Almaha Alhussain, Martyn T Cobourne, Nikolaos Pandis, Jadbinder Seehra
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引用次数: 0
Abstract
Background: The advertisement and adoption of untested orthodontic products is common. This study aimed to provide an update regarding the prevalence of clinical trials in orthodontics evaluating commercially marketed products. Associations between marketed/non-marketed products and study characteristics such as direction of effect, declaration of conflict of interest and industry sponsorship were evaluated. In addition, within the marketed products associations between direction of effect and study characteristics were explored.
Material and methods: Electronic searching of a single database (Medline via PubMed) was undertaken to identify Randomized controlled trials (RCTs) published over a 5-year period (1st January 2017 to 31st December 2021). Descriptive statistics and associations between trial characteristics were explored.
Results: 196 RCTs were analysed. RCTs were frequently published in Angle Orthodontist (18.4%), American Journal of Orthodontics and Dentofacial Orthopedics (14.8%) and European Journal of Orthodontics (13.3%). 65.3% (128/196) of trials assessed marketed products after their introduction. The majority of trials assessed interventions to improve treatment efficiency (33.7%). Growth modification appliances were typically analysed in non-marketed compared to marketed products. An association between the type of product (marketed vs non-marketed) and both the declaration of conflict of interest and industry sponsorship was detected. For individual RCTs assessing marketed products either a positive effect (45.3%) or equivalence between interventions or between intervention and untreated control (47.7%) was evident. In 27% of these trials either no conflict of interest or industry funding was not clearly declared. Within the marketed products, no association between the direction of the effect and conflict of interest or funding was detected.
Conclusions: The analysis of marketed orthodontic products after their introduction is still common practice. To reduce research waste, collaboration prior to the licensing and marketing of orthodontic products between researchers, industry and manufacturers is recommended.
背景：未经测试的正畸产品的广告和采用是常见的。这项研究旨在提供有关口腔正畸临床试验流行率的最新情况，以评估商业营销产品。对已上市/未上市产品与研究特征（如效果方向、利益冲突声明和行业赞助）之间的关联进行了评估。此外，在已上市的产品中，还探讨了效果方向和研究特征之间的关联。材料和方法：对单个数据库（Medline via PubMed）进行电子搜索，以确定5年内（2017年1月1日至2021年12月31日）发表的随机对照试验（RCT）。研究了描述性统计和试验特征之间的相关性。结果：对196例随机对照试验进行了分析。随机对照试验经常发表在《Angle Orthodontist》（18.4%）、《American Journal of Orthodontics and Dentofacial Orthopedics》（14.8%）和《European Journal of Orthodontics》（13.3%）上。65.3%（128/196）的试验在上市产品推出后对其进行了评估。大多数试验评估了提高治疗效率的干预措施（33.7%）。生长调节剂通常在非上市产品和上市产品中进行分析。检测到产品类型（已上市与未上市）与利益冲突声明和行业赞助之间存在关联。对于评估上市产品的个体随机对照试验，干预措施之间或干预与未治疗对照之间的积极效果（45.3%）或等效性（47.7%）是明显的。在这些试验中，27%的试验要么没有利益冲突，要么没有明确宣布行业资金。在已上市的产品中，未发现效果方向与利益冲突或资金冲突之间的关联。结论：市场上销售的正畸产品在推出后的分析仍然是常见的做法。为了减少研究浪费，建议研究人员、行业和制造商在正畸产品的许可和营销之前进行合作。
期刊介绍：
Progress in Orthodontics is a fully open access, international journal owned by the Italian Society of Orthodontics and published under the brand SpringerOpen. The Society is currently covering all publication costs so there are no article processing charges for authors.
It is a premier journal of international scope that fosters orthodontic research, including both basic research and development of innovative clinical techniques, with an emphasis on the following areas:
• Mechanisms to improve orthodontics
• Clinical studies and control animal studies
• Orthodontics and genetics, genomics
• Temporomandibular joint (TMJ) control clinical trials
• Efficacy of orthodontic appliances and animal models
• Systematic reviews and meta analyses
• Mechanisms to speed orthodontic treatment
Progress in Orthodontics will consider for publication only meritorious and original contributions. These may be:
• Original articles reporting the findings of clinical trials, clinically relevant basic scientific investigations, or novel therapeutic or diagnostic systems
• Review articles on current topics
• Articles on novel techniques and clinical tools
• Articles of contemporary interest
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