Over-The-Counter (OTC) Bruxism Splints Available on the Internet Splints Available on the Internet

Over-the-counter (OTC) bruxism IN BRIEF • Raises awareness and categorises the RESEARCH types of over-the-counter (OTC) bruxism splints available on the Internet splints available on the Internet. • Highlights the potential pitfalls of patients purchasing an OTC bruxism R. W. Wassell,*1 L. Verhees,1 K. Lawrence,1 S. Davies2 and F. Lobbezoo3 splint without consulting a dentist. • Provides advice on the UK regulation of these appliances. VERIFIABLE CPD PAPER • Stresses that dentists should report suspected adverse events with OTC splints to the relevant authority.

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).

INTRODUCTION Bruxism is a persistent but fluctuating many authorities still recommend full coverage Bruxism, as recently defined by an problem in many subjects.3 stabilisation splints2 to spread occlusal contact international expert group, is ‘a repetitive While patients can be counselled to help optimally5 and avoid unwanted occlusal jaw-muscle activity characterised by control awake bruxism other methods are changes.5–7 The full coverage stabilisation clenching or grinding of the teeth and/or by needed to control sleep bruxism, particularly splint, which is also used extensively for the bracing or thrusting of the mandible. Bruxism when patients develop associated symptoms management of some temporomandibular has two distinct circadian manifestations: it of jaw or tooth pain, or where they wish to disorders (TMD), is generally regarded as a safe can occur during sleep (indicated as sleep protect teeth or restorations from damaging option.8,9 Clinically when adjusted properly it bruxism) or during wakefulness (indicated occlusal forces. It should be emphasised that works well for many sleep bruxism patients, as awake bruxism)’.1 It is a common disorder while the occlusion is at the receiving end but it is not a panacea with the response of affecting an estimated 16% of the adult of parafunctional activity it is not the cause patients being variable and unpredictable.10 population for sleep bruxism and 24% for of it and sleep bruxism is now regarded as While the stabilisation splint does not awake bruxism.2 Clearly some subjects a centrally-mediated, sleep-related disorder.4 efficiently treat bruxism in all patients it is will be affected by both types of bruxism. Consequently, it is inappropriate for dentists often used over long periods to protect the to recommend invasive treatments to teeth in patients who continue to brux.10 correct occlusal discrepancies as a primary Contraindications to this type of splint are 1 Department of Restorative Dentistry, The School of 11,12 Dental Sciences, Framlington Place, Newcastle upon treatment for bruxism (although in order to not absolute but include sleep apnoea and Tyne, NE2 4BW; 2TMD Clinic, Dental School, Higher improve predictability, it is sensible to avoid unstable disc displacements with reduction.13 Cambridge Street, Manchester, M15 6FH; 3Department incorporating occlusal discrepancies in bruxists Another type of full coverage splint is the of Oral Kinesiology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and VU who require restorative treatment). Nowadays, soft splint – a popular choice with many University Amsterdam, MOVE Research Institute Am- non-invasive treatments for bruxism are dentists, being quick and easy to fit. Clinically sterdam, Amsterdam, The Netherlands recommended including occlusal splints of some patients are happy with this appliance, *Correspondence to: R. W. Wassell Email [email protected] various designs supplemented by advice and but others find their bruxism aggravated occasional pharmacological intervention. more than in patients wearing stabilisation Online article number E24 Despite the lack of substantial scientific splints.14 Whether this effect results from the Refereed Paper - accepted 23 January 2014 DOI: 10.1038/sj.bdj.2014.452 evidence supporting any particular splint resilient nature of the material or the splint’s ©British Dental Journal 2014; 216: E24 design as being effective in reducing bruxism unprescribed occlusion is not known.

There are also dentists who advocate The following information was recorded Table 1 Search engines and phrases used to locate OTC splints available the UK and partial coverage splints such as the NTI- for each OTC splint: the name of the determine if also available in the US TSS splint, which in some patients may manufacturer, name of the device, its UK Search engines used successfully reduce clenching6 or may be price and any claims and safety warnings www.google.co.uk helpful as a short-term treatment for acute made either on a major UK retail website or www.google.com TMD. However, to avoid unwanted occlusal via other UK web retail outlets. In addition, a Amazon.co.uk changes, dentists fitting such appliances are note was made of any web-based mention of Amazon.com advised to fit them only in those patients ‘CE marking’, indicating compliance with the Search phrases used who are likely to be compliant with EC Medical Devices Directive’s requirements ‘Bruxism protection’ follow-up appointments.6,9 for safety, quality and performance. In the ‘Bruxism guard’ Nowadays, the Internet has added a context of performance this does not need ‘Bruxism mouth guard’ new dimension to dentistry. Not only are to be supported by clinical trial data to ‘Bruxism appliance’ individuals increasingly aware and informed show efficacy and safety if a manufacturer ‘Night guard’ of health related conditions they can now or supplier submits a medical device ‘Occlusal splint’ obtain over-the-counter (OTC) appliances as low-risk. ‘Occlusal bite guard’ online as a possible alternative in an attempt The manufacturer’s claims posted on the to manage their bruxism (also for snoring UK websites were tabulated and two of the ‘Bite plate’ and sleep apnoea) without the need for a authors (RWW and LV) categorised them dental or medical consultation. In the context into a number of common themes. A similar to generate additional hits. These included all of this paper an individual buying an oral approach was made for any caution notice the generic terms derived from the product device without advice or supervision of an or safety advice existing on the relevant UK names in Table 2 (‘grinding guard’ ‘grinding appropriate dental healthcare professional website. gard’, ‘night guard’, ‘nightguard’, ‘night- is termed a ‘consumer’. A ‘patient’ is defined A classification of OTC bruxism splints was guard’, ‘bite guard’, ‘dental splint’, ‘dental as an individual under treatment by a dental devised by grouping the splints according guard’ and ‘bruxo’) and the product names healthcare professional. An individual may to similarity in design. The classification themselves. Reports of reactions to splint be both a patient and a consumer if they considered the broad type of design and cleaning products were not included, neither omit to tell their dentist that they are using whether it potentially provided full coverage were in-surgery devices customised by the an OTC splint. of all the teeth in one arch or was specifically dentist. By carrying out the search on the OTC splints originated in the US but are partial coverage. The classification also same computer all previously viewed database increasingly available in the UK and other took into account splint adjustability. In entries were highlighted allowing irrelevant parts of Europe. Companies are distributing order to check appropriate classification a products and those previously selected to be online and via other commercial outlets (for splint from each manufacturer was ordered excluded. Each set of searches was saved as a example, pharmacies and supermarkets). on line for physical inspection. In all, Word file. Any duplicate entries were excluded There is also a trend for some dentists to 22 splints were ordered, including three OTC and multiple reports for the same incident sell OTC appliances directly to patients. impression systems. were collated into a single entry. For each OTC splints come in a variety of designs The Internet search was repeated (04/07/13) entry the reporter (manufacturer, consumer allowing them to be fitted to different using the same protocol to corroborate the or dentist), incident summary and date were jaw sizes. findings of the March survey. This July identified. Common themes to describe The aim of this paper is to survey OTC survey identified any further splints being the various incidents were agreed between bruxism splints available to individuals in marketed in the UK as well as any additional three of the authors (RWW, FL and SD). the UK via the Internet, categorise their or changed claims and safety warnings. A characteristics, and determine any web- note was made of any splints no longer RESULTS based claims or safety warnings. Further, being sold since the first survey and any The splints available from UK websites an online search was made for possible identified checked online (15/07/13). The and their characteristics are summarised in complications including unwanted occlusal web pages were all copied via the ‘print Table 2 with sub-tables explaining the codes change. Finally, advice is given regarding screen’ command and saved as Word files used to summarise the manufacturers’ claims the UK regulation of these appliances and allowing the table contents to be cross- and the Internet-based safety warnings. Table the need for appropriate reporting. checked by a second investigator. 2 shows splints available in both the March and July surveys with the boxes shaded light MATERIALS AND METHOD Online search for grey identifying splints introduced after the An Internet search was made (10 March 2013) associated adverse events March survey. Prices, manufacturer’s claims of OTC bruxism splints available in the UK To determine if OTC bruxism splints had and Internet-based safety warnings relate and determine if these were also available been associated with any adverse events to the July survey. Where any significant in the US. The search engines and phrases a generic search in the US Food and Drug change in claims or safety warnings had used are shown in Table 1. With each search Administration’s (FDA) ‘Manufacturer and taken place between the two surveys these phrase ten search engine pages were searched User Facility Device Experience Database’ are mentioned within the text below. for OTC bruxism splints. Sites were identified (MAUDE)15 was carried out. The following In the March survey a total of 22 different as UK sales points if prices quoted were in strategy was used: Go to simple search → splints supplied by 13 manufacturers/ pounds sterling or US sites if in dollars. search term: bruxism; date report received by suppliers were identified with all but one of For each OTC splint the name of the splint FDA: ALL YEARS (that is, between 1992 and the manufacturers selling their products via was used as a search term and pursued for 2013). The results were hand searched a single major UK retail website. One of the ten search engine pages to determine the to select OTC bruxism splints from other splints is not shown in the table as it was respective retail outlets. products. Subsequent search terms were used no longer available in the July survey. This

