Fleming Padhraig S, Strydom Hardus, Katsaros Christos, MacDonald Lci, Curatolo Michele, Fudalej Piotr, Pandis Nikolaos
Barts and The London School of Medicine and Dentistry, Institute of Dentistry, Queen Mary University of London, New Road, London, UK, E1 1BB.
Strydom Orthodontics Inc, 15 Kildare Rd, Newlands, Cape Town, South Africa, 7700.
Cochrane Database Syst Rev. 2016 Dec 23;12(12):CD010263. doi: 10.1002/14651858.CD010263.pub2.
Pain is prevalent during orthodontics, particularly during the early stages of treatment. To ensure patient comfort and compliance during treatment, the prevention or management of pain is of major importance. While pharmacological means are the first line of treatment for alleviation of orthodontic pain, a range of non-pharmacological approaches have been proposed recently as viable alternatives.
To assess the effects of non-pharmacological interventions to alleviate pain associated with orthodontic treatment.
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 6 October 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2016, Issue 9), MEDLINE Ovid (1946 to 6 October 2016), Embase Ovid (1980 to 6 October 2016) and EThOS (to 6 October 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.
Randomised controlled trials (RCTs) comparing a non-pharmacological orthodontic pain intervention to a placebo, no intervention or another non-pharmacological pain intervention were eligible for inclusion. We included any type of orthodontic treatment but excluded trials involving the use of pre-emptive analgesia or pain relief following orthognathic (jaw) surgery or dental extractions in combination with orthodontic treatment. We excluded split-mouth trials (in which each participant receives two or more treatments, each to a separate section of the mouth) and cross-over trials.
At least two review authors independently assessed risk of bias and extracted data. We used the random-effects model and expressed results as mean differences (MD) with 95% confidence intervals (CI). We investigated heterogeneity with reference to both clinical and methodological factors.
We included 14 RCTs that randomised 931 participants. Interventions assessed included: low-level laser therapy (LLLT) (4 studies); vibratory devices (5 studies); chewing adjuncts (3 studies); brain wave music or cognitive behavioural therapy (1 study) and post-treatment communication in the form of a text message (1 study). Twelve studies involved self-report assessment of pain on a continuous scale and two studies used questionnaires to assess the nature, intensity and location of pain.We combined data from two studies involving 118 participants, which provided low-quality evidence that LLLT reduced pain at 24 hours by 20.27 mm (95% CI -24.50 to -16.04, P < 0.001; I² = 0%). LLLT also appeared to reduce pain at six hours, three days and seven days.Results for the other comparisons assessed are inconclusive as the quality of the evidence was very low. Vibratory devices were assessed in five studies (272 participants), four of which were at high risk of bias and one unclear. Chewing adjuncts (chewing gum or a bite wafer) were evaluated in three studies (181 participants); two studies were at high risk of bias and one was unclear. Brain wave music and cognitive behavioural therapy were evaluated in one trial (36 participants) assessed at unclear risk of bias. Post-treatment text messaging (39 participants) was evaluated in one study assessed at high risk of bias.Adverse effects were not measured in any of the studies.
AUTHORS' CONCLUSIONS: Overall, the results are inconclusive. Although available evidence suggests laser irradiation may help reduce pain during orthodontic treatment in the short term, this evidence is of low quality and therefore we cannot rely on the findings. Evidence for other non-pharmacological interventions is either very low quality or entirely lacking. Further prospective research is required to address the lack of reliable evidence concerning the effectiveness of a range of non-pharmacological interventions to manage orthodontic pain. Future studies should use prolonged follow-up and should measure costs and possible harms.
正畸治疗期间疼痛很常见，尤其是在治疗初期。为确保患者在治疗期间的舒适度和依从性，疼痛的预防或管理至关重要。虽然药物治疗是缓解正畸疼痛的一线治疗方法，但最近已提出一系列非药物方法作为可行的替代方案。
评估非药物干预措施减轻正畸治疗相关疼痛的效果。
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2016年10月6日）、Cochrane对照试验中心注册库（CENTRAL）（Cochrane图书馆，2016年第9期）、MEDLINE Ovid（1946年至2016年10月6日）、Embase Ovid（1980年至2016年10月6日）和EThOS（截至2016年10月6日）。我们在ClinicalTrials.gov和世界卫生组织国际临床试验注册平台上检索正在进行的试验。检索电子数据库时，对语言或出版日期没有限制。
比较非药物正畸疼痛干预措施与安慰剂、无干预措施或另一种非药物疼痛干预措施的随机对照试验（RCT）符合纳入标准。我们纳入了任何类型的正畸治疗，但排除了涉及正颌（颌骨）手术或拔牙联合正畸治疗后使用超前镇痛或疼痛缓解的试验。我们排除了双侧对照试验（每位参与者接受两种或更多治疗，每种治疗应用于口腔的不同部位）和交叉试验。
至少两名综述作者独立评估偏倚风险并提取数据。我们使用随机效应模型，并将结果表示为平均差（MD）及95%置信区间（CI）。我们参考临床和方法学因素调查异质性。
我们纳入了14项RCT，共931名参与者。评估的干预措施包括：低强度激光治疗（LLLT）（4项研究）；振动装置（5项研究）；咀嚼辅助物（3项研究）；脑波音乐或认知行为疗法（1项研究）以及以短信形式进行的治疗后沟通（1项研究）。12项研究涉及对疼痛进行连续量表的自我报告评估，2项研究使用问卷评估疼痛的性质、强度和部位。我们合并了两项涉及118名参与者的研究数据，这些数据提供了低质量证据，表明LLLT在24小时时可使疼痛减轻20.27毫米（95%CI -24.50至-16.04，P<0.001；I²=0%）。LLLT似乎在6小时、3天和7天时也能减轻疼痛。其他评估比较的结果尚无定论，因为证据质量非常低。在五项研究（272名参与者）中评估了振动装置，其中四项研究存在高偏倚风险，一项研究偏倚风险不明确。在三项研究（181名参与者）中评估了咀嚼辅助物（口香糖或咬合片）；两项研究存在高偏倚风险，一项研究偏倚风险不明确。在一项偏倚风险不明确的试验（36名参与者）中评估了脑波音乐和认知行为疗法。在一项存在高偏倚风险的研究中评估了治疗后短信（39名参与者）。在任何研究中均未测量不良反应。
总体而言，结果尚无定论。尽管现有证据表明激光照射可能有助于在短期内减轻正畸治疗期间的疼痛，但该证据质量较低，因此我们不能依赖这些结果。其他非药物干预措施的证据质量要么非常低，要么完全缺乏。需要进一步的前瞻性研究来解决一系列非药物干预措施管理正畸疼痛有效性方面可靠证据不足的问题。未来的研究应采用延长随访，并应测量成本和可能的危害。
