Christine Bambi Lung1, Gene E Watson2, Swati Verma3, Changyong Feng4, Ralph H Saunders5. 1. Dental Resident and Study Sub-PI, Department of General Dentistry, Department of Pediatric Dentistry, University of Rochester-Eastman Institute for Oral Health, Rochester, NY, USA. Electronic address: christine.lung@utoronto.ca. 2. Professor, Department of Dentistry, Center for Oral Biology, Department of Pharmacology and Physiology, Department of Environmental Medicine, University of Rochester-Eastman Institute for Oral Health, Rochester, NY, USA. 3. Dental Resident, Department of General Dentistry, University of Rochester-Eastman Institute for Oral Health, Rochester, NY, USA. 4. Statistician, Department of Biostatistics and Computational Biology, University of Rochester-Eastman Institute for Oral Health, Rochester, NY, USA. 5. Professor, Faculty, and Study PI, Department of General Dentistry, Eastman Institute for Oral Health, Rochester, NY, USA.
Abstract
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.
RCT Entities:
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.
Authors: Kihoon Nam; Harim T Dos Santos; Frank Maslow; Bryan G Trump; Pedro Lei; Stelios T Andreadis; Olga J Baker Journal: Front Bioeng Biotechnol Date: 2021-09-24