Table 2 Master table showing four categories of splint design available in the UK with prices, coded claims and safety warnings. Survey data for July 2013 Split design Adjustability Manufacturer/ Device name Price Manufacturer Safety supplier claims warnings Unretentive One size fits all TotalGard Physiogard Nightguard £13.99 B, D* 3* gutter Trimmed with (‘Full coverage’) scissors Physiogard Nightguard Stressgard II Biteguard £26.99

OnceAll OnceAll Dual Layers Dental Teeth Boxing Mouth £15.49 C - Guard Stop Night Teeth Grinding Bite Pads on One size fits all SleepRight Dental Guard Dura- Comfort £30.00 D*, F*, J*, 6*, 21* posterior teeth Self-adjustable (‘Partial pads; Dental Guard Secure-Comfort £28.00 coverage’) with 4 settings Dental Guard Slim-Comfort £29.95

One size fits all Dentek Comfort Fit Dental Guard £31.00 D* - Self-adjustable pads; with 5 settings Boil & bite One size fits all 2PLUS2 Pair of Night Guards Mouth Guards for Bruxism £29.97 B 2, 15, 16, 17, (‘Full coverage’) Trimmed with 18, 19, 20 scissors BruxPerformance ** BruxoGard £24.34 A*, D*, F*, H*, J* 6*, 14* 24*, 25*, 26* PowrGard 4Braces £24.34

Dentek Custom Comfort Dental Guard (twin pack) £17.27 - -

Maximum Protection Dental Guard £29.98 D, F, G 2*, 6*, 10*, 12*, 13*, 16*, 17*, 27*, 28*, 29*, 30*, 31*, 32*, 33*, 34*, 35*, 36*, 37*, 38* Dr Brux Dr Brux Mouthpiece (generally unavailable except £61.00 C, H - via Italian supplier trading in pound sterling) Icebrite Pair of Night Guard Mouth Guards to Prevent Teeth £3.95 A, C, D - Grinding Mammoth Grinding Teeth Guard (Bruxism); Berry Flavour £5.49 D - Supplements Sleep Solutions Sleep Solutions Bruxogard Soft Mouth Guard £24.43 B*, D, E - (Myofunctional Research Co) Sleep Solutions Bruxogard Hard Mouth Guard £35.27 B* 8

2PLUS2 Thermoforming Mouth Trays for Teeth Grinding/ £1.25 - 1 Bleaching/ Whitening AllThingsLovelyJubbly Stop Snoring Anti Snoring Device Sleep and Mouth £10.99 C 6, 15, 22, 23 Piece Guard Teeth Grinding Cure Archtek Grinding Guard – Relieves Symptoms Associated £10.70 A*, B*, D - with Teeth Grinding Doctors Med Tech Products Doctors Nightguard Advanced £23.65 C*, D* - Comfort MAKS 2pcs Replacement Thermoforming Mouth Trays/ £1.99 - - Guards for Teeth Whitening/ Bleaching or Teeth Grinding Mammoth XT Bruxism Grinding Teeth Mouth Guard- Sleep Gum £5.99 A, D - Shield / Night NightGuard / Boil n Bite - Spearmint Mammoth XT Pair of Teeth Grinding Mouth Night £19.99 A, D - Guard - Bruxism Smile 4 You Replacement Thermoforming Mouth Trays/ Guards £2.48 - 9 for Teeth Whitening/ Bleaching or Teeth Grinding Start Here 4x Replacement Thermoforming Mouth Trays/ £0.01 - - Guards for Teeth Whitening/ Bleaching or Teeth Grinding Top Choice Replacement Thermoforming Mouth Trays/ Guards £2.35 - 9 for Whitening/ Bleaching or Teeth Grinding

Continued on page 4

Table 2 Master table showing four categories of splint design available in the UK with prices, coded claims and safety warnings. Survey data for July 2013 Continued from page 3 Self-impression Splint made Nightguard Direct Professional Custom Made 2 mm Night Guard £55.00 D, F, H* - kit by dental Ltd (“Full coverage”) laboratory Professional Custom Made 3 mm Night Guard £55.00 D, F, H* -

