Resorbable versus titanium plates for orthognathic surgery

 

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.

Objectives

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

Search methods

We searched the following databases: Cochrane Oral Health Group Trials Register (to 26th January 2006); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2005, Issue 4); MEDLINE (without filter) (from 1966 to 26th January 2006); and EMBASE (without filter) (from 1980 to 26th January 2006).

Selection criteria

Randomised controlled trials comparing resorbable versus titanium fixation systems used for orthognathic surgery.

Data collection and analysis

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 compared titanium with resorbable plates and screws and the other titanium with resorbable screws, both provided very limited data for the primary outcomes of this review. All patients 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 P = 0.83 (published as P = 0.67).

Authors' conclusions

This review provides some evidence to show that there is no statistically significant difference in postoperative discomfort, level of patient satisfaction, plate exposure or infection for plate and screw fixation using either titanium or resorbable materials in orthognathic surgery.

 

Plain language summary

Resorbable versus titanium plates for orthognathic surgery

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 usage of bioresorbable plates or screws for orthognathic surgery.
The use of bioresorbable plates for the fixation of facial bones might appear to reduce the necessity of 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, the possibility of foreign body reactions, and with some of the technical difficulties experienced with resorbable plates.
The authors of the review identified a limited number of randomised controlled trials which addressed only a few of the preferred outcomes and provided some evidence for the effectiveness of resorbable plating systems for orthognathic surgery.
The review authors concluded that future research should aim to provide evidence for people to make informed decisions about whether resorbable plating systems are as effective as titanium ones and that further randomised controlled trials should be well designed and reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement (http://www.consort-statement.org).

 

摘要

背景

可吸收骨板及鈦金屬骨板在正顎手術應用上的比較

由於固定骨頭時使用的鈦金屬板及螺絲具有一些使用上的限制，所以促進了生物可吸收材料的發展。可吸收骨板在臨床上固然有它的好處，但有些方面還是存有疑慮，包括固定骨頭的穩定性，被吸收時間的長短，以及被身體當做外來物而產生一些不良反應的可能性。

目標

比較具有生物可吸收性的固位系統以及鈦金屬板系統分別應用在正顎手術的效果

搜尋策略

我們搜尋以下的資料庫: Cochrane Oral Health Group Trials Register (至 第26期2006一月); the Cochrane Central Register of Controlled Trials (主要) (The Cochrane Library 2005, Issue 4); MEDLINE (未過濾) (從 1966 至 第26期2006一月); and EMBASE (未過濾) (從 1980 至第26期2006年1月)。

選擇標準

在本篇比較具有生物可吸收性的固位系統以及鈦金屬板系統分別應用在正顎手術的效果的文獻中，使用了隨機對照試驗做為選擇標準。

資料收集與分析

在本試驗中的臨床異質性避免了龐雜的數據整理，而只以敘述性的摘要來呈現。

主要結論

這篇回顧的文章包含了兩篇臨床試驗,共有103位參與者，一篇是著重在比較鈦金屬與可吸收的骨板及螺絲之差異，而另一篇是在比較鈦金屬及可吸收的螺絲之差異，兩篇所提供的數據資料都很有限，所以本回顧的文章屬於較初期的結果。不論是使用哪種材料的病人，在術後都有輕微至中度的不適,而且在之後的追蹤中，使用不同材料的病人對於手術後的滿意程度，並沒有顯著的不同。平均的滿意值在7.43∼8.63之間(區間為0∼10)。而在另一篇研究中，在術後3到9個月，兩組中各有兩個病例的骨板暴露。骨板的暴露除了一例發生在下顎小臼齒區外，其餘都發生在上顎後牙區部分。已知的感染原因和鬆脫的螺絲和傷口裂開有關,在感染機率方面使用鈦金屬和可吸收材料這兩組之間並沒有統計上顯著的差異。感染機率分別為:鈦金屬(3/196),可吸收材料(3/165), P = 0.83。

作者結論

這篇回顧文章的結論顯示,在正顎手術中固定的骨板或螺絲，不論是使用可吸收的材料或是鈦金屬、在病人術後的不適、病人的滿意程度、骨板的暴露與否及感染方面都沒有顯著的不同。

翻譯人

本摘要由臺灣大學附設醫院郭俐伶翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

可吸收骨板及鈦金屬骨板在正顎手術應用上的比較。單顎或雙顎骨的過份生長或發育不良可能導致功能受到影響或顏面美觀不佳，而以上兩者都有可能導致嚴重或長期心理層面受創。嚴重的病例需要以矯正合併正顎手術來進行治療。為了達到最理想的預後，手術後被切斷的骨頭必須被牢牢的固定。正顎手術中用來固定的鈦金屬骨板被認為是標準黃金做法，但隨著材料的發展，具生物吸收性的骨板也越來越經常被使用。在未來的手術中，用來固定顏面骨的骨板種類中，可吸收材料的出現可能會使得一些需要術後移除的金屬骨板之使用情形越來越少。然而，雖然可吸收的骨板的確有一些優點，但是仍然有一些疑慮未被釐清，例如:固定骨頭的穩定性，被吸收時間的長短，以及被身體當做外來物而產生一些不良反應的可能性， 或是技術 層面的困難。本作者所回顧的臨床試驗文章並不多，其中對於可吸收骨板的良好效果的證據也很有限。作者的結論是未來的研究應著重於可吸收的骨板系統是否真如鈦金屬骨板一樣有效可靠，以做為手術時選擇材料的參考。後續的臨床試驗需根據Consolidated Standards of Reporting Trials (結盟) statement來審慎設計。(http://www.consortstatement.org