Background

Ad description

A website, www.acceledent.co.uk, promoting an orthodontic device, seen in July 2017, featured text on the “How it works” page that stated, “Accelerated Treatment When used with braces or aligners, AcceleDent is clinically proven to move teeth up Hopefully [sic] to 50% faster1 … Reduced Pain and Discomfort AcceleDent is also clinically proven to reduce the pain and discomfort associated with braces and aligners by up to 71%1”. The claims appeared next to boxes featuring text that stated “UP TO 50% FASTER” and “UP TO 71% LESS PAIN”. At the bottom of the page text stated “References: 1. Data on file”.

Issue

The complainant, an NHS orthodontist, challenged whether the following claims were misleading and could be substantiated:

1. “When used with braces or aligners, AcceleDent is clinically proven to move teeth up Hopefully [sic] to 50% faster”; and

2. “AcceleDent is also clinically proven to reduce the pain and discomfort associated with braces and aligners by up to 71%”.

Response

OrthoAccel Technologies Inc t/a AcceleDent provided a certificate from the relevant Notified Body showing that the device met the requirements of Annex V of Council Directive 93/42/EEC concerning medical devices and that the product was a Class IIa medical device.

1. AcceleDent referred to two clinical studies which they believed supported the claim “When used with braces or aligners, AcceleDent is clinically proven to move teeth up Hopefully [sic] to 50% faster”. Furthermore, they provided 11 cases involving patients who had used the advertised device. They explained that those patients were not part of a clinical study, nor were they tests that they had conducted, but were results orthodontists had obtained by using AcceleDent on their patients, which they provided to AcceleDent to use to promote the device.

AcceleDent stated that it would be incorrect for consumers to interpret the claim to mean that the advertised device would decrease the length of treatment time by 50%. However, AcceleDent believed they had supported such an interpretation with the 11 patient cases which they had provided. They stated that there was a significant reduction in treatment time for each patient and in some cases, was reduced up to and beyond 50%, based on the doctor’s projected treatment time versus the actual treatment time.

AcceleDent stated that the clinical studies they provided, which were the basis for the claim, did not measure the overall length of treatment time, but reported an increase in rate of tooth movement, which they believed was made clear in the claim. Furthermore, they stated that the studies had complied with the recommendations for reporting randomised trials set by a reputable organisation.

AcceleDent referred to the first clinical study and stated that the intra- and inter-rater errors could not be recorded because of the measuring technique that was used (i.e. measuring a distance tooth travelled directly in the patient’s mouth). To determine the errors of those in vivo measurements, AcceleDent said it would be necessary that during a single patient visit, the same rater would need to re-measure the space that they had just measured to record any tooth movement. AcceleDent believed that such a methodology of measurement would be open to a possibility of a potential bias of the rater. AcceleDent said that a reliable error measurement required a time period between the measurements (a week or two) and blinding of the subject’s identity, which they believed was not possible in a clinic environment where the rater saw the patient’s face. Acceledent therefore believed that measuring errors directly in a patient’s mouth was not a reliable and unbiased approach and instead, measuring errors on a typodont was the most accurate and the only possible way to accurately assess the differences between the raters. Furthermore, the statistics showed that there was no significant intra- and inter-rater variability between the raters’ measurements.

2. AcceleDent referred to a clinical study that appeared on their website, which they believed supported the claim “AcceleDent is also clinically proven to reduce the pain and discomfort associated with braces and aligners by up to 71%”.

AcceleDent stated that the claim was based primarily on the results from the clinical study they had provided and on other published studies using various modalities of vibrations during orthodontic treatment. They believed that while the study they provided did not include a placebo control group, that limitation should not be used to completely discredit the claim about reduced pain and discomfort. Furthermore, they stated that the study had complied with the recommendations for reporting randomised trials set by a reputable organisation.

Assessment

The ASA understood that AcceleDent held a Class IIa medical device certification, and while medical devices were regulated by designated Notified Bodies, marketing communications in the UK were assessed by the ASA against the Advertising Codes.

1. Upheld

The ASA considered that consumers would interpret the claim “When used with braces or aligners, AcceleDent is clinically proven to move teeth up Hopefully [sic] to 50% faster” to mean that if the advertised product was used in conjunction with braces/aligners, it could make the process of straightening teeth up to 50% faster.

We referred to the 11 cases AcceleDent provided, which included details such as the patient’s name, gender, age and diagnosis given. Each case reported that the actual treatment time for all patients was less than the projected treatment time. However, no information regarding how the device, along with the orthodontic treatment that was administered to each individual patient, was provided. Furthermore, we considered that such information on its own was not adequate to support the claim and that further documentary evidence, in the form of human clinical trials was required.

We reviewed the first US clinical study AcceleDent provided and understood that its aim was to determine whether vibration produced by the AcceleDent device increased the rate of tooth movement in patients with fixed orthodontic appliances.

The study involved 45 patients and was a randomised, controlled, double-blind, parallel group clinical trial. Subjects were randomly allocated to either the treatment group receiving the AcceleDent device or the control group that used a non-vibrating appliance. A third-party vendor provided a computer-generated randomisation schedule to ensure that participants were equally distributed between the groups. The device was given to the assigned treatment group by an independent party and both the investigators and the subjects remained blinded to treatment. All subjects were treated by orthodontic residents under supervision of an investigator/faculty.

