Are commercially marketed orthodontic products tested before promotion and release?
Most orthodontic developments are commercially driven. This includes self-ligated brackets, methods to speed up tooth movement, temporary anchorage devices and clear aligners. While this evolution may have improved our speciality. Unfortunately, it seems that products are released onto the market without being adequately tested in trials. Importantly, when these trials are done, they reveal that many of the claims made for the treatment are false. The best examples of this are self-ligating brackets, class II correctors and orthodontic vibrators. However, we do not know how many products are promoted without testing. This new paper provides us with this information, but it does not make comfortable reading.
A team from London, UK, did this study. Progress in Orthodontics published the paper. It is open access, so you can read it yourself without being a member of an orthodontic society.
Almaha Alhussain, Martyn T. Cobourne,Nikolaos Pandis and Jadbinder Seehra
Progress in Orthodontics: Advance access online. https://doi.org/10.1186/s40510-023-00487-y
I want to declare a conflict as I know most of the members of this team well, and I have worked with them in the past.
What did they ask?
They did the study to answer this question.
“What is the prevalence of clinical trials in orthodontics evaluating commercially marketed and non-marketed products”?
“Is there a presence of associations between the direction of the results of these trials in declaration of conflicts of interest and industry sponsorship”?
What did they do?
They did a meta-epidemiological study of orthodontic RCTs from 1st January 2017 to 31st December 2017.
I did not know what a meta-epidemiological study was, so I looked it up. I found this definition.
“Meta-epidemiological studies adopt a systematic review or meta-analysis approach to examine the impact of certain characteristics of clinical studies on the observed effect. The unit of analysis is the study not the patient”.
In other words, this looks at the characteristics of the studies to see if they influence the results and conclusions. This seems sensible to me.
They followed standard systematic review methods of electronic data search for papers, filtering the publications, and data extraction. They extracted a large amount of data from the papers. I thought that, of these, the most important were a declaration of conflicts of interest, source of funding, type of intervention, and direction of the intervention effect.
What did they find?
They identified 196 RCTs. The highest number of trials were published in the Angle Orthodontist (18.4%), AJO-DDO (14.8%), and EJO (13.3%).
- 65.3% of the trials assessed marketed products after their introduction.
- 44.9% found a positive effect of the intervention
- 47.4% found no difference.
- In 66.3%, no conflict of interest was declared. However, in 26%, this was not clear.
- For RCTs assessing marketed products, 45.3% reported a positive effect, and 47% reported no effect or equivalence between interventions.
- For marketed products, there was no association between industry funding and direction of effect.
- There was no association between declared conflict of interest and treatment effect.
What did I think?
This paper looked at a meaningful and relevant subject. The team used the correct methodology to answer the study question. The article was written clearly and was easy to understand.
The authors described a large amount of data; it is worth getting a copy of the paper and looking at it closely. I learned a lot from this study and looked at how the findings impact our knowledge of new innovations.
Importantly, it appears that most published trials assessed the effect of the innovation after its introduction onto the market. This emphasises that orthodontic companies do not carry out research into their products. They and their KOLs then make unfounded claims for their effects. I have written about these many times before. However, this is so important that it is worth repeating. The bottom line here is that we should not believe any of the claims that are made in the absence of research. This paper nicely illustrates the extent of this problem.
Secondly, when studies were done, while it was good to see that 44% found a positive effect of the intervention, it was disappointing that in 47% of trials, there was no evidence of an intervention. When I think back, these were likely to be the trials of self-ligation and some methods to speed up treatment. Again, this represents the unethical approach taken by some companies.
The study team also pointed out that researchers should be involved in the development process if we want to reduce research waste and ensure that products are correctly assessed.
We also need to consider the author’s conflict of interest declaration. This is a crucial step in the publication process. Again, it was disappointing that apparent conflicts were not declared in 26% of studies. I found this surprising because I thought that as part of the submission process of a paper, it was essential for authors to declare conflicts. As a result, I cannot understand why the journals are not insisting on this step.
The good news is that the direction of effect was not related to whether the trial was industry-funded. This means that those companies that funded trials did not influence the results. This represents a good ethical collaboration between industry and researchers.
This paper got me thinking, and I was disappointed to find a limited relationship between the orthodontic industry and clinical researchers. The companies appear to ignore the important step of researching their products. Instead, they introduce them onto the market with the help of their KOLs. This is a sorry state.
Emeritus Professor of Orthodontics, University of Manchester, UK.