Pereira Ines Novo, Hassan Haidar
Academic Plastic Surgery, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, E1 2AT, UK.
Evid Based Dent. 2022 May 27. doi: 10.1038/s41432-022-0256-9.
Objective An evidence-based review on the safety and efficacy of botulinum toxin type-A (BoNTA) in orofacial conditions, focusing on the therapeutic applications and role of BoNTA as an adjuvant treatment.Data source and selection Data was collected using PubMed (Medline), Cochrane Library of Systematic Reviews and Cochrane Central Register of Controlled Trials electronic databases. Having satisfied the search parameters, 32 studies for therapeutic applications and 26 for BoNTA as an adjunctive treatment were included. The quality of relevant studies was assessed using the Best Evidence Topics (BETs) Critical Appraisal Tool.Data extraction The highest level of evidence (LOE) behind BoNTA safety and efficacy was for wound healing and scar management in the orofacial surgery context, where BoNTA was presented as an adjunctive modality. Level-I evidence was controversial for temporomandibular disorders and bruxism. However, it showed promising results for painful temporomandibular disorders of myogenic origin refractory to conservative therapies, and to decrease muscle contraction intensity in sleeping bruxism. There was only one level-II study for persistent recurrent aphthous stomatitis. Data showed limited level-III evidence for orofacial pain conditions (temporomandibular joint recurrent dislocation and pain, burning mouth syndrome or atypical odontalgia), oral cancer complications, or as an adjuvant to maxillofacial and orthognathic surgeries. Benefits of BoNTA in prosthodontics had weak level-IV evidence. No evidence was found among the periodontology field.Conclusion There is growing evidence to support the safety and efficacy of BoNTA in the investigated orofacial pathological conditions, with high levels of satisfaction from the patient and clinician perspective. However, there are some inconsistencies and limited high-quality evidence available. Well-designed controlled clinical trials are necessary to evaluate long-term safety, efficacy and cost-effectiveness before BoNTA is widely adopted with irrefutable evidence-based clinical guidelines.
目的 对A型肉毒毒素（BoNTA）在口面部疾病中的安全性和有效性进行循证综述，重点关注BoNTA作为辅助治疗的治疗应用及作用。
数据来源与选择 通过PubMed（Medline）、Cochrane系统评价图书馆和Cochrane对照试验中央注册库电子数据库收集数据。符合检索参数的研究中，纳入了32项关于治疗应用的研究和26项关于BoNTA作为辅助治疗的研究。使用最佳证据主题（BETs）批判性评估工具评估相关研究的质量。
数据提取 BoNTA安全性和有效性背后的最高证据水平（LOE）是在口面部手术背景下的伤口愈合和瘢痕管理方面，其中BoNTA作为一种辅助方式。I级证据在颞下颌关节紊乱和磨牙症方面存在争议。然而，它在保守治疗难治的肌源性疼痛性颞下颌关节紊乱方面显示出有前景的结果，并且在减少睡眠磨牙症中的肌肉收缩强度方面也有效果。关于复发性阿弗他口炎仅有一项II级研究。数据显示在口面部疼痛疾病（颞下颌关节复发性脱位和疼痛、灼口综合征或非典型牙痛）、口腔癌并发症或作为颌面和正颌手术辅助方面的III级证据有限。BoNTA在口腔修复学中的益处有较弱的IV级证据。在牙周病领域未发现证据。
结论 越来越多的证据支持BoNTA在所研究的口面部病理状况中的安全性和有效性，从患者和临床医生的角度来看满意度较高。然而，存在一些不一致性且高质量证据有限。在BoNTA依据无可辩驳的循证临床指南被广泛采用之前，有必要进行精心设计的对照临床试验来评估其长期安全性、有效性和成本效益。
