A newly published study in the October 2010 issue of The Journal of the American Dental Association (JADA), conducted at New York University's College of Dentistry, confirms the safety and efficacy of a new novel method for controlling xerostomia, or dry mouth. The double masked, randomized controlled crossover study concludes that use of a unique mucoadhesive patch, affixed to the hard palate inside the mouth, provides statistically significant and sustainable improvements in salivary flow rates and subjective moistness for dry mouth sufferers. An estimated 30 million Americans deal with this uncomfortable oral health condition.
This latest study comes on the heels of another published study (March 2010 issue of Quintessence International) that showed these patches provided better performance for dry mouth sufferers than a leading over-the-counter dry mouth spray.
Chronic dry mouth is an under-diagnosed condition that can have a detrimental effect on oral health by contributing to tooth decay, gum disease and chronic bad breath. It can be a symptom of other medical conditions, such as diabetes or Sjogren's Syndrome, and is also the result of radiation treatment for head and neck cancer, but it is most often a side effect of many prescription and over-the-counter medications taken daily by millions of Americans (34% of people on three or more medications will likely have this condition).
The mucoadhesive patches tested in the study are available to consumers under the brand name OraMoist™ and sold over-the-counter at retailers, such as Rite-Aid and Walgreen's, nationwide. Approximately one centimeter in diameter, the patches can adhere to any oral mucosal surface, such as the roof of the mouth or inside the cheek, and the study confirmed can yield a "statistically significant improvement in baseline subjective and objective measures of dry mouth for up to 60 minutes – and possibly longer – after application."
The JADA study also found that after two weeks of daily use, participants experienced a statistically significant improvement in baseline subjective and objective measures of salivary flow. This, according to the researchers, suggests a sustained effect.
"One of the results was that after two weeks of use of the patch, the amount of saliva in the mouth had increased even during times when there was no patch in the mouth," says the study's lead author A. Ross Kerr, DDS, MSD, clinical associate professor at New York University College of Dentistry. "In other words, the patch would seem to have a cumulative beneficial effect."
According to Dr. Kerr, OraMoist provides an appealing and convenient alternative to other dry mouth treatments, which are usually in spray, rinse or gel form and require the user to replenish when necessary – which can be up to every 20 minutes. Overnight, the sustained effect is of particular benefit.
"The OraMoist patches offer pleasant tasting and longer-lasting option for the management of dry mouth, which becomes a quality of life issue for sufferers," says Dr. Kerr. In this and the Quintessence International study, approximately 70% of participants stated they would use the patch again.
OraMoist Dry Mouth Patch is a time-released mucoadhesive patch that moistens and lubricates the mouth, while simultaneously stimulating saliva production, day or night. . The patch can last for up to four hours and is the only such sustained release dry mouth product available over-the-counter.
The placebo mucoadhesive patches used in this study were made using the same unique, patented technology as the OraMoist patches. Unlike the unloaded placebo patch, the loaded patch, OraMoist, is enhanced by natural ingredients including natural lipids, oral enzymes, citrus oil, sea salt, calcium carbonate, natural lemon and xylitol. According to the company, the researchers behind the patch believe that these additional ingredients also play a role in inhibiting bacterial growth and promoting oral health. Based on the results of this study, further investigation of these benefits is warranted.
The patented mucoadhesive patch technology was developed by Professor Abraham J. Domb, PhD, Institute of Drug Research, School of Pharmacy, Faculty of Medicine at the Hebrew University. Dr. Domb is a leading worldwide authority on mucoadhesive technology/bio-degradable polymer research. The same patch technology has also been successfully adapted for the treatment of aphtous ulcers, or canker sores.
JADA Study Findings Summary: Use of Mucoadhesive Patch for Relief of Chronic Dry Mouth
Significant increase in objectively-measured salivary flow rates in those using OraMoist
A "sustained effect" for OraMoist – the patients using it benefited more on their 4th and 5th weeks than on their 3rd; increased baseline of improvement
96% of patients said OraMoist was easy to use; 82% said OraMoist did not interfere with eating or talking; 74% said the flavor was pleasant.
OraMoist is safe. There were no adverse events reported in the study.