How do you know that the Smilesaver® formulation works as intended?

Microbiological studies using accepted USP standard methods have measured the efficacy of our cleansing and freshening spray. These have included Short Interval Kill Test (SIKT) and Zone of Inhibition (ZOI) tests. In addition, the Preservation Efficacy Test (PET) was used to show that the products were robust to accidental contamination during standard periods of use.

What does Smilesaver® protect against?

The Soluria® products protect against (or eliminate) common bacteria, such as Salmonella typhimurium (sp?), Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumonia, Listeria monocytogenes, Staphylococcus aureus, Methicillin-resistant Staphylococcus aureus, and Streptococcus pyogenes, as well as yeast, Candida albicans, and mold Aspergillus Brasiliensis and Aspergillus Niger.

Why is protection against bacteria necessary?

It is necessary to protect against potentially harmful bacteria in the biofilm that builds up on the surface of removable oral appliances, such as clear aligners, retainers, night guards, and sports mouth guards.

Do the products taste good?

Smilesaver® is available in a great tasting spearmint natural flavor to suit the needs of all users and provide a fresh, minty taste that the users really enjoy.

What lab data do you have to indicate that Smilesaver® works, and how long does it work?

Soluria® has microbiological data that shows that these products reduce bacteria by up to 99.9% after 1 and 3 minutes of treatment. If your device is in contact with the product for longer periods, the product will continue to work.

Mouthguards have been used for years at all levels of contact sports, why is this cleansing and freshening spray now desirable or required?

While the possibility of contamination has been recognized for some time, the connection to getting sick was not recognized by sports officials until recently. Recent research and case studies have indicated that mouthguards can become heavily contaminated and this contamination may be linked to compromised health in certain individuals. General awareness of these issues is now becoming recognized. Smilesaver® is the only available mouthguard cleansing and freshening spray that has FDA approved GRAS (Generally Recognized as Safe) naturally derived ingredients. Commercial oral rinses contain ingredients, such as chlorhexidine, cetylpyridinium chloride, or alcohol. These products have several negatives, such as staining of the teeth or, perhaps, numbing of taste sensation, which is not the case for Smilesaver®.

How often is it best to use Smilesaver®?

Use it as often as necessary! Our sprays are packaged in 30ml containers to promote frequent use while on-the-go.

What if you swallow the solution?

If you swallow some of the spray solution after spraying your appliance, it is safe to ingest based upon the FDA’s safety classification of all of its ingredients as GRAS. The body will readily metabolize the ingredients in Smilesaver®, including the principal active ingredient, LAE, to harmless materials. This principal ingredient has been extensively tested, passing all toxicology studies and, thus, has been found to be safe and effective.

Are there any potential side effects from using Smilesaver® for cleansing oral appliances?

None. All ingredients in the formulations are well below anything that might potentially lead to toxicity. The ingredients are widely used in foods and cosmetics. When used in Soluria® products, as intended, they are free from any reported adverse effects.

Is xylitol a safe ingredient? How do we know?

Xylitol is as sweet as sugar, but with 33% less calories. Cavity-causing bacteria ferment sugar forming acids which demineralize tooth enamel which can lead to cavities. However, they do not ferment xylitol, so it is an effective sweetener which is safe for the teeth. Xylitol can also prevent bacterial adhesion to the tooth surfaces, preventing biofilm formation and so it can be beneficial to dental health: chewing gum with xylitol and toothpastes with xylitol have been clinically proven to reduce cavities by reducing demineralization and increase re-mineralization of weakened tooth enamel. Xylitol has no aftertaste and is safe for diabetics and individuals with hyperglycemia. Xylitol has no known toxicity or carcinogenicity and is considered GRAS by the FDA. Xylitol has also been approved as a food additive for foods for individuals with special dietary needs.

Is Smilesaver® produced in a safe and clean place with all the controls for good manufacturing practice (GMP)?

Our manufacturing facility is ISO certified and Kosher certified. It is FDA approved, having passed all FDA audits as a result of stringent adherence to ISO manufacturing standards. The manufacturer carries the MSDS sheets for all the raw materials in these cleansing and freshening sprays.