Clinical evaluation of marketed orthodontic products: are researchers behind the times? A meta-epidemiological study.

BACKGROUND: The role of marketing and industry in the treatment decisions of orthodontists has received increasing attention in recent years with clinical research typically undertaken subsequent to established use of these devices and often failing to confirm the promise of manufacturers' claims. This meta-epidemiological study was undertaken to assess the proportion of clinical trials in orthodontics evaluating commercially marketed products and to evaluate the direction of the results of these studies. METHODS: Electronic searching was undertaken to identify randomized controlled trials (RCTs) published over a 5-year period (1 January 2012 to 31 December 2016). Data obtained included the type of marketed intervention, direction of effect and declaration of both industry sponsorship and conflict of interest. RESULTS: Eighty-four RCTs published in 23 scientific journals were included with the highest percentage in the American Journal of Dentofacial Orthopedics (AJO-DO) (23.8%), followed by the European Journal of Orthodontics (EJO) (14.3%), Journal of Orthodontics (JO) (10.7%) and Angle Orthodontist (AO) (10.7%). Overall, 45% (38/84) of clinical trials assessed involved analysis of marketed products after their introduction. Interventions to improve oral health or circumvent the risk of iatrogenic damage, such as white spot lesions, were most commonly assessed (15.8%), with the relative merits of non-surgical adjuncts (14.1%) and other orthodontic auxiliaries (13.1%) also frequently evaluated. In 44% of RCTs, a positive effect of the marketed intervention was not reported. Industry sponsorship of the research was declared in 9.5% RCTs. No significant associations between the direction of the effect and both declaration of industry sponsorship (p = 0.56) and conflict of interest (p = 0.96) were detected. Moreover, for marketed and non-marketed products, no significant associations for both declaration of industry sponsorship (p = 0.44) and conflict of interest (p = 0.28) were found. CONCLUSIONS: Almost half of orthodontic clinical trials over the past 5 years involve analysis of marketed products after their introduction. The results highlight a potential source of waste in orthodontic research emanating from existing approaches to licensing and marketing of orthodontic products

Opening and closure forces of sliding mechanisms of different self-ligating brackets

Self-ligating brackets engage the wire by means of a slide mechanism. Forces that have to be applied to open and close the sliding mechanism of brackets are still unknown. OBJECTIVE: The aim of this study was to measure and compare the opening and closure forces of different self-ligating brackets. MATERIAL AND METHODS: Three different stainless steel self-ligating brackets (Carriere LX, Ortho Organizers; F1000, Leone; Damon Q, Ormco) were tested. For each different bracket, 20 maxillary right central incisors and 20 mandibular right central incisors were used. Opening and closure forces were measured using an Instron Universal Testing Machine. Statistical analysis was performed and ANOVA and Tukey tests were carried out. RESULTS: Opening forces were registered between 1.1 N and 5.6 N, whereas closure forces were recorded between 1.57 N and 4.87 N. Significant differences were detected among the different brackets and between the two prescriptions tested. CONCLUSION: The knowledge of different opening and closure forces of self-ligating brackets can help the orthodontist in the clinical management of these devices