Clinical evaluation of marketed and non-marketed orthodontic products: are researchers now ahead of the times? A meta-epidemiological study.

Oct 23, 2023

Contributors: Almaha Alhussain,Martyn T Cobourne,Nikolaos Pandis,Jadbinder Seehra

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.
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.
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.
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.

© 2023. Italian Society of Orthodontics.

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ABOUT THE CONTRIBUTORS

Almaha Alhussain,Martyn T Cobourne,Nikolaos Pandis,Jadbinder Seehra
Almaha Alhussain

Department of Orthodontics, Faculty of Dentistry, Oral & Craniofacial Sciences, King’s College London, Floor 21, Guy’s Hospital, Guy’s and St Thomas NHS Foundation Trust, London, SE1 9RT, UK.

Martyn T Cobourne

Department of Orthodontics, Faculty of Dentistry, Oral & Craniofacial Sciences, King’s College London, Floor 21, Guy’s Hospital, Guy’s and St Thomas NHS Foundation Trust, London, SE1 9RT, UK.

Centre for Craniofacial Development and Regeneration, Faculty of Dentistry, Oral & Craniofacial Sciences, King’s College London, Floor 27, Guy’s Hospital, Guy’s and St Thomas NHS Foundation Trust, London, SE1 9RT, UK.

Nikolaos Pandis

Department of Orthodontics and Dentofacial Orthopedics, Dental School/Medical Faculty, University of Bern, Bern, Switzerland.

Jadbinder Seehra

Department of Orthodontics, Faculty of Dentistry, Oral & Craniofacial Sciences, King’s College London, Floor 21, Guy’s Hospital, Guy’s and St Thomas NHS Foundation Trust, London, SE1 9RT, UK. jadbinderpal.seehra@kcl.ac.uk.

Centre for Craniofacial Development and Regeneration, Faculty of Dentistry, Oral & Craniofacial Sciences, King’s College London, Floor 27, Guy’s Hospital, Guy’s and St Thomas NHS Foundation Trust, London, SE1 9RT, UK. jadbinderpal.seehra@kcl.ac.uk.