Background
Summary of Council Decision:
Three issues were investigated, all of which were Upheld.
Ad description
The website for IGDP dental practise www.igdp.co.uk, seen on 23 April 2016, included a web page entitled Fastbraces. Text on that page stated “New Technology Fastbraces … Could be 20 weeks… Immediate root movement... Less resorption statistically... Pain reduced statistically … What are the advantages of Fastbraces? Fast! Treatment times range from 3 months to about a year[.] Fastbraces Technology typically works with just one orthodontic wire from start to finish, whereas old braces usually require a series of wires and tightening procedures… Now treatment time can be measured in months instead of years … Patients oftentimes experience less discomfort … Pain reduction... Advances in technology are rapidly changing the way braces straighten teeth, the length of time it takes, the cost, and the comfort level. Research has shown lower sensitivity from greater pain reduction with the bracket system of Fastbraces Technology”.
Issue
The complainant, an orthodontist, challenged whether the following claims for Fastbraces in relation to other orthodontic braces were misleading and could be substantiated:
1. “Less [root] resorption statistically”;
2. “Pain reduced statistically … Pain reduction … greater pain reduction”; and
3. “Fast”.
Response
1. 2. & 3. IGDP Ltd said that Fastbraces had been the subject of a great deal of research over almost 30 years. They said it was acknowledged that there were difficulties associated with research into orthodontic practises which often concluded that the existing evidence was poor or unreliable. Therefore, evidence limited to clinical trials presented an incomplete picture. When substantiation was considered, they did not believe that it was sufficient to rely on independent clinical trials alone, but that a practitioner’s clinical experience should be considered. IGDP said the claims that Fastbraces were faster than other orthodontic braces and led to a lower instance of root resorption were based on their own clinical experience, research, training and patient feedback. Fastbraces achieved results through low force and friction, and its design allowed for simultaneous realignment of tooth crowns and roots.
IGDP noted that the ad clearly stated that a consumer ‘could’ be a candidate for treatment with Fastbraces. Therefore, consumers would not be led to believe that Fastbraces were a definitive treatment for orthodontic issues.
IGDP provided a range of documents, for example, a tabloid newspaper article, a spreadsheet that listed Fastbraces treatment time, research summaries, a systematic review, papers on the management of various orthodontic issues, individual case reports, a list of articles, in vitro testing and one research paper, which they said substantiated the claims made for Fastbraces.
Furthermore, they said that Fastbraces had a US patent and were also classed as a Class IIa medical device, that they had been in use for around 30 years and available in 40 countries.
Assessment
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 “Pain reduced statistically … Fast … Pain reduction [and] greater pain reduction” to mean that Fastbraces would realign teeth with less pain and in less time compared with other orthodontic braces. Furthermore, while consumers were unlikely to be familiar with the term “tooth resorption” (an unwanted side-effect of some orthodontic treatments which manifested as pain, swelling and/or loose teeth), we considered they could easily research the term, and nonetheless, from the context, were likely to (correctly) believe it was a negative side-effect of braces which was reduced with Fastbraces.
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 influenced 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. While we noted that the ad stated that consumers ‘could’ be a candidate for Fastbraces and that they “typically work[s] with just one orthodontic wire from start to finish”, and therefore not all patients would be suitable for treatment or that in some cases one wire would be sufficient, we did not consider that that relieved IGDP of their responsibility to hold evidence to substantiate the various claims made, particularly for those who would be suitable for treatment.
We noted IGDP’s assertion that there were difficulties associated with research into orthodontic practises, therefore substantiation should not be based on independent clinical trials alone. However, we considered 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 various documents provided by IGDP. We considered that the document summaries and list of research papers provided were not adequate to substantiate the claims made because it was not possible to assess those materials in full. In addition, because one of the papers was based on in vitro testing and therefore not conducted on humans, we also did not consider it to be applicable to the claims made. We noted the individual case reports provided. In the absence, however, of any accompanying body of comparative evidence, we did not consider that, in isolation, the reports were sufficient to demonstrate the efficacy of the treatment compared with traditional braces. The full research paper provided addressed resorption, but we noted that it contained a significant methodological flaw – i.e.,, the participants were not randomised. Furthermore, the additional papers provided did not directly address the claims made, or compare Fastbraces with other orthodontic braces. Therefore, we considered that IGDP had not: provided a full body of evidence that took into consideration the differences in the issues to be resolved; compared Fastbraces with other types of braces; and, addressed pain, speed and the various issues associated with tooth resorption.
Given how we considered consumers were likely to interpret the claims and because IGDP had not provided adequate evidence comparing the efficacy of Fastbraces to other types of braces, we concluded the claims had not been substantiated and were misleading.
The ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
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.
(Substantiation),
3.11
3.11
Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.
(Exaggeration),
3.33
3.33
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
12.1
12.1
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).
Action
The ad must not appear again in its current form. We told IGDP Ltd not to claim that Fastbraces were faster, caused less pain and less root resorption compared to other, similar orthodontic treatments in the absence of adequate substantiation.
