Key Points
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Raises awareness and categorises the types of over-the-counter (OTC) bruxism splints available on the Internet.
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Highlights the potential pitfalls of patients purchasing an OTC bruxism splint without consulting a dentist.
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Provides advice on the UK regulation of these appliances.
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Stresses that dentists should report suspected adverse events with OTC splints to the relevant authority.
Abstract
Background Some individuals may now be bypassing their dentists for treatment of bruxism. Self-diagnosed, self-adjusted and self-monitored consumers can access over-the-counter (OTC) bruxism splints via the Internet. While some may regard this market as benefiting consumers there are potential pitfalls that need to be highlighted. These include unevidenced claims of efficacy.
Objective To survey OTC bruxism splints available to individuals in the UK via the Internet, categorise their characteristics, and determine any web-based claims or safety warnings. Materials and methods An Internet search was made of OTC bruxism splints available in the UK. The following information was recorded for each OTC splint: the name of the manufacturer, name of the device, its UK price and any claims and safety warnings made either on a major UK retail website or via other UK web retail outlets. In addition, a note was made of any web-based mention of 'CE marking', indicating compliance with the EC Medical Devices Directive's requirements for safety, quality and performance.
Results Safety information is notable for its paucity and is totally lacking on many Internet sites. However, manufacturers are not obliged to display safety information on the Internet, but it must be provided with the product. A search of the MAUDE database showed a number of potentially serious adverse events associated with these splints including choking hazards, tissue damage and occlusal changes. None of the splint designs assure full occlusal coverage.
Conclusions As with any partial coverage appliance, if worn for protracted periods there may be a risk of unwanted tooth movement. Dentists should report or assist patients with reporting suspected adverse events with OTC splints to the relevant competent authority. In the UK this is the Medicines and Healthcare Products Regulatory Agency (MHRA).
Main
R. W. Wassell, L. Verhees, K. Lawrence, S. Davies, F. Lobbezoo British Dental Journal 2014; 216: E24
Editor's summary
I am affected by bruxism and to be honest when I saw the title of this article when it was first submitted to the journal my very first reaction was: 'excellent, I didn't know you could get bruxism splints on the Internet. That's useful.' Oh dear, I hear you say. And I am a trained scientist, editor of a dental journal and should certainly know better. Shame on me!
But, at the end of the day, most patients affected by bruxism will have that very same thought when they discover that these devices are available on the Internet. Unfortunately, the vast majority of them will never have the benefit of reading this BDJ paper, as I did, which shows so plainly why OTC splints available on the Internet are clearly not a sensible idea considering the potentially serious adverse affects.
This paper shows that this important aspect of OTC splints is not currently made clear to Internet consumers because the safety information on these websites is greatly lacking. It also found that none of the splint designs assured the necessary full occlusal coverage.
We can grumble about the fact that the Internet is not appropriately regulated and that inaccurate websites should not be allowed. We can grumble that people should know better and think before they make purchases that could effect their health quite drastically. But it's human nature – when you have something you want to fix, unfortunately we usually seek out a quick fix.
Yet again, it falls to the profession. It will be necessary to be aware of the sale of splints on the Internet and to educate patients as to the associated dangers. This paper highlights that dentists must keep this market in mind, particularly if you find unexplained occlusal changes. It is also important to be aware that patients may not be disclosing this self-treatment.
In the 'Questions and Answers' section associated with this summary, the authors point out that this research came about as a result of a real case in which a patient with an unexplained occlusal change was referred to a UK dental hospital. This was not just some random research project. It is in essence an investigative report – albeit slightly less 'meaty' than those covering US security agency intrigue or world cup bribery scandals.
The full paper can be accessed from the BDJ website ( www.bdj.co.uk ), under 'Research' in the table of contents for Volume 216 issue 11.
