Clinical Studies

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CLINICAL EVALUATION OF THE EFFICACY OF HYALURONAN FORMULATION FOR DRY MOUTH WITH SLEEP APNEA PATIENTS

This cross-over group, randomized, single center, study will enroll subjects to evaluate the safety and efficacy of an HA formulation in people suffering from dry mouth due to CPAP therapy. Subjects from the sleep clinic of Veterans Affairs Medical Center in Buffalo, NY will be recruited under the IRB approved study. Patients will be included in this study when one or more of the symptoms of dry mouth of moderate to severe nature is present.  The duration of the study is 9 weeks and at the end of each treatment day, week and study, the participants will be asked to answer survey questions pertaining to the use of the test sprays. Adverse experiences will be noted and recorded during the study. Study is ongoing and enrollment is open.

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DETERMINATION OF THE SAFETY AND EFFECTIVENESS OF AN ORAL RINSE IN THE REDUCTION OF MEDICATION-ASSOCIATED METALLIC TASTE

The primary intent of this ongoing study is to determine the effectiveness of the oral rinse in reducing the metallic taste in the mouth associated with various reasons, including chemotherapeutic agents. This is a randomized, double-blind, parallel design study with a placebo as the control. The duration of the study will be 1 month. Oral examinations will be done during the study visits. Also at these visits, subjects will be asked about their relief obtained from the medication-associated metallic taste in their mouth and the degree of relief of metallic taste. They will also be asked about the taste and consistency of the mouth rinse. Gingival health will be measured using the Modified Gingival Index (MGI). Safety of the study drug will be monitored through oral soft tissue examinations, including an evaluation of gingival health, tooth and restoration surfaces, and adverse event reporting. The primary response variable will be the relief from medication-associated metallic taste. Study enrollment is open.