Professional Custom Made Dual Laminate £55.00 D, F, H* 7* Night Guard Smiles 4 Less Dental Teeth Grinding Night Guard – Custom Fit £44.99 H 4 (3 mm moderate grinding) Lower Teeth Dual Laminate Teeth Grinding Night Guard – Custom £54.99 Fit (2mm heavy grinding) Lower Teeth Dental Teeth Grinding Night Guard – Custom Fit £39.99 (2 mm minimal grinding) Upper Teeth Dual Laminate Teeth Grinding Night Guard – Custom £59.99 Fit (3 mm severe grinding) Lower Teeth ProWhite Direct Night Guard for Teeth- Grinding/ Bruxism - Dental £29.99 H 5 -Professional - Custom Made - 2 mm Night Guard for Severe Teeth Grinding/ Bruxism, £44.99 2 mm Dual Laminate - Dental - Professional - Custom made Night Guard for Severe Teeth Grinding/ Bruxism, £49.99 3 mm Dual Laminate - Dental - Professional - Custom made

Key: Grey shading indicates splints appearing on market since the March Survey. Also available in the US. **Only available direct from supplier (not on main UK retail website); * Information available only on manufacture’s/supplier’s website (not on main UK retail website) was a laboratory made splint made from formed splint is custom made by the Table 2. Again, some of this information a self-recorded impression. Eleven of the laboratory and returned to the individual. was only available on the manufacture’s/ 22 splints available on UK websites were also supplier’s website. One splint was supported available on US websites. In the July survey As only one manufacturer mentioned CE by a comprehensive list of 19 safety items, the number of splints available in the UK had certification online this information was not but 14 splints carried no safety information risen to 37 and the number of manufacturers/ tabulated. The need for CE certification to on their websites. Detailed safety notices suppliers to 23. Twelve of the 37 splints were accompany the product when delivered to comprising 15‑16 items were provided for also available on US websites. the end-user will be raised in the discussion. five splints in the March survey, but in the Four generic designs were identified, OTC bruxism splints ranged in price from July survey these had all been removed by three of them having the potential for full £0.01 to £61.00, but postage and packing could one manufacturer and reduced to two items coverage while one design was intentionally add as much as £17.00 to the price, particularly by another. Strangely, one manufacturer in partial coverage: if the appliance was sent via a UK retail website the March survey advised their Grinding 1. The unretentive gutter – a U shaped but from a supplier outside the UK. Some Teeth Guard; Berry Flavour ‘Not to be used plastic device placed between the dental appliances are sold in packs of two or four. as a nightguard to prevent against bruxism’, arches and adjusted by the individual The types of manufacturers’ claims for however, in the July survey that solitary with scissors their products can be seen in the sub-table (i) warning had been removed. There was an 2. Bite pads on posterior teeth – the of Table 2. Some of the claims were available inconsistency in the minimum age with pads are connected bilaterally to on the main UK retail website while others three manufactures each recommending buccal flanges in the molar/premolar were only available on the manufacture’s/ 10, 14 and 16 years respectively. A further regions. The buccal flanges are in turn supplier’s website. The most common claim three manufacturers set the minimum age connected by a thin plastic strap that (16 splints) was ‘Protects teeth/restorations at 18. No minimum age was mentioned by sits in the lower buccal sulcus. The from grinding /clenching/bruxism’. Other the other 17 manufacturers. individual can adjust the pads using a commonly made claims (four to six splints) Only two manufacturers provided a guide number of different settings depending suggested that splints ‘Protects the TMJ’ to how long each day the splint should on lower arch size. As with the or ‘Cures/treats/reduces/helps/prevents be worn. One recommended no more ‘unretentive gutter’ there is no retention bruxism’ or reduces unspecified symptoms. than 12 hours in each 24 hour period for provided from the teeth with the inter- Five products carried a claim of ‘Headaches/ 3 months before consulting a dentist. The occlusal portion balanced between the facial pain/jaw pain reduction’ while other endorsed wear of the splint throughout upper and lower arches one claimed to improve sleep/reduce sleep the day or the night to help relieve tooth 3. Boil and bite – Fitted in the same way as disruption. Six products claimed to be grinding symptoms. a thermoplastic sports mouth guard and similar to professionally made splints but adjusted by the individual with scissors less expensive. Some manufactures/suppliers Online search for 4. Self-impression kit – The individual is made claims about splints in general but not associated adverse events sent an impression kit (tray and putty) necessarily about the product on sale. The results of the MAUDE adverse events and returns the self-made impression to There was a variety of Internet-based database are shown in Table 3. In total a commercial laboratory. A soft, vacuum safety warnings as seen in sub-table (ii) of 20 reports were identified relating to those

Table 2(ii) Codings for manufacturers’ Table 2(i) Codings for manufacturers’ claims in main table claims in main table Code Manufacturer claims Code Caution notice on the Internet - No claims - None Not to be worn to prevent against A Headaches/facial pain/jaw pain reduction 1 bruxism B Unspecified symptom reduction 2 Not to be worn as a sports guard C Cures/treats/reduces/helps/prevents bruxism 3 Not for persons <10 years old D Protects teeth/restorations from grinding/clenching/bruxism 4 Not for persons <14 years old E Protects TMJ from grinding/clenching/bruxism 5 Not for persons <16 years old F Claims similar but less expensive than professionally made splint 6 Not for persons <18 years old G Improves sleep/reduces sleep disruption Only for use when recommended by 7 H Generic claims about splints not specific to product on sale a dentist 8 For night time use only J Other (eg most durable, years of success, re-establishes space between upper and lower teeth) 9 For mild grinders only

