Esposito Marco, Worthington Helen V
Cochrane Database Syst Rev. 2013 Sep 30;2013(9):CD003603. doi: 10.1002/14651858.CD003603.pub3.
Dental implants offer one way to replace missing teeth. Patients who have undergone radiotherapy and those who have also undergone surgery for cancer in the head and neck region may particularly benefit from reconstruction with implants. Hyperbaric oxygen therapy (HBO) has been advocated to improve the success of implant treatment in patients who have undergone radiotherapy but this remains a controversial issue.
To compare the success, morbidity, patient satisfaction and cost effectiveness of dental implant treatment carried out with and without HBO in irradiated patients.
The following electronic databases were searched: the Cochrane Oral Health Group's Trials Register (to 17 June 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 5), MEDLINE via OVID (1946 to 17 June 2013) and EMBASE via OVID (1980 to 17 June 2013). No restrictions were placed on the language or date of publication when searching the electronic databases. We checked the bibliographies of relevant clinical trials and review articles for studies outside the searched journals. We wrote to authors of the identified randomised controlled trials (RCTs) and to more than 55 oral implant manufacturers; we used personal contacts and we made a request on an internet discussion group in an attempt to identify unpublished or ongoing RCTs.
Randomised controlled trials (RCTs) of HBO therapy for irradiated patients requiring dental implants.
Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted in duplicate and independently by two review authors. Results were analysed using random-effects models to determine mean differences for continuous outcomes and risk ratios for dichotomous outcomes, with 95% confidence intervals.
Only one RCT, providing very low quality evidence, was identified and included. Thirteen patients received HBO therapy while another 13 did not. Two to six implants were placed in people with fully edentulous mandibles to be rehabilitated with bar-retained overdentures. One year after implant loading, four patients had died from each group. One patient, treated with HBO, developed an osteoradionecrosis and lost all implants so the prosthesis could not be provided. Five patients in the HBO group had at least one implant failure versus two in the control group. There were no statistically significant differences for prosthesis and implant failures, postoperative complications and patient satisfaction between the two groups.
AUTHORS' CONCLUSIONS: Despite the limited amount of clinical research available, it appears that HBO therapy in irradiated patients requiring dental implants may not offer any appreciable clinical benefits. There is a definite need for more RCTs to ascertain the effectiveness of HBO in irradiated patients requiring dental implants. These trials ought to be of a high quality and reported as recommended by the CONSORT statement (www.consort-statement.org/). Each clinical centre may have limited numbers of patients and it is likely that trials will need to be multicentred.
牙种植体为缺失牙的修复提供了一种方法。接受过放射治疗的患者以及头颈部癌症手术患者可能特别受益于种植体重建。高压氧治疗(HBO)已被提倡用于提高接受过放射治疗患者的种植治疗成功率,但这仍然是一个有争议的问题。
比较在接受过放射治疗的患者中,进行或不进行HBO治疗的牙种植治疗的成功率、发病率、患者满意度和成本效益。
检索了以下电子数据库:Cochrane口腔健康组试验注册库(至2013年6月17日)、Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》2013年第5期)、通过OVID检索的MEDLINE(1946年至2013年6月17日)以及通过OVID检索的EMBASE(1980年至2013年6月17日)。检索电子数据库时对语言或出版日期没有限制。我们查阅了相关临床试验和综述文章的参考文献,以查找检索期刊之外的研究。我们写信给已识别的随机对照试验(RCT)的作者以及55多家口腔种植体制造商;我们利用个人联系,并在一个互联网讨论组上发出请求,试图识别未发表或正在进行的RCT。
针对需要牙种植体的接受过放射治疗患者的HBO治疗的随机对照试验(RCT)。
两名综述作者独立且重复地进行合格研究的筛选、试验方法学质量评估和数据提取。使用随机效应模型分析结果,以确定连续结局的平均差异和二分结局的风险比,并给出95%置信区间。
仅识别并纳入了一项RCT,提供的证据质量极低。13名患者接受了HBO治疗,另有13名未接受。在全口无牙下颌骨患者中植入2至6枚种植体,采用杆卡式覆盖义齿进行修复。种植体加载后一年,每组各有4名患者死亡。一名接受HBO治疗的患者发生放射性骨坏死,所有种植体均丢失,因此无法提供修复体。HBO组有5名患者至少有一枚种植体失败,而对照组为2名。两组在修复体和种植体失败、术后并发症及患者满意度方面无统计学显著差异。
尽管现有临床研究数量有限,但对于需要牙种植体的接受过放射治疗患者,HBO治疗似乎并未带来任何明显的临床益处。显然需要更多RCT来确定HBO在需要牙种植体的接受过放射治疗患者中的有效性。这些试验应具有高质量,并按照CONSORT声明(www.consort-statement.org/)的建议进行报告。每个临床中心的患者数量可能有限,试验可能需要多中心进行。