Over-the-counter (OTC) bruxism splints available on the Internet.

Area of Science:

• Dental Science
• Medical Device Regulation

Background:

• Individuals increasingly self-treat bruxism using internet-purchased over-the-counter (OTC) splints.
• This trend bypasses professional dental care, raising concerns about efficacy and safety.
• Unevidenced claims of effectiveness are prevalent in the online market for these devices.

Purpose of the Study:

• To survey OTC bruxism splints available in the UK via the internet.
• To categorize their characteristics, including claims and safety warnings.
• To assess compliance with medical device directives.

Main Methods:

• Conducted an internet search for OTC bruxism splints available in the UK.
• Recorded manufacturer, device name, price, claims, and safety warnings from retail websites.
• Checked for CE marking indicating compliance with EC Medical Devices Directive.

Main Results:

• Safety information was notably scarce online; many sites lacked any warnings.
• The MAUDE database revealed serious adverse events: choking hazards, tissue damage, occlusal changes.
• None of the surveyed splint designs offered full occlusal coverage.

Conclusions:

• Partial coverage OTC splints may cause unwanted tooth movement with prolonged use.
• Dentists are urged to report suspected adverse events from OTC splints to the MHRA.
• Patient self-treatment with OTC bruxism splints carries potential risks.