Cochrane Oral Health, Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.
Health Technol Assess. 2020 Feb;24(7):1-224. doi: 10.3310/hta24070.
Splints are a non-invasive, reversible management option for temporomandibular disorders or bruxism. The clinical effectiveness and cost-effectiveness of splints remain uncertain.
The objectives were to evaluate the clinical effectiveness and cost-effectiveness of splints for patients with temporomandibular disorders or bruxism. This evidence synthesis compared (1) all types of splint versus no/minimal treatment/control splints and (2) prefabricated versus custom-made splints, for the primary outcomes, which were pain (temporomandibular disorders) and tooth wear (bruxism).
Four databases, including MEDLINE and EMBASE, were searched from inception until 1 October 2018 for randomised clinical trials. The searches were conducted on 1 October 2018. Cochrane review methods (including risk of bias) were used for the systematic review. Standardised mean differences were pooled for the primary outcome of pain, using random-effects models in temporomandibular disorder patients. A Markov cohort, state-transition model, populated using current pain and Characteristic Pain Intensity data, was used to estimate the incremental cost-effectiveness ratio for splints compared with no splint, from an NHS perspective over a lifetime horizon. A value-of-information analysis identified future research priorities.
Fifty-two trials were included in the systematic review. The evidence identified was of very low quality with unclear reporting by temporomandibular disorder subtype. When all subtypes were pooled into one global temporomandibular disorder group, there was no evidence that splints reduced pain [standardised mean difference (at up to 3 months) -0.18, 95% confidence interval -0.42 to 0.06; substantial heterogeneity] when compared with no splints or a minimal intervention. There was no evidence that other outcomes, including temporomandibular joint noises, decreased mouth-opening, and quality of life, improved when using splints. Adverse events were generally not reported, but seemed infrequent when reported. The most plausible base-case incremental cost-effectiveness ratio was uncertain and driven by the lack of clinical effectiveness evidence. The cost-effectiveness acceptability curve showed splints becoming more cost-effective at a willingness-to-pay threshold of ≈£6000, but the probability never exceeded 60% at higher levels of willingness to pay. Results were sensitive to longer-term extrapolation assumptions. A value-of-information analysis indicated that further research is required. There were no studies measuring tooth wear in patients with bruxism. One small study looked at pain and found a reduction in the splint group [mean difference (0-10 scale) -2.01, 95% CI -1.40 to -2.62; very low-quality evidence]. As there was no evidence of a difference between splints and no splints, the second objective became irrelevant.
There was a large variation in the diagnostic criteria, splint types and outcome measures used and reported. Sensitivity analyses based on these limitations did not indicate a reduction in pain.
The very low-quality evidence identified did not demonstrate that splints reduced pain in temporomandibular disorders as a group of conditions. There is insufficient evidence to determine whether or not splints reduce tooth wear in patients with bruxism. There remains substantial uncertainty surrounding the most plausible incremental cost-effectiveness ratio.
There is a need for well-conducted trials to determine the clinical effectiveness and cost-effectiveness of splints in patients with carefully diagnosed and subtyped temporomandibular disorders, and patients with bruxism, using agreed measures of pain and tooth wear.
This study is registered as PROSPERO CRD42017068512.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 7. See the NIHR Journals Library website for further project information.
夹板是治疗颞下颌关节紊乱或磨牙症的一种非侵入性、可逆的治疗选择。夹板的临床疗效和成本效益仍不确定。
评估夹板治疗颞下颌关节紊乱或磨牙症患者的临床疗效和成本效益。本证据综合比较了（1）所有类型的夹板与无/最小治疗/对照夹板，以及（2）预制夹板与定制夹板，主要结局是疼痛（颞下颌关节紊乱）和牙齿磨损（磨牙症）。
从成立到 2018 年 10 月 1 日，我们在四个数据库（包括 MEDLINE 和 EMBASE）中进行了随机临床试验搜索。搜索于 2018 年 10 月 1 日进行。使用 Cochrane 综述方法（包括偏倚风险）对系统综述进行了评估。使用随机效应模型对颞下颌关节紊乱患者的疼痛主要结局进行了标准化均数差的汇总。使用当前疼痛和特征性疼痛强度数据，构建了一个马尔可夫队列、状态转移模型，以从 NHS 角度在终生范围内估计与无夹板相比，夹板的增量成本效益比。价值信息分析确定了未来的研究重点。
52 项试验被纳入系统综述。所确定的证据质量非常低，颞下颌关节紊乱亚型的报告不明确。当所有亚型合并为一个全球性的颞下颌关节紊乱组时，与无夹板或最小干预相比，没有证据表明夹板能减轻疼痛[在 3 个月时的标准化均数差（SMD）-0.18，95%置信区间（CI）-0.42 至 0.06；存在显著异质性]。没有证据表明其他结局，包括颞下颌关节噪音、张口度减小和生活质量改善，使用夹板后有所改善。一般不报告不良事件，但报告的不良事件似乎很少见。最合理的增量成本效益比不确定，主要受缺乏临床疗效证据的影响。成本效益接受性曲线表明，在 ≈£6000 的支付意愿阈值下，夹板更具成本效益，但在更高的支付意愿水平下，概率从未超过 60%。结果对长期外推假设敏感。价值信息分析表明需要进一步研究。没有研究测量磨牙症患者的牙齿磨损。一项小型研究观察了疼痛，发现夹板组疼痛减轻[0-10 量表的平均差值（MD）-2.01，95%置信区间（CI）-1.40 至 -2.62；极低质量证据]。由于没有证据表明夹板与无夹板之间存在差异，第二个目标变得无关紧要。
使用和报告的诊断标准、夹板类型和结局测量方法差异很大。基于这些局限性的敏感性分析并没有表明疼痛减轻。
所确定的极低质量证据并没有证明夹板可以减轻作为一组病症的颞下颌关节紊乱的疼痛。没有足够的证据来确定夹板是否可以减少磨牙症患者的牙齿磨损。围绕最合理的增量成本效益比仍存在很大的不确定性。
需要进行精心设计和实施的试验，以确定在经过仔细诊断和分型的颞下颌关节紊乱患者以及磨牙症患者中，夹板的临床疗效和成本效益，使用疼痛和牙齿磨损的公认测量方法。
本研究已在 PROSPERO CRD42017068512 注册。
本项目由英国国家卫生研究所（NIHR）健康技术评估计划资助，将在 ; 第 24 卷，第 7 期。请访问 NIHR 期刊库网站以获取更多项目信息。
