Dry Mouth, Xerostomia.Hyaluronic Acid, Xylitol Clinical Trial
Official title:
CLINICAL EVALUATION OF THE EFFICACY OF AN INTRA ORAL SPRAY FOR PATIENTS WITH XEROSTOMIA
This cross-over group, double-blind, randomized, single center, study will enroll 26 subjects to target at least 24 subjects completing the study.Following an initial 3-5 minute evaluation of resting salivary flow, subjects will wait 10 minutes and then use their assigned spray. They will then swallow, and unstimulated saliva will be collected for 3-5 minutes. They will then remain in the study center for 60 min to evaluate xerostomia relief by questionnaire at 5, 15, 30, 45 and 60 min. after the use of mouth spray. They will then be given their assigned product to use twice daily for one week. Subjects will maintain a daily diary of their use of the mouth spray and any oral effects they experience, and will answer all diary questions. Compliance will be assessed by subject diary and measurement of remaining test mouth spray in bottle when unused portion is returned to the clinic. Subjects will also receive 2 questionnaires to complete during the office visit at the end of each 7-day study period. After a 1 week washout, subjects will return to the office to begin the second period of the study, using the same study procedures and be assigned the alternate treatment mouth spray.
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