Table 3 Search results from the FDA’s MAUDE database for adverse events associated with Do not use: OTC bruxism splints For more than 3 months without 10 Search term OTC bruxism Total hits Previous hits Irrelevant consulting your dentist For more than 6 months without splints products 11 consulting your dentist Bruxism 12* 118 0 106 If your dentist has told you that you 12 have TMJ pain or clicking Grinding guard 4 14 4 6 If you have tooth pain from grinding 13 Nightguard 4 18 8 6 or any other tooth or jaw pain 14 If you have jaw problems Specific products** 1 16 8 7 15 If you have tooth or gum problems Total number of incidents 20 With dentures, braces or other dental 16 appliances eg implants *One event appeared to generate two reports **Products shown in bold from Table 2 With loose teeth, loose fillings or loose 17 crowns found for the OTC bruxism splints. Only for consumers based on a three step self- 18 A bridge the generic terms ‘bruxism’, ‘grinding help philosophy of awareness, accountability 19 Advanced periodontal disease guard’ and ‘nightguard’ generated relevant and behaviour modification). However, this 20 Several missing teeth entries; one further entry was discovered by rapidly emerging market in the UK throws up 21 For >12 hours in a 24 hour period sequentially entering all the product names. a number of important issues that the dental Summaries of the adverse events are shown profession should be aware of. 22 If you suffer from sleep apnoea in Table 4 while the themes describing Currently, UK dentists may be unaware 23 If you suffer from epilepsy the types of event are shown in Table 5. that consumers can bypass some of their Consult a dentist before use if you: Eleven adverse events were reported by professional services by way of the Internet. manufacturers and nine by consumers. No Indeed, they may well have patients using 24 Have tooth or gum problems reports were made by dentists. All of the OTC appliances who fail to volunteer this 25 Wear a denture or brace reports except three were made between information. As with the prolonged wear of 26 Are under 14 years of age 2008 and 2013. any intra-oral appliance individuals may be Have major health problems or serious at greater risk of developing dental problems 27 DISCUSSION breathing problems (for example, unwanted occlusal changes, Oral sores, bleeding gums or any gum 28 This Internet survey clearly indicates the mucosal trauma and dental disease where disease variety of OTC bruxism splints currently the oral hygiene is inadequate). 29 Cavities with no fillings available to individuals in the UK. From OTC bruxism splints have been available 30 Difficulty chewing a customer’s perspective this market may in the US for almost 20 years and are 31 Pain of the jaw, teeth or face appear attractive giving freedom of choice a thriving business. Indicative figures and being less expensive than a splint fitted from one manufacturer suggest several 32 Two or more missing teeth and followed up by a dentist. It also saves hundred thousand splints sold annually in Stop using the splint and ask a dentist if: time waiting for a dental appointment. The the US and increasing sales in Europe. In Soreness, bleeding gums, teeth loosen 33 manufacturers and suppliers of OTC bruxism our March survey over half of the companies or reaction occurs in mouth splints can also claim directly (through online selling OTC splints in the UK originate from the Pain develops e.g. jaw, teeth or ear pain 34 or printed information) or indirectly (through US indicating an intention to grow the market or headache The splint causes gagging, discomfort promotion and advertising) to have raised this side of the Atlantic. However, our July 35 or falls out of the mouth easily awareness of bruxism to consumers and to survey showed only one further US company the dental profession. Indeed, there is some entering the UK market, which had increased 36 A change in the bite is noticed potentially helpful information available in 4 months by 68% (in terms of number of 37 Neck stiffness or joint clicking develops to consumers about awake bruxism (for different splints). Some of the companies most The same symptoms persist after one 38 example, SleepRight provides information recently entering the UK market appear to month of use

Table 4 MAUDE adverse event summaries (n = 20) from all specified search terms showing Table 5 MAUDE adverse event categories who made the report (consumer C, dentist D or manufacturer M) coding the type of problem and codings based on reports in Table 4 according to Table 5. (MAUDE database updated 30.11.2013) Type of adverse event Code Reporter Incident summary Incident C, D, M code Scalding 1 C Scalding of consumer’s hand and face caused by microwave heated water 1 contained in a drinking glass. On immersing the splint the water “exploded” Gingival irritation and discomfort 2 boiling up steam and superheated water over consumer’s skin. Gingival damage or recession 3 M Uncomfortable splint which consumer considered was causing severe gum 2, 6 irritation and loss of a filling. Mucosal reaction 4 M Gingival recession around lower molars requiring surgical intervention – possibly 3 Cracked, damaged or painful tooth 5 caused by splint. Claim supported by manufacturer’s insurance in view of dentist’s contention that appliance may have been causative. Lost or damaged restoration 6 M Open sore developed in gums after wearing splint for 3 days. Plastic material 3 (possibly from splint) impacted into gum requiring surgical removal resulting in Splint broken in use (+/- choking) 7 bone and gingival tissue loss. Device available for evaluation but packaging not Splint swallowed/part swallowed during kept so lot number unknown. 8 sleep (+/- choking) C Painful blisters inside mouth after wearing splint for one night. Splint no longer 4 TMD (diagnosis part-confirmed by worn and blisters resolved 9 dentist) M Tooth pain after one night of wearing splint. Patient reports dentist diagnosed a 5 cracked lower molar on each side of her mouth. Occlusal change 10

M Splint broke apart and tooth damage. Consumer considered damage caused 7, 5 Systemic reaction 11 by the way her teeth grind on splint. Manufacture requested product from consumer to investigate, but no response. Product contamination 12 C Splint broke during sleep. Consumer (occupation risk manager) perceived a 7 choking hazard. M Consumer woke with pieces of the splint stuck in her throat after only two nights 7 General Dental Council (GDC) who have been of wearing the device. Concern over possibility of aspiration. made aware of the situation. M Appliance partly swallowed during sleep. Wife woke husband because of his 8 The proposed classification system choking noises and retrieved appliance using her fingers. Emergency room provides a useful tool to differentiate treatment required, possibly due to pharyngeal injury during removal. between the growing numbers of OTC M Appliance partly swallowed during sleep causing gagging. Patient able to 8 bruxism splints available. An interesting self-retrieve. trend observed with the July survey is the M Appliance partly swallowed during sleep causing gagging. Patient able to 8 marketing of several multi-purpose devices self-retrieve. to be used not only for bruxism but also M Appliance completely swallowed during sleep two weeks prior to contacting 8 as anti-snoring appliances (one product) manufacturer to demand refund. or bleach trays (five products). Readers C ‘Lock jaw tmj’ after wearing splint for only 7 hours. Told by dentist condition 9 should be aware that while ‘boil and bite’ could last for years. Patient aggrieved as splint bought only to treat bruxism. No OTC bruxism splints closely resemble sports mention of TMD history. mouth guards in appearance the former are M Progressive occlusal change after one year of wearing splint every night. 10 classified by the MHRA as medical devices Dentist advised patient to discontinue splint wear but teeth continued to move over following year resulting in “teeth not closing”, development of a 5mm while the latter are not. Consequently, sports anterior open-bite, chewing difficulties and development of a lisp. Dentist mouth guards that are used intermittently supporting patient in upgrading case to serious. Remedial orthodontic treatment for short periods are not governed by the recommended. same regulatory framework. However, if an C Bite has changed and jaw pain after using splint for one month. Splint no longer 10 OTC sports mouth guard were marketed for used but symptoms persist. the purpose of managing bruxism it would C Gave consumer ‘bad gas’ during 5 months of wear. Event abated after use 11 be regulated in the UK by the MHRA. stopped. There are a number of significant pitfalls C ‘Brown stuff” in mouth followed by general malaise for 3 days. Consumer 11 with consumers buying OTC splints and suspects contamination or chemical leaching from splint. bypassing their dentist. Not least, it relies C Consumer concerned product needed a safety seal packaging as it appeared that 12 on the consumer self-diagnosing their other products on the shelf had been opened and handled. condition, which may be more complex than C ‘Dried blood’ noticed on splint being sold at drug store suggesting it had already 12 simply one of tooth grinding and clenching. been used. For example, a consumer with facial pain may buy an OTC splint in the hope that it be UK based, but it is difficult to determine will consider the UK regulation implications of will solve the problem, but the pain may from where many of them are trading and both mass produced and custom made devices have little or nothing to do with bruxism and whether any are offering the same product, later in the discussion. However, the practice the opportunity for a professional diagnosis but under different names. Companies include of laboratories supplying an OTC impression may be delayed or lost. Alternatively, a some dental laboratories. These laboratories kit and a custom made appliance currently consumer may be diagnosed by their dentist, sell an OTC impression kit but supply a splint falls in a regulatory grey area. The Medicines but buy an OTC splint because they find the customised to fit an individual customer. and Healthcare products Regulatory Agency one provided by their dentist too expensive By the time of the July survey one of these (MHRA) considers it to be a matter for the or too onerous in terms of follow-up laboratories was no longer advertising. We professional bodies, which in the UK is the requirements. While one manufacturer

