Sivaramakrishnan Gowri, Sridharan Kannan
Department of Oral Health, College of Medicine, Nursing and Health Sciences, Fiji National University, Hoodless House, Brown Street, Suva, Fiji.
Department of Pharmacology, Fiji National University, Extension Street, Suva, Fiji.
J Evid Based Dent Pract. 2016 Jun;16(2):90-5. doi: 10.1016/j.jebdp.2016.03.002. Epub 2016 Mar 26.
Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged.
Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies.
A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded.
The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be laid down on the quality of trials being conducted in order to provide justice in the name of EBP.
临床试验是循证医学实践（EBP）的支柱，近来循证医学被视为现有治疗策略的最佳来源。临床试验注册库充当临床试验的数据库。就牙科领域而言，缺乏关于临床试验数量及其质量的具体数据。因此，开展了本研究。
纳入在世界卫生组织国际临床试验注册平台（http://apps.who.int/trialsearch/AdvSearch.aspx）注册的牙科专业临床试验。从收集到的试验中评估的详细信息包括：申办者类型；健康状况；招募状态；研究设计；随机化、随机化方法和分配隐藏；单中心或多中心；回顾性或前瞻性注册；以及完成研究的发表状态。
共识别出197项试验。试验数量最多的是美国（n = 30）和英国（n = 38）。76项试验在ClinicalTrials.gov注册，54项来自国际临床试验报告标准，澳大利亚和新西兰试验注册库以及伊朗临床试验注册库各有13项，德国临床试验注册库有10项，巴西临床试验注册库和荷兰试验注册库各有8项，日本临床试验注册库有7项，印度临床试验注册库有6项，香港临床试验注册库有2项。共有78.7%的研究由研究者发起，64%已完成，3%已终止。近五分之四（81.7%）的注册试验为干预性研究，其中大多数（94.4%）为随机试验，63.2%为开放标签试验，20.4%采用单盲技术，16.4%为双盲试验。
已注意到牙科临床试验的数量、方法和特征不佳，特别是在多中心开展、采用盲法以及随机化和分配隐藏方法方面。必须更加重视所开展试验的质量，以便以循证医学的名义实现公平。
