Due to an FDA Public Health Notice to healthcare providers dated February 14, 2008, we do not recommend commercial denture cleansers be used to maintain your custom mandibular repositioning appliance.
A notice provided by Daniel G. Schultz, MD, Director, Center for Devices and Radiological Health, Food and Drug Administration noted the following:
The FDA has received at least 73 reports of advers effects and one death as a result of allergic reactions to commercial denture cleansers. The adverse effects were not related to improper use. In some cases the allergic reactions took place immediately while other allergic responses were the result of years of use.
It is believed that the component triggering the allergy is persulfate, a known allergen. Persulfate is used in most denture cleansers to clean and bleach the appliance. The most common symptoms included irritation, rash, soft tissue pain, respiratory conditions and hypotension. Some severe adverse reactions have included abdominal pain, vomiting, seizures, hypotension, difficulty breathing and death.
It is critical that commercial denture cleansers containing persulfates should never be ingested. Any time it is used the appliance or prosthetic should be rinsed thoroughly. Ingesting even a small amount of commercial denture cleanser containing persulfates can result in ulcers, hypotension, abdominal pain and vomiting, burns and difficulty breathing.
If you have had an adverse reaction to a denture cleanser containing persulfate please report it directly to the FDA at: 1 (800) FDA-1088.
Homecare Instructions for Thermal Active Appliances such as Herbst and Respire:
Please use cool water only when rinsing the appliance. Store it dry in a well ventilated area.
Please use warm water to soften the material prior to insertion.
Please keep your mandibular repositioning appliance out of reach of pets and away from heat sources.
Please use a soft bristled tooth brush.
Please do not use a commercial denture cleanser or any mouth rinse containing alcohol.
We recommend yearly follow-up appointments.
We recommend using DentaSOAK® as directed by the manufacturer. It requires only 15 minutes, has no persulfates or alcohol and is non-toxic. Although it is a tissue friendly cleaning agent it is clinically proven to destroy candida albicans and other oral microbes. The manufacturer states that it "kills more than 99% of infection-causing bacteria in just 15 minutes". Our office keeps it in stock at all times.