Duration of effect of Biotène spray in patients with symptomatic dry mouth: A pilot study.

OBJECTIVES

The objective of this study was to assess the duration of effect of a single dose of Biotène Moisturizing Spray on xerostomia compared to water spray.

STUDY

DESIGN

This double-blind randomized controlled crossover trial compared the duration of effect of 2 agents on relieving xerostomia in adult patients recruited through convenience sampling. Following a xerostomia questionnaire, qualifying patients with an unstimulated whole saliva flow rate of ≤0.20 mL/min rated their baseline level of discomfort from oral dryness and received a single dose (3 sprays) of Biotène Moisturizing Spray or water (active control). Patients indicated their level of oral discomfort every 15 min and the precise time when relief ceased. After a minimum 48-h washout, patients repeated the exercise with the alternative product.

RESULTS

The baseline severity of discomfort from oral dryness among qualifying patients was significantly related to their level of hyposalivation (P = .001). The mean duration of effect of Biotène Moisturizing Spray was 27 ± 25 min, which was not significantly different from that for water (26 ± 25 min; P = .88; n = 25).

CONCLUSION

Biotène Moisturizing Spray and water spray had variable durations of effect averaging approximately 30 min. The results of this pilot study provide guidance regarding anticipated usage and dispensing needs for patients with objective xerostomia. ClinicalTrials.gov NCT03663231.