states in their Internet safety warning that consumer has up to 3 months and 7 days). by dentists, but two consumers had been consumers with jaw or tooth pain should ask If they are dissatisfied for any reason they advised and supported by dentists where their dentist before OTC splint use, there are can return the goods for a full refund. extensive remedial treatment was required. 22 manufacturers in the July survey who Similar provisions apply to sellers based in Some reported events are of concern, make no such recommendation. Consumers the EU. Assuming the product arrives with particularly the choking hazard caused by may be further confused when they read on the necessary cautions and instructions the individuals swallowing or inhaling parts one site that an OTC splint may be used to consumer has in theory sufficient time to of a broken appliance or indeed occasions treat jaw pain but other sites say that jaw consult the manufacturer or their dentist if where the splint is swallowed whole. pain is a contraindication to use. It would they require further clarification. In practice Patients may wrongly associate local and be interesting to know how many consumers how many take the trouble to do so is unclear systemic symptoms with the wear of an OTC with jaw or tooth pain do consult their and may be worthy of further research. splint. Nevertheless, gross gingival trauma, dentist after browsing an OTC website or, Consumers will assume that the materials development of trismus (‘TMJ lockjaw’) having bought the splint, after reading the used to make these splints are safe. Clearly, and changes to the occlusion are events accompanying instructions. some splints have the potential to leach that clearly should not be ignored. We will Consumers browsing with the intention of substances intra-orally as illustrated by the return to the issue of occlusal changes in the buying an OTC bruxism splint online may berry and mint flavours of two products. To following section. find it difficult to gauge how safe these what extent other substances (for example, We acknowledge that this type of search products are: most web sites (including the phthalates) leach out is unknown. Under will have shortcomings particularly in major UK retail website and those of the current regulatory arrangements (see respect of under reporting recognised by suppliers/manufacturers) either have no below) manufacturers are not obliged to the FDA.15 Furthermore, the reports are not safety warnings or only mention a lower submit clinical trial data for their products evidence of proof of causation. Neither is age limit. Even then they fail to agree showing both safety and efficacy. Neither are there sufficient of them to show superiority whether this should be aged 10, 14, 16 or there specific ISO (International Standards of one product over another or to identify 18 years. Where safety information is given Organization) standards for the materials features of a product predisposing to it is unknown to what extent consumers these products are made from as there are particular adverse events. Reports of comprehend or comply with it. Moreover, for polymeric materials used in dentistry (for contaminated or potentially contaminated manufacturers and suppliers may decide example, denture and orthodontic bases).17 packaging relate to sales from shops rather for whatever reason to remove safety However we understand ISO is becoming than Internet trade. notices from websites so that information aware of the need to consider this further. OTC bruxism splints have been available regarding potentially deleterious effects of With regard to efficacy Table 2 shows for almost 20 years but MAUDE consumer appliances is no longer available to potential a wide range of claims being made by reports have only really started in the past customers. This action was observed with manufacturers for their products, but it is 5 years. Until recently reporting has not been two manufacturers when we repeated our difficult to know on what basis they are easy for consumers. The FDA now recognises Internet survey in July, but we understand being made as there is no published research that the reporting form is ‘too technical’ that manufacturers and resellers are not regarding OTC splints. Claims stating that a and has collaborated with consumer groups legally obliged to give full information splint will cure bruxism, reduce headaches to produce a more user friendly version.19 online. However, they are obliged to do so and facial pain or improve sleep quality need Nevertheless, consumers and dentists need to when the product is delivered to the end to be viewed with particular caution. While know that regulatory reporting is expected user. As well as providing information, the some claims allude to splints in general, of them; if not, under-reporting may product needs to be marked with a ‘CE’ mark consumers may not unreasonably assume well continue. indicating compliance with the Medical that these apply to the splint on sale without Despite the reports on the MAUDE database Devices Directive, considered later in the realising that it has no published trial there are no published case reports. This may regulatory section of the article. results. In the UK the Advertising Standards indicate that problems rarely occur with OTC It is worth emphasising that the major Authority is responsible for enforcing codes bruxism splints. However, there are case UK retail website, where all but one of the relating to medical device advertising. reports and trial data showing occasional products are sold, issues a legal disclaimer These codes are written and maintained by problems with professionally fitted appliances in relation to the web-based information the Committee of Advertising Practice.18 So for example, stabilisation splints,13 soft for all their healthcare products. The far we are unaware of any manufacturer’s splints7 and partial coverage appliances.6 disclaimer advises consumers not to rely claims made for OTC bruxism splints being The recurring theme with these reports is the on this information for self-diagnosis or scrutinised by the ASA. possibility of unwanted tooth movement and self-treatment. In addition, consumers are occlusal change – particularly with partial advised to read the information and safety Online search for coverage splints. warnings that come with products. If the associated adverse events consumer purchases from a UK-based seller, The search of the MAUDE database Unwanted tooth movement they are covered by the UK Distance Selling provided a qualitative analysis of the type and partial coverage splints Regulations.16 This provides protection for of problem generically associated with OTC All of the OTC splints surveyed in this study consumers when they enter into a contract bruxism splints. Although derived from had the potential to be partial coverage, with an online supplier. The consumer the American experience this information either by design or as a result of simply has 7 working days from the day after should be helpful to dentists and consumers not fitting the full arch. This misfit between the receipt of the goods to examine the in the UK. We made no attempt to identify splint and arch may occur following goods and determine if they are suitable specific manufacturers and splints, although adjustment of a ‘one size fits all splint’ by (some manufacturers offer 14 days, but if ‘boil and bite’ splints can be recognised from an individual using scissors. Alternatively, no information on returns is provided the the scalding incident. No reports were made individuals recording their own impressions

