A web page describing Damon dental braces, seen on www.15dental.com in December 2016, stated “Three key components, which when used together, deliver faster treatment, fewer appointments, greater comfort, and consistent high-quality results: 1. Damon passive self-ligating braces that eliminate the need for elastic or metal ‘ties’. With Damon tie-less braces you can experience treatment without tightening. 2. Light high-technology shape-memory wires that move teeth faster and require fewer adjustments. 3. A new clinically proven treatment approach that aligns your teeth and enhances your facial aesthetics-usually without extractions or rapid palatal expanders. Traditional braces … are tied in with elastics, which cause friction and pressure, making treatment slower and less comfortable. Damon braces use a slide mechanism to hold the wire, which allows teeth to move more freely, quickly and comfortably”.
The complainant, an NHS orthodontist, challenged whether the ad misleadingly implied the Damon brace system involved a faster process and one that was less painful than traditional braces.
Ormco Corporation, the manufacturer of Damon braces, replied on behalf of 15 Dental. They stated that Damon braces had been on the market for over 20 years, and they believed that their research confirmed that individuals wearing Damon braces experienced less “chairside time” (time spent in an appointment with their orthodontist) and experienced less pain compared with those wearing traditional braces. They had received a large volume of feedback from orthodontists around the world who stated that they used Damon braces because they provided quicker and less painful treatment than traditional braces.
Ormco stated that there were limitations on their ability to obtain meaningful evidence from randomised controlled clinical trials due to the nature of orthodontic treatments. They said that the majority of the evidence base in orthodontics was in vitro. They believed that a combination of in vitro and in vivo studies constituted a robust evidence base in which multiple methods complemented each other and overcame the intrinsic biases of single-method studies. Furthermore, they were of the view that claims relating to the application of braces would be seen as performance claims rather than health claims, and therefore should not be subject to the same standard of evidence under the CAP Code.
That notwithstanding, Ormco submitted a number of documents which they said supported the claims. These included clinical studies, articles, a discussion document, a survey of orthodontic practitioners and Masters theses.
The web page stated “Three key components … deliver faster treatment, fewer appointments, greater comfort”, “light high-technology shape-memory wires move teeth faster and require fewer adjustments” and “Traditional braces … are tied in with elastics, which cause friction and pressure, making treatment slower and less comfortable. Damon braces use a slide to hold the wire, which allows teeth to move more freely, quickly and comfortably”. The ASA considered that consumers were likely to understand these claims to mean that Damon braces provided faster and less painful treatment than traditional braces.
We noted Ormco’s assertion that there were difficulties associated with research into orthodontic practices and that therefore substantiation should not be based on clinical trials alone. We considered, however, that a body of evidence should include at least one independently and well-designed randomised controlled trial in order to ensure conclusions were unbiased and objective.
We reviewed the evidence submitted by Ormco. Several of the documents were unpublished Masters theses, or commercial surveys, which were not peer-reviewed. Four of the studies were conducted using models of the mouth rather than human subjects. While we acknowledged that in vitro studies could form an important part of orthodontic research and development, we did not consider that they were sufficient to support claims about the comparative performance of the braces in humans in the absence of adequate clinical trials.
Ormco provided a number of clinical trials comparing the effect of Damon and/or other self-ligating braces with traditional braces. However, many of these studies measured surrogate markers, such as microbial count or frictional forces, rather than measuring pain or rate of tooth movement directly as referenced by the claims in the ad. While several of the studies reported faster treatment times or reduced pain for participants using self-ligating braces compared to those using conventional braces, they all exhibited methodological issues. These included potential sample selection bias (in that participants were selected retrospectively from among the authors’ patients), per-protocol analysis of comparative results, conclusions drawn from one population subgroup, reporting errors and a lack of randomisation in treatment allocation. While single-blinding would be appropriate in this instance, none of the trials were blinded.
Given the above, we considered that the evidence provided by Ormco was not adequate to demonstrate that Damon braces provided faster and less painful treatment than traditional braces. We concluded that the claims had not been substantiated and were therefore misleading.
The ad breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
Marketing communications that include a comparison with an identifiable competitor must not mislead, or be likely to mislead, the consumer about either the advertised product or the competing product.
(Comparisons with identifiable competitors) and
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease. (Medicines, medical devices, health-related products and beauty products).
The ad must not appear again in its current form. We told 15 Dental not to claim that Damon braces provided faster or less painful treatment than traditional braces in the absence of sufficient evidence to substantiate this.