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 (Misleading advertising), 3.7 (Substantiation), 3.11 (Exaggeration), 3.33 (Comparisons with identifiable competitors) and 12.1 (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.

Submitted by Nicky Stanford, Liverpool, UK

https://www.asa.org.uk/rulings/igdp-ltd-a16-348854.html

Accessed August 31, 2017

The Advertising Standards Authority (ASA) is the UK’s independent regulator of advertising across all media. The ASA applies the Advertising Codes, which are written by the Committees of Advertising Practice (CAP).

Copyright © 2017 ASA and CAP. Reprinted with permission, Advertising Standards Authority UK.

AD Description

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”.

Issue

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.

Response

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.

Assessment

Upheld

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

3.1 (Misleading advertising), 3.33 (Substantiation), 3.7 (Comparisons with identifiable competitors) and 12.1 (Medicines, medical devices, health-related products and beauty products).

Action

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.

Submitted by Nicky Stanford, Liverpool https://www.asa.org.uk/rulings/15-dental-a16-365575.html

Accessed October 4, 2017

The Advertising Standards Authority (ASA) is the UK’s independent regulator of advertising across all media. The ASA applies the Advertising Codes, which are written by the Committees of Advertising Practice (CAP).

Copyright © 2017 ASA and CAP. Reprinted with permission, Advertising Standards Authority UK.