before splint construction may not include these posterior open bites resolved with published case reports of this occurring all of the teeth. They are after all not trained time was not reported. Clearly, the full-time with OTC bruxism splints. Perhaps one of the in recording impressions, and taking a good wear of a Gelb appliance incorporating reasons is not being 100% sure about proof impression on yourself would represent a indentations which hold the jaw forwards is of causation. Individuals buying OTC splints challenge, even for a dental professional. an extreme form of splint therapy. We must will rarely have comprehensive records for The literature reports that partial coverage emphasise that while some OTC bruxism comparison. In the case study below the appliances have the potential to cause tooth splints superficially resemble the Gelb only evidence that the teeth had moved movement via dento-alveolar intrusion of the appliance, they do not have indentations and was based on retrospective information: teeth covered by the appliance and extrusion the instructions recommend sleep use and the patient history, the occlusal analysis or over-eruption of those not covered.20,21 not full-time wear. Consequently, any hazard and the two dental panoramic tomographic The resulting tooth movements can either of producing unwanted tooth movement (DPT) radiographs. Other factors such as the be planned, as part of some orthodontic or should be much less, if used only for sleep unerupted wisdom teeth, differences in x‑ray restorative treatment,21,22 or unwanted.6,7,23 and for limited periods. machines, TMD symptoms and masseteric Indeed, recommendations have been made In the UK dentists routinely create hypertrophy complicate the presentation only to prescribe partial coverage splints interocclusal space of 1‑2 mm for restorative in this case. Nevertheless, where dentists where dentists are sure of patient compliance purposes using the Dahl approach.22 This have a strong suspicion of causation they with follow-up.6,9 tooth movement is often achieved in only have an ethical obligation to assist their The potential for tooth movement will 3‑4 months. Hence, many UK and other patients in reporting safety issues to the increase with prolonged wear of the partial European dentists increasingly recognise relevant regulatory agency. Moreover, if coverage splint. For example, Dahl and the potential for unwanted occlusal change the dentist has prescribed the OTC splint he Krogstad24 showed that 6‑14 months of with prolonged wear of partial coverage or she has a professional obligation to do partial coverage splint wear on the anterior appliances. This clinical experience in so – much in the same way as UK doctors teeth caused a combination of incisor combination with the above studies do with the ‘Yellow card’ system used for intrusion and molar over-eruption. The illustrates the potential for unwanted tooth reporting suspected side effects with drugs. incisors intruded by a mean of 1 mm while movement with any partial coverage splint, This obligation, previously implicit in the molars had over-erupted by 1.5 mm. It particularly in susceptible individuals when GDC’s Standards for dental professionals,30 is generally accepted that orthodontic tooth worn for protracted periods. has become explicit in the new Standards intrusion is not easily achieved but incisors If a consumer buys an OTC bruxism splint published September 2013.31 Indeed, both have the potential to intrude more than without the knowledge and supervision of the General Medical Council32 and the Royal molars (mean values of 1.5 mm compared a dentist, then the potential for unwanted College of Surgeons33 are now also keen to with 1 mm).25,26 Other studies have shown occlusal change is increased as the consumer emphasise the responsibility of health care that following extraction unopposed teeth may not be looking out for it. Furthermore, professionals in reporting problems with can erupt to varying extents in different the insidious nature of occlusal change may medical devices. patients ranging from 0.5 mm to 5.4 mm.27 allow a considerable change to occur before The Gelb appliance is a partial coverage the consumer becomes aware of a problem. It Case study: occlusal change suspected splint, which is a custom made appliance is assumed that many patients will buy OTC to be associated with an OTC splint for TMD, enjoying a period of popularity bruxism splints for overnight wear to control A 22-year-old male patient was referred during the 1980s and 1990s. This appliance the effects of sleep related bruxism. In this to Newcastle Dental Hospital with a 6 year only covers the posterior teeth leaving the respect splint wear occurring during the hours history of bruxism and more recently anterior teeth separated. We know from of sleep may be considered ‘short-term’ and disturbance in his occlusion. The patient clinical observations and from study results an assumption, backed by some bodies of explained that his teeth met prematurely at that in some patients prolonged wear of expert opinion, made of low risk. However, the back of his mouth and was increasingly the Gelb appliance results in posterior patients with both awake and sleep related aware of sliding his lower jaw and teeth open bite, particularly when worn full- bruxism may decide to wear their splints for to improve the number of teeth meeting. time.28 Brown et al.28 reported a study longer periods, particularly if the instructions In addition, he had a dull pain over the of 64 patients wearing Gelb appliances that come with the splint are unclear about insertion of left masseter and left masseteric for between 6 months and 4.8 years. A the potential hazards of unwanted tooth hypertrophy. subgroup of 16 patients had complete movement and the need to limit the amount Previous treatment by his dentist had radiographic records (lateral cephalographs) of splint wear. The low level of evidence based included the provision of lower soft splints with the splint removed before and after on expert opinion also needs to be born in to address his bruxism while his left sided treatment. All 16 of them had developed mind.29 Clearly, it would be helpful if the masseteric hypertrophy was managed by the posterior open bites following treatment. question of what constitutes a safe period maxillofacial surgeons with botox injections. Various significant tooth intrusions and of wear of a partial coverage splint could be He repeatedly perforated the lower soft extrusions were reported for the 64 patients answered with a properly conducted clinical splints around the canine regions, so in using measurements recorded from the trial. Sufficient numbers of patients would of January 2011, unbeknown to his dentist, radiographs. However, the mandibular course be needed to ensure the trial included he purchased an OTC bruxism splint over molars did not show significant intrusion. those who were susceptible to unwanted the Internet. He continued to wear the self- Such measurements may have been subject tooth movement. The ethical considerations prescribed appliance each night for 8 months, to inherent methodological limitations.12 of undertaking such a trial would of course even replacing it when it became too worn. Hence, we are uncertain whether the need careful consideration. However, towards the end of this period he 16 posterior open bites resulted either from Given the potential for unwanted tooth began to notice an increasing problem with changes in tooth position or changes in movement it is surprising there are only his bite when he removed appliance. mandibular posture or both. To what extent two MAUDE database entries and no On examination the patient had a large

