A randomized controlled study to evaluate an experimental moisturizing mouthwash formulation in participants experiencing dry mouth symptoms

Publication date: Available online 30 May 2018
Source:Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
Author(s): Anto Jose, Mabi L. Singh, Britta Magnuson, Arwa Farag, Roshan Varghese, Athena Papas
ObjectiveTo evaluate efficacy and tolerability of an experimental moisturizing mouthwash versus water only in participants experiencing dry mouth symptoms including those with Sjögren's syndrome (SS; n=28).Study designParticipants were randomized to the experimental Mouthwash (n=53) or Water-only (n=47) groups. For 8 days, Mouthwash participants used 1–2 doses/day at home; both groups could sip water as needed. Supervised treatment occurred on Days 1, 3, and 8 where before/after administration participants completed the Product Performance and Attributes Questionnaire (PPAQ) parts 1–4.ResultsSignificant between-treatment differences on all PPAQ questions were shown at most time points. On Day 8, at 120 minutes, there was a significant difference on PPAQ3-Question 1 ('Relieves the discomfort of dry mouth'; the pre-defined primary efficacy variable) in favor of Mouthwash versus Water (0.63 [95% confidence intervals 0.17,1.10]; P = .0084). Sub-group analysis found a significant difference favored Mouthwash in participants without SS (0.67 [0.11,1.23]; P = .0203) but not with SS (0.52 [-0.35,1.38; P = .2272). Eight, non-serious, oral, treatment-related adverse events were reported by the Mