CLINICAL EVALUATION OF THE EFFICACY OF AN INTRA ORAL RINSE FOR PATIENTS WITH XEROSTOMIA
This study enrolls adults who are experiencing dry mouth due to medications. The purpose of this study is to learn if a mouthrinse works to help the of symptoms of dry mouth (Xerostomia).
You will use a mouthrinse for two weeks. You will be randomly selected (like drawing a number from a hat) to use either the study mouthrinse, another available mouthrinse sold in stores, or a placebo mouthrinse. Patients will have a screening exam to see if they are eligible. For patients who meet the study criteria, the screening visit may be on the same day as the first study visit. After the screening exam, patients will be in the study for a total of 8 weeks.
This is a randomized double-blind placebo controlled crossover study. The two primary objectives are: (1) to evaluate patients' perception of efficacy of a newly marketed mouthrinse (Hydral) for xerostomia compared to a placebo mouthrinse and another marketed mouthrinse (Biotene) in reducing the symptoms of xerostomia and (2) to determine the efficacies on dry mouth relief and on the patient's Quality of Life. Secondary objectives are (1) to objectively evaluate the improvement of dry mouth symptoms by Hydral compared to the placebo and Biotene, (2) To evaluate the safety of the test mouthrinse on teeth and oral soft tissues, and (3) to evaluate the patient's preferences relative to the test mouthrinses. Basically it is a randomiized cross over study with 39 patients divided into 3 groups. Patients will be screened for eligibility and those accepted will use the product for 2 weeks followed by a 1 week washout period and will then be assigned the next product for 2 weeks use followed by a 1 week washout period, and then assigned the 3rd product for 1 week usage. The product being tested is a mouthrinse (Hydral) made by Sunstar and being sold in the US as well as other parts of the world.
Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Adults ages 18-80.
Have at least 20 natural or restored teeth.
Have a complaint of medication induced dry mouth.
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