slide between the retruded contact position is international the evidence presented by and intercuspal position. The slide had a manufacturers may include certification or 3 mm lateral component to the left. The approval from other authorities (for example, retruded contact was between teeth 27 and the FDA in the US). 37. Clinically both of these teeth appeared Responsible manufacturers need to over-erupted, as did teeth 17 and 47. When comply with the requirements operating in the appliance was placed in the patient’s the country where they wish to sell their mouth it extended only to the distal aspects products. Within the UK and most other Fig. 1 DPT recorded on presentation, of 46 and 36 leaving all the second molars European countries manufacturers of OTC highlighting a distinct step between the uncovered. By contrast, the soft splint bruxism splints must deliver appropriate distal aspects of all four first molars and the supplied by the patient’s dentist covered all literature (indications, instructions and adjacent mesial aspects of the second molars the lower teeth. A DPT revealed a distinct cautions) to the end user and mark their step between the first and second molars OTC products with a ‘CE mark’. The CE (Fig. 1). A previous DPT, which predated the mark indicates compliance with the EC use of the appliance, is shown in Figure 2. Medical Devices Directive’s requirements Diagnoses were made of occlusal for safety, quality and performance. For disruption associated with overeruption of Class I appliances manufacturers have to the second molars and prolonged wear of self-declare compliance by submitting an OTC splint leaving these teeth uncovered, a dossier but, as mentioned previously, sleep related bruxism, left sided masseteric do not need to submit trial data for their Fig. 2 DPT recorded 3.5 years before hypertrophy and mild left sided myofascial product showing efficacy and safety. In presentation – no step in the occlusal plane pain. At this point the patient was instructed addition, manufacturers must register with is evident to stop wearing the OTC splint immediately the competent authority where they or and use only the soft splint provided by their authorised European representative Whoever makes the report should bear in his dentist. He was also counselled on the is based. In the UK the MHRA also has a mind that this may be a suspected adverse importance of biting together on his second market surveillance and enforcement role. reaction. In other words absolute proof of molars while swallowing but otherwise Under these arrangements manufacturers causation is not expected by the MHRA. to avoid clenching his teeth. In addition, are expected to monitor any reports received On receipt of a report the MHRA will remedial jaw exercises were prescribed to be from healthcare professionals, patients also correspond with the manufacturer and carried out two to three times a day for his or consumers involving their products. if necessary investigate and resolve any TMD symptoms. Following occlusal analysis There are generic guidelines that apply to potential breaches of the regulations that with mounted study casts, arrangements all classes of medical device which inform implement the EC Medical Directive into were made for the unerupted 18 and 28 to manufacturers when to notify the MHRA UK law. This may involve checking that be extracted and after initial settling of the regarding significant events.34 A significant the technical documents the manufacturer occlusion he was successfully fitted with event would be one that ‘led, or might have is required to hold demonstrate conformity a stabilisation splint. Treatment extended led, to death or to a serious deterioration in with the requirements of the Directive. over eight appointments. The occlusion state of health’. With such a high threshold The MHRA therefore need to know about re-interdigitated successfully without it would be unlikely that the MHRA would products being sold without a CE marking. occlusal adjustment and his TMD symptoms receive many reports from manufacturers For readers in other European countries were well controlled. We recommended the of OTC bruxism splints. However, we can who come across problems with OTC splints patient continue to wear his stabilisation see from Table 4 there are several associated details of the relevant competent authorities splint while the sleep bruxism was active. hazards (for example, scalding, choking, may be found at: http://ec.europa.eu/health/ The masseteric hypertrophy will continue to tissue damage, occlusal changes and onset medical-devices/files/list-of-contact-points- be reviewed by the maxillofacial surgeons of TMD significantly impacting on patient’s within-the-national_en.pdf and the occlusion will continue to be quality of life) that the MHRA would expect reviewed by the restorative dentists. manufacturers to report. Advice on reporting issues Recognising the need to identify any with OTC bruxism splints European regulation and reporting emerging safety issues the MHRA encourages Where a dentist, a patient or a consumer problems with OTC bruxism splints healthcare professionals, patients and experiences problems associated with an UK Dentists will be aware of the MHRA consumers to report issues with medical OTC bruxism splint: in relation to prescribing custom made devices using their online reporting tool. • Report the problem both to the MHRA appliances. The MHRA is also the competent In this way they can update their adverse and to the manufacturer authority in the UK in relation to OTC incident database. The MHRA advise that • Dental care professionals should assist bruxism splints. Other countries in the EU some apparently minor incidents may have their patients with reporting have their own competent authorities, which greater significance when aggregated with • There are separate forms for dental have similar arrangements to the MHRA. other similar reports. So, it is better to report care professionals and for patients/ Manufacturers self-certify the risk level of a suspected adverse incident than ignore it. consumers to report issues: http:// their products and, on the basis that bruxism A summary of advice on reporting to the www.mhra.gov.uk/Safetyinformation/ splints should just be worn overnight, the EC MHRA and at the same time to manufacturers Reportingsafetyproblems/Devices/index. Medical Devices Directive agrees with them can be found below. htm being categorised as Class 1 medical device If a patient has had a problem requiring • The OTC splint should be kept by the or ‘low risk’. As the market for medical specialist referral we recommend the dentist or the consumer. The MHRA devices, including OTC bruxism splints, specialist assist with the task of reporting. may require the splint to be examined

