Agnihotry Anirudha, Fedorowicz Zbys, Nasser Mona, Gill Karanjot S
Arthur A Dugoni School of Dentistry, University of the Pacific, 155 5th Street, San Francisco, CA, USA, 94103.
Cochrane Database Syst Rev. 2017 Oct 4;10(10):CD006204. doi: 10.1002/14651858.CD006204.pub3.
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.
To compare the effects of bioresorbable fixation systems with titanium systems used during orthognathic surgery.
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.
Randomised controlled trials comparing bioresorbable versus titanium fixation systems used for orthognathic surgery in adults.
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.
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.
认识到用于骨骼固定的钛板和螺钉存在一些局限性,促使人们研发出由生物可吸收材料制成的骨板。虽然在正颌外科手术中,可吸收骨板似乎比金属骨板具有临床优势,但对于固定稳定性、降解所需时间以及异物反应的可能性仍存在担忧。本综述比较了钛板与可吸收骨板在正颌外科手术中的应用情况,是对2007年首次发表的Cochrane系统评价的更新。
比较正颌外科手术中使用的生物可吸收固定系统与钛系统的效果。
Cochrane口腔健康信息专家检索了以下数据库:Cochrane口腔健康试验注册库(截至2017年1月20日);Cochrane图书馆中的Cochrane系统评价集中对照试验注册库(CENTRAL;2016年第11期,检索于2017年1月20日);MEDLINE Ovid(1946年至2017年1月20日);以及Embase Ovid(1980年至2017年1月20日)。我们检索了美国国立卫生研究院正在进行的试验注册库ClinicalTrials.gov(clinicaltrials.gov;检索于2017年1月20日)以及世界卫生组织国际临床试验注册平台(检索于2017年1月20日)以查找正在进行的试验。检索电子数据库时对语言或出版日期没有限制。
比较生物可吸收与钛固定系统在成人正颌外科手术中应用的随机对照试验。
两位综述作者独立筛选电子检索结果,提取数据并评估纳入研究的偏倚风险。我们通过讨论解决分歧。纳入试验之间的临床异质性排除了数据合并的可能性,因此仅给出描述性总结。
本综述纳入两项试验,涉及103名参与者,一项比较钛板与可吸收骨板及螺钉,另一项比较钛螺钉与可吸收螺钉。两项研究均存在较高偏倚风险,且为本综述的主要结局提供的数据非常有限。一项试验中的所有参与者术后均有轻度至中度不适,两个植骨组在不同随访时间无统计学显著差异。患者满意度的平均得分在7.43至8.63之间(范围为0至10),随访期间两组之间无统计学显著差异。一项研究中报告的不良反应是每组在第3至9个月之间出现两例骨板暴露。骨板暴露主要发生在上颌后部区域,下颌前磨牙区有一例钛板暴露除外。已知的感染原因与螺钉松动和伤口裂开有关,钛板(3/196)和可吸收骨板(3/165)之间的感染率无统计学显著差异。
我们没有足够的证据来确定钛板或可吸收骨板在正颌外科手术后的骨骼固定方面是否更具优势。本综述提供的证据不足,无法表明使用钛或可吸收材料进行骨板和螺钉固定在术后疼痛和不适、患者满意度水平、骨板暴露或感染方面存在任何差异。