R W Wassell1, L Verhees1, K Lawrence1, S Davies2, F Lobbezoo3. 1. Department of Restorative Dentistry, The School of Dental Sciences, Framlington Place, Newcastle upon Tyne, NE2 4BW. 2. TMD Clinic, Dental School, Higher Cambridge Street, Manchester, M15 6FH. 3. Department of Oral Kinesiology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and VU University Amsterdam, MOVE Research Institute Amsterdam, Amsterdam, The Netherlands.
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).
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).
Authors: James Fricton; John O Look; Edward Wright; Francisco G P Alencar; Hong Chen; Maureen Lang; Wei Ouyang; Ana Miriam Velly Journal: J Orofac Pain Date: 2010
Authors: Philip Riley; Anne-Marie Glenny; Helen V Worthington; Elisabet Jacobsen; Clare Robertson; Justin Durham; Stephen Davies; Helen Petersen; Dwayne Boyers Journal: Health Technol Assess Date: 2020-02 Impact factor: 4.014