Abstract
BackgroundThe 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.MethodsElectronic 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.ResultsEighty-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.ConclusionsAlmost 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.
Highlights
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
While the relative frequency of clinical trials has increased in orthodontics, it is known that systematic reviews comparing the effectiveness of interventions almost invariably cite a lack of primary studies, those of high quality, with a mean of just four clinical trials included in orthodontic meta-analyses [5]
84 randomized controlled trials (RCTs) published in 23 scientific journals were included in this study (Fig. 1)
Summary
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. In 2015, for example, there were 89 dental journals and Seehra et al Progress in Orthodontics (2017) 18:14 eight orthodontic journals with an impact factor, with 596 citable papers published in these orthodontic journals alone, and the past decade has seen significant increases in the quantity of systematic reviews in orthodontics with 157 published between 2000 and 2014, the yield from many of these has been limited [5] Within this evidence-based approach, clinical trials which incorporate random allocation of participants to treatment groups are considered optimal to allow evaluation of the comparative effectiveness of interventions. Meta-epidemiological research in orthodontics has indicated that inadequate randomization procedures, blinding and handling of missing data are pervasive within clinical trials [7]
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