However, we understood that an analysis of the measurement error relating to tooth movement was carried out on a model of the oral cavity (a typodont) and not on the actual patients. The study stated that direct measurement of space closure in patients’ mouths prevented the analysis of ‘intra-rater error’ to be conducted at the same time, but did not provide any explanation of why that was the case, including whether that was the consensus in the dental field. We understood that ‘intra-rater’ was a type of reliability assessment in which the same assessment was completed by the same rater on two or more occasions. The different ratings would then be compared to measure the extent to which the variables in a study were associated with one another.

The ‘intra-rater’ and ‘inter-rater’ reliability used in the study was therefore tested by making measurements on 12 different quadrants of typodonts with mounted mini screws and bonded brackets. However, the study did not provide any further details regarding how that was carried out and why it was considered to be a robust way of measuring error relating to tooth movement. We therefore considered that was a poor approximation of measuring error to the clinical situation and affected the robustness of the study’s results, which reported a significant increase in the rate of orthodontic tooth movement for patients in the treatment group.

In relation to the second US clinical study AcceleDent provided, we took independent expert advice. We understood that the study’s aim was to also determine whether vibration produced by the AcceleDent device increased the rate of tooth movement in patients with fixed orthodontic appliances.

The parallel group clinical study enrolled 45 participants and was randomised, controlled and double-blinded.

We noted that all participants were required to have extractions of at least one upper bicuspid (a tooth with two cusps) creating a space of at least 3 mm prior to space closure before commencing their orthodontic treatment. Furthermore, a similar number of participants with “canine retraction” and “en masse” retraction (retraction of all six anterior teeth) were included in each treatment group. That suggested that within both treatment groups participants did not receive the same number of bicuspid extractions and that not all had a canine and en masse retraction. We considered that led to subdivisions of both groups where the orthodontic treatment and considerations would vary based on the different number and type of extractions performed on the participants.

The study stated that to minimise the number of additional appointments required for patients compared to the routine orthodontic follow-up schedule, assessments were to be made during regularly scheduled subject visits for brace adjustments, rather than during visits scheduled specifically to collect device information. This was deemed to be sufficient, based on the standard frequency and interval between routine orthodontic appointments. However, we noted that the assessments were not required to occur precisely at the times as originally designated. In that respect, we considered the study’s design could have varied for each individual participant, specifically that there may have been discrepancies in the period of time each participant had their assessment carried out along with the necessary brace adjustments.

We noted that the study did not refer to a measurement of error when determining how accurate the investigator was at measuring extraction spaces. We considered that such action would have made the data reliable in order to establish the validity of the study’s objective.

The study was initially designed to remove any participants were found to have loose temporary anchorage devices (TADs) during the course of the study. However, that no longer became the case and such patients could continue to participate in the study, but with a new set of baseline measurements for the purposes of assessing study endpoints. Such a change was made because TADs were routinely replaced and the participants continued with their orthodontic treatment. However, we considered assessing the study endpoint that was partially based on baseline measurements that were taken after the treatment had started in both groups, was not an accurate method to objectively determine whether the AcceleDent device increased the rate of tooth movement in patients with fixed orthodontic appliances.

Because AcceleDent had not provided adequate evidence to support the claim “When used with braces or aligners, AcceleDent is clinically proven to move teeth up Hopefully [sic] to 50% faster”, we concluded that it had not been substantiated and was misleading.

On that point the claim 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) 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.

2. Upheld

We considered that consumers would interpret the claim “AcceleDent is also clinically proven to reduce the pain and discomfort associated with braces and aligners by up to 71%” to mean that if used in conjunction with braces/aligners, it could reduce the associated pain by up to 71%.

We reviewed the clinical study AcceleDent had referenced to support the claim and we understood that its aim was to determine whether the AcceleDent device reduced orthodontic pain during the first four months of orthodontic treatment.

The study enrolled a sample of 70 adult and child participants and was a randomised, controlled and parallel group clinical trial that was conducted over a four-month period. Patients were assigned to comparison groups using a block allocation sequence and randomisation was concealed from the investigators. Patients were randomised in blocks of ten, with five patients being allocated to each arm of the trial until all 70 patients were randomised. For participant allocation, a computer-generated list of random numbers was used.

Patients in the control and treatment groups wore braces and only the latter used the AcceleDent device. The participants in the study recorded their pain using visual analogue scales for the first seven days following adjustment and then weekly for the remainder of the trial. Participants were all asked not to take painkillers.

We noted that the control group was not given a placebo. Given the study’s objective to assess pain relief, we considered that was an important variable that could affect the study’s results. We understood that placebos were used in such studies in order to find out whether the treatment had a genuine effect or whether the effects it produced might be related to psychological processes that were commonly called the placebo effect.

We noted that the study stated that it could not have used a “sham” device because that may have influenced the reporting of pain. However, we considered that this was the very purpose of having a placebo.

Because the trial was not placebo-controlled, we considered AcceleDent had not provided adequate evidence to support the claim “AcceleDent is also clinically proven to reduce the pain and discomfort associated with braces and aligners by up to 71%”. We concluded that the claim had not been substantiated and was misleading.

On that point the claim 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) 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 OrthoAccel Technologies Inc not to make claims that their AcceleDent device could move teeth faster and reduce pain for brace wearers unless they held adequate evidence to support such claims.

CAP Code (Edition 12)

12.1     3.1     3.7    

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