandibular premolar region. Known causes of infection were associated with loosened screws and wound dehiscence with no statistically significant difference in the infection rate between titanium (3/196), and resorbable (3/165) plates.

Authors' conclusions

We do not have sufficient evidence to determine if titanium plates or resorbable plates are superior for fixation of bones after orthognathic surgery. This review provides insufficient evidence to show any difference in postoperative pain and discomfort, level of patient satisfaction, plate exposure or infection for plate and screw fixation using either titanium or resorbable materials.

Author(s)

Agnihotry Anirudha, Fedorowicz Zbys, Nasser Mona, Gill Karanjot S

Summary

Resorbable versus titanium plates for corrective jaw surgery

Review question

Are resorbable (biodegradable) plates better than titanium (metal) plates for the fixation of facial bones after corrective (orthognathic) jaw surgery?

Background

Under- or overgrowth of one or both of the jaw bones can lead to reduced function and an unattractive facial appearance, either of which may have lasting and significant psychosocial effects. Treatment of severe cases may require a combination of orthodontic appliances and orthognathic (corrective jaw) surgery. After surgery the cut bone needs to be immobilised to ensure that optimal healing takes place. Titanium plates used for fixation are recognised to be the 'gold standard' but recent developments in biomaterials have led to an increased use of bioresorbable plates or screws for corrective jaw surgery. The use of bioresorbable plates for the fixation of facial bones might appear to reduce the need for a further operation for the removal of metal plates. However, whilst resorbable plates do appear to offer certain advantages over metal plates, concerns remain about the stability of fixation, the length of time required for their resorption (being reabsorbed), the possibility of foreign body reactions, and with some of the technical difficulties experienced with resorbable plates.

Study characteristics

We included two studies that analysed a total of 103 participants. The evidence in this review is up to date as of 20 January 2017. Study participants were adults older than 16 years of age. One study compared titanium with resorbable plates and screws and the other titanium with resorbable screws. One study was conducted in China, the other in Germany.

Key results

Both studies were at high risk of bias and provided very limited data. We do not have sufficient evidence to determine if titanium plates or resorbable plates are superior for the fixation of bones after corrective jaw surgery. This review provides insufficient evidence to show any difference in postoperative pain and discomfort, level of patient satisfaction, plate exposure or infection for plate and screw fixation using either titanium or resorbable materials.

Quality of the evidence

Both included studies were assessed as being at high risk of bias and the very limited and weak evidence was of very low quality.

Reviewer's Conclusions

Implications for practice

We do not have sufficient evidence to determine if titanium plates or resorbable plates are superior for fixation of bones after orthognathic surgery. This review provides insufficient evidence to show any difference in postoperative pain and discomfort, level of patient satisfaction, plate exposure or infection for plate and screw fixation using either titanium or resorbable materials.

Implications for research

The results of this systematic review confirm the necessity for further larger sampled, methodologically sound trials that are reported according to the CONSORT statement (www.consort-statement.org/). Although further research is required, the possibility exists that well-informed patients may be unwilling to consent unwittingly to enrolment into a trial where they may be allocated to titanium plating, more especially if there is likely to be a requirement for follow-up surgery to remove the titanium plates after healing has taken place.

Trialists should recognise and try to ensure that any patient-reported outcomes, especially if used to measure pain, are supported by a validated and internationally recognised pain scale that has the discriminatory capacity in terms of both bandwidth and fidelity appropriate for this type of intervention. The value of these patient-reported outcomes could be further enhanced by trialists reporting the type, amount and frequency of any analgesia used to control and relieve postoperative pain. In addition, consideration should be given to the inclusion of outcome measures that assess the ability of patients to eat, swallow and speak, as well as any other postoperative functional disabilities which might arise after orthognathic surgery.

To help minimise the effects of systematic bias in outcome assessment it would be prudent if in future trials the trialists or the surgeons carrying out the intervention are not included as evaluators of outcomes and that appropriate training is given to independent assessors to ensure standardisation of criteria to be used in any outcome assessments.

Costs, not least of all in low- to middle-income countries, are an important consideration in the provision of care and therefore it would be beneficial if future randomised controlled trials for this research question could provide more information on the costs of materials, equipment used with each of the fixation systems, and direct and indirect costs related to hospitalisation and lost time from work or employment.

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Citation

"Resorbable Versus Titanium Plates for Orthognathic Surgery: Cochrane Systematic Review." Cochrane Abstracts, Evidence Central, evidence.unboundmedicine.com/evidence/view/Cochrane/433953/all/Resorbable_versus_titanium_plates_for_orthognathic_surgery:_Cochrane_systematic_review. Accessed 17 July 2019.
Resorbable versus titanium plates for orthognathic surgery: Cochrane systematic review. Cochrane Abstracts. https://evidence.unboundmedicine.com/evidence/view/Cochrane/433953/all/Resorbable_versus_titanium_plates_for_orthognathic_surgery:_Cochrane_systematic_review. Accessed July 17, 2019.
Resorbable versus titanium plates for orthognathic surgery: Cochrane systematic review. In Cochrane Abstracts. Available from https://evidence.unboundmedicine.com/evidence/view/Cochrane/433953/all/Resorbable_versus_titanium_plates_for_orthognathic_surgery:_Cochrane_systematic_review
Resorbable Versus Titanium Plates for Orthognathic Surgery: Cochrane Systematic Review [Internet]. In: Cochrane Abstracts. [cited 2019 July 17]. Available from: https://evidence.unboundmedicine.com/evidence/view/Cochrane/433953/all/Resorbable_versus_titanium_plates_for_orthognathic_surgery:_Cochrane_systematic_review.
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