Efficacy of an Intra Oral Spray for Patients With Xerostomia

Objectives: Xerostomia is caused by a variety of conditions, most commonly medications. While many oral sprays are available, there is a need for an oral care product that recapitulates the consistency of saliva. Our aim was to evaluate the effectiveness of a new mouth spray formulated to mimic saliva in reducing the symptoms of xerostomia.
Methods: We conducted a cross-over group, double-blind, randomized, single center study. Individuals who fulfilled the enrollment criteria were recruited based on subjective complaints of xerostomia and objective evaluation. All study subjects had an unstimulated salivary flow rate of < 0.25 milliliters/minute (n = 26). Subjects were assigned to either the control or experimental group and instructed to use the assigned product for one week. After a 1-week washout, patients received the alternate treatment. Subjects completed questionnaires at the end of each study period. Oral examinations were conducted at each visit.
Results: Most patients completed the study (n = 23). Subjects preferred the experimental spray for lubrication (p = 0.0155), comfort (p = 0.0154) and relief of symptoms of xerostomia (p = 0.0297). No serious adverse events occurred.
Conclusions: The test agent met the primary study objective, as patients reported improved oral lubrication. Our preliminary data suggest the oral spray we developed is safe and effective.