Ruth Doherty
Managing Editor
Author questions and answers
1. Why did you undertake this research?
Two years ago a patient with an unexplained occlusal change was referred to a UK dental hospital. His two other dentists were equally mystified by the over-eruption of all his second molars. Persistent questioning revealed a possible factor – he was using an OTC bruxism splint that left these teeth uncovered. The manufacturers emphasised the clinical evidence didn't provide proof of causation and in any case he had worn the splint for longer than recommended. A quick scan of the internet showed a growing number of these products and all of them potentially providing only partial coverage. Hence, the impetus behind the research was the disparity between our mainstream teaching to be cautious when prescribing partial coverage splints and the sudden availability of OTC splints online. We also wanted dentists to be aware that their patients may be using OTC splints but not volunteering this information and to help them report any suspected adverse events.
2. What would you like to do next in this area to follow on from this work?
Hopefully, this work will make dentists aware of OTC bruxism splints. Next we want consumers to know about these appliances so that they can make an informed choice in deciding how their symptoms should be managed. If they decide to buy an OTC splint and experience a suspected adverse event we want them to know how this should be reported. Subject to approval of the Medicines and Healthcare Products Regulatory Agency (MHRA) we would be interested to analyse the profile of any reported problems. Our classification of these appliances has been helpful to identify the regulatory grey area of custom made splints made using self-recorded impressions.
Commentary
The use of the Internet by members of the public to research aspects of their healthcare has been widespread for over a decade1 and long-gone is the attitude that 'a doctor knows best.'2
Instead clinicians now spend considerable amounts of time discussing treatment options with more enlightened patients. However, in some instances this may include time spent disabusing an individual of the merits they perceive would accrue through following a clinically inappropriate Internet option that they have researched.1
While it is acknowledged all clinical practice ideally should be based on scientific evidence, the reality is that when this is lacking an empirical base prevails.3
In such circumstances, the unsubstantiated claims from manufacturers are enticing and with the growth of products for sale on the Internet, it is hardly surprising that clinicians are tempted to succumb to beautifully illustrated clinical outcomes in marketing promotions.4
Imagine then the enticement for an innocent, undiscerning member of the public who is able to buy certain dental products direct from the manufacturer.
At least with a patient who attends a clinician requesting the implementation of an Internet option there is the opportunity to temper their enthusiasm with appropriate professional advice, if necessary. Not so for people who are able to purchase their medical devices directly on-line.
In such circumstances, not only is the potential benefit of clinical advice being circumvented, but the fact that a self-prescribed intervention is being used is also obscured from the health professional.
As such, this paper describes the current situation for over-the-counter (OTC) bruxism splints that are available for purchase by members of the public via the Internet. The various different splints are classified according to their characteristics, web-based safety warnings and CE marking claims are investigated, comments are made on the potential for these unsupervised splints to adversely affect oral health and advice is given regarding the regulation of these medical devices.
In comparison to the USA, the number of UK websites is much smaller but is definitely growing. This was evidenced by repeating the Internet search four months after the initial investigation during 2013. Over this time, the UK market had increased by 68% but alarmingly, the number of sites that failed to give any safety warnings for their OTC bruxism products had reached 38%, with a noticeable trend for previously compliant safety-conscious sites reducing, if not eliminating their earlier warnings.
Overall, this article indicates it would behove dentists to periodically enquire into the use of patient self-prescribed oral products through recurrent health questionnaires in order that their possible existence, efficacy and potential effect on the dentition can be established, evaluated and monitored.
References
John J . Sources of evidence. Evid Based Dent 2003; 4: 37–39
Brands WG . The standard for the duty to inform patients about risks: from the responsible dentist to the reasonable patient. Br Dent J 2006; 201: 207–210
Shaw W C . How relevant is the evidence-based process in orthodontics? Evid Based Dent 2000; 2: 7–8
O'Brien K, Sandler J . In the land of no evidence, is the salesman king? Am J Orthod Dentofac Orthop 2010; 138: 247–249
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Chate, R. Summary of: Over-the-counter (OTC) bruxism splints available on the Internet. Br Dent J 216, 642–643 (2014). https://doi.org/10.1038/sj.bdj.2014.480
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DOI: https://doi.org/10.1038/sj.bdj.2014.480
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