and tested. If so they will request for use of custom made full coverage splints is htm?csnumber=62279 (accessed March 2014). 18. Committees of Advertising Practice. Medical the splint to be sent to the manufacturer still recommended unless there are specific devices ‑ advertising advice. CAP, 2013. who will report directly to the MHRA. contra-indications. With any type of bruxism Online advice available at http://www. appliance the importance of regular review cap.org.uk/Advice‑Training‑on‑the‑rules/ Advice on monitoring Advice‑Online‑Database/Medical-devices.aspx is critical. (accessed March 2014). partial coverage splints 19. US Food and Drug Administration. WANTED: We are grateful to the MHRA for their advice If a dentist is aware that a patient is wearing consumers to report problems. Online article regarding the EU regulatory aspects of this article. available at http://www.fda.gov/ForConsumers/ a partial coverage splint (either custom made ConsumerUpdates/ucm354560.htm (accessed 1. Lobbezoo F, Ahlberg J, Glaros A G Bruxism or OTC) it is crucial that he or she monitors et al. March 2014). defined and graded: an international consensus. 20. Dahl B L, Krogstad O. The effect of a partial for unwanted occlusal change. The simplest 2013; 40: 2–4. J Oral Rehabil bite-raising splint on the inclination of upper 2. Lobbezoo F, Ahlberg D, Manfredini D, Winocur E. way of doing this is to record an occlusal and lower front teeth. Acta Odontol Scand 1983; Review article: are bruxism and the bite causally examination before a patient embarks on 41: 311–314. related? J Oral Rehabil 2012; 39: 489–501. 21. Saha S, Summerwill A J. Reviewing the concept of treatment. In this way any changes in shim 3. Carlsson G E, Egermark I, Magnusson T. Predictors of Dahl. Dent Update 2004; 31: 442–444, 446–447. 35 bruxism, other oral parafunctions, and tooth wear stock contacts can be detected at future 22. Poyser N J, Porter R W, Briggs P F, Chana H S, over a 20-year follow-up period. J Orofac Pain 2003; Kelleher M G. The Dahl concept: past, present and appointments. Another excellent method of 17: 50–57. future. Br Dent J 2005; 198: 669–676. recording an archive of occlusal contacts 4. Lobbezoo F, van der Zaag J, van Selms M K, 23. Dincer M, Meral O, Tumer N. The investigation of 36,37 Hamburger H L, Naeije M. Principles for the is to use the occlusal sketch technique. occlusal contacts during the retention period. Angle management of bruxism. J Oral Rehabil 2008; 35: 2003; 73: 640–646. In addition, impressions can be made and 509–523. Orthod 24. Dahl B L, Krogstad O. The effect of a partial bite casts poured as a three-dimensional baseline 5. Moufti M A, Lilico J T, Wassell R W. How to make a raising splint on the occlusal face height. An x‑ray well-fitting stabilization splint. Dent Update 2007; record so that any subsequent changes can cephalometric study in human adults. 34: 398–400, 402–404, 407–408. Acta Odontol be detected visually. We advise prospective 6. Stapelmann H, Turp J C. The NTI-tss device for the Scand 1982; 40: 17–24. monitoring as it allows changes to be picked therapy of bruxism, temporomandibular disorders, 25. Ng J, Major P W, Flores-Mir C. True molar intrusion attained during orthodontic treatment: a systematic up before they become irreversible and both and headache‑ where do we stand? A qualitative systematic review of the literature. BMC Oral Health review. Am J Orthod Dentofacial Orthop 2006; difficult and expensive to treat. Where early 2008; 8: 1–23. 130: 709–714. changes are detected patients can be advised 7. Chate R A, Falconer D T. Dental appliances with 26. Ng J, Major P W, Heo G, Flores-Mir C. True incisor intrusion attained during orthodontic treatment: a either to discontinue use or try a custom inadequate occlusal coverage: a case report. Br Dent J 2011; 210: 109–110. systematic review and meta-analysis. Am J Orthod made full-coverage design. 8. Mobilio N, Catapano S. European Academy of Dentofacial Orthop 2005; 128: 212–219. Unless a dentist prescribes an OTC splint, Craniomandibular Disorders ‑ patient information. 27. Craddock H L, Youngson C C. A study of the European Academy of Craniomandibular Disorders, incidence of overeruption and occlusal interferences or is aware that their patient has started to 2013. Online information available at http://www. in unopposed posterior teeth. Br Dent J 2004; wear a self-prescribed splint, it is hard to eacmd.org/patient.php (accessed March 2014). 196: 341–348. see how baseline records could have been 9. Fricton J, Look J O, Wright E et al. Systematic review 28. Brown D T, Gaudet E L Jr, Phillips C. Changes in and meta-analysis of randomized controlled trials vertical tooth position and face height related to taken of the occlusal condition before splint evaluating intraoral orthopedic appliances for long term anterior repositioning splint therapy. treatment started. Therefore, if problems temporomandibular disorders. J Orofac Pain 2010; Cranio 1994; 12: 19–22. 29. Centre for Evidence Based Medicine. occur a retrospective assessment will be 24: 237–254. Oxford Centre 10. van der Zaag J, Lobbezoo F, Wicks D J, Visscher C M, for Evidence-based Medicine‑ levels of evidence needed. For this purpose we advise study Hamburger H L, Naeije M. Controlled assessment of (March 2009). CEBM, 2009. Online information casts, photographs and radiographs where the efficacy of occlusal stabilization splints on sleep available at http://www.cebm.net/index.aspx?o=1025 (accessed March 2014). clinically justifiable. The photographs should bruxism. J Orofac Pain 2005; 19: 151–158. 11. Nikolopoulou M, Naeije M, Aarab G, Hamburger H L, 30. General Dental Council. Standards for dental highlight changes that appear associated with Visscher C M, Lobbezoo F. The effect of raising the professionals. London: GDC, 2005. the splint wear. It is also worth recording an bite without mandibular protrusion on obstructive 31. General Dental Council. Standards for the dental team. London: GDC, 2013. occlusal examination or occlusal sketch as sleep apnoea. J Oral Rehabil 2011; 38: 643–647. 12. Nikolopoulou M, Ahlberg J, Visscher C M, Hamburger 32. General Medical Council. Good medical practice. mentioned previously. If previous records H L, Naeije M, Lobbezoo F. Effects of occlusal Contribute to and comply with systems to protect exist these should of course be retrieved stabilization splints on obstructive sleep apnea: patients (section 23c). London: GMC, 2013. 33. Lennard N, Coutinho M, Campbell D. The surgeon for comparison. a randomized controlled trial. J Orofac Pain 2013; 27: 199–205. and medical devices: adverse incident reporting 13. Magdaleno F, Ginestal E. Side effects of stabilization and off label use. Ann R Coll Surg Engl 2013; CONCLUSION occlusal splints: a report of three cases and 95: 309–310. literature review. Cranio 2010; 28: 128–135. 34. European Commission, DG Health and Consumer This paper considers the possibility that 14. Okeson J P. The effects of hard and soft occlusal (SANCO). Guidelines on a medical devices vigilance individuals may be bypassing their dentists splints on nocturnal bruxism. J Am Dent Assoc 1987; system. European Comission, 2013 Online guidelines by buying OTC bruxism splints on the 114: 788–791. available at http://ec.europa.eu/health/medical- 15. U S Food and Drug Administration. MAUDE‑ devices/files/meddev/2_12_1_ol_en.pdf (accessed Internet. Dentists need to keep this market Manufacturer and User Facility Device Experience. March 2014). in mind when reviewing patients to check if [Online information available at http://www. 35. Steele J G, Nohl F S, Wassell R W. Crowns and other they are using such appliances, particularly accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/ extra-coronal restorations: occlusal considerations textsearch.cfm (accessed March 2014). and articulator selection. Br Dent J 2002; if there are unexplained occlusal changes or 16. Office of Fair rading.T A short guide for business on 192: 377–380, 383–377. other problems. distance selling. London: OFT, 2008. Online guide 36. Davies S J, Grey R J, Al-Ani M Z, Sloan P, Where problems occur it is good practice to available at http://www.oft.gov.uk/shared_oft/ Worthington H. Inter‑and intra-operator reliability business_leaflets/general/oft913.pdf (accessed of the recording of occlusal contacts using inform the appropriate competent authority, March 2014). ‘occlusal sketch’ acetate technique. Br Dent J 2002; which in the UK is the MHRA. 17. International Organization for Standardization. 193: 397–400. Bruxism is often a long-term problem Dentistry ‑ base polymers ‑ part 2: orthodontic 37. Davies S, Al-Ani Z, Jeremiah H, Winston D, Smith P. base polymers. ISO/FDIS 20795–2:2013. ISO, 2013. Reliability of recording static and dynamic occlusal and because tooth movements are not Online information available at http://www.iso.org/ contact marks using transparent acetate sheet. J considered desirable in its management, the iso/iso_catalogue/catalogue_tc/catalogue_detail. Prosthet Dent 2005; 94: 458–461.