Summary of Council decision:
Three issues were investigated, all of which were Upheld.
The website www.perfectsmile-dental.com, seen on 23 April 2016, included a web page entitled “Research and development”. Text on that page stated “University Research and Testing for safety and performance … Research has confirmed the following key areas … Lower Sensitivity … Research has shown ‘lower sensitivity’ and greater ‘pain reduction’ with the bracket system of Fastbraces Technology … University research in the same journal showed that Fastbraces® Technology presented ‘even less root resorption’ than the traditional systems tested”. A subsequent web page stated “How it works … With safety in mind, Fastbraces Technology was developed to straighten teeth differently - allowing for a fast, safe and affordable solution”.
The complainant, an orthodontist, challenged whether the following claims, in relation to conventional braces, were misleading and could be substantiated:
1. “greater pain reduction”;
2. “less root resorption”; and
1. Perfect Smile Surgery Ltd said that the claim “greater pain reduction” was based on research which included a PhD thesis and one additional study.
2. Perfect Smile Surgery said that research had shown that the longer patients wore braces, the more root resorption occurred. They said that research showed that Fastbraces had less root resorption than traditional brace systems because they moved the roots of teeth towards their final position from the start of the treatment in one stage, which sometimes occurred in weeks.
3. Perfect Smile Surgery said that the Fastbraces mechanism differed to that of traditional braces which meant that treatment was faster. They provided references to journal articles, and a thesis which they said supported their claims. Perfect Smile Surgery also provided three additional articles which they said highlighted the reduction in treatment times with Fastbraces compared with traditional braces.
Along with the information provided, Perfect Smile Surgery provided a list of references to journal articles.
1. 2. & 3. Upheld
The ASA considered that in the context of the web page as a whole, consumers were likely to understand the claims “greater pain reduction” and “fast” to mean that Fastbraces realigned teeth with less pain and in less time. Although the ad had not explicitly stated that Fastbraces had greater pain reduction and were faster in comparison to traditional braces, we considered that consumers would understand that, because they were used to realign teeth, the claims were likely to be interpreted as a comparison with other brace systems. Furthermore, while some consumers were unlikely to be particularly familiar with the term “root resorption”, which we understood was an unwanted side-effect of some orthodontic treatments which manifested as pain, swelling and/ or loose teeth, we considered they would understand that it was a negative side-effect of ‘traditional’ braces which, as claimed, was reduced with Fastbraces and related to the effect on the root of the tooth.
We understood that there could be a number of reasons why consumers would require or request tooth realignment, for example, cosmetic and/ or for clinical reasons. In addition, we understood that the complexity of the problem being treated was likely to influence the length of time treatment was required to satisfactorily realign a person’s teeth. That is, the time from the start of treatment to its conclusion varied from patient to patient, depending on the issue to be addressed. We therefore considered that evidence should be provided which sufficiently addressed those factors.
We reviewed the list of publications, summaries of papers and articles provided by Perfect Smile Surgery and noted that the latter consisted of two case studies and an orthodontic reclassification for misaligned teeth. We did not consider those papers were adequate substantiation for the claims made. Furthermore, because Perfect Smile Surgery had not provided us with full articles related to the comparison between Fastbraces and traditional braces in relation to the claims made, it was not possible to assess whether they were sufficient substantiation.
Therefore, we considered that Perfect Smile Surgery had not provided a sufficient body of evidence that took into consideration the differences in the issues to be resolved which compared Fastbraces with other types of braces, and addressed pain, speed and the various issues associated with tooth resorption. For those reasons, we concluded the claims were misleading and had not been substantiated.
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 must not mislead consumers by exaggerating the capability or performance of a product.
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 Perfect Smile Surgery Ltd not to claim that Fastbraces were faster, caused less pain and less root resorption compared to other, orthodontic treatments in the absence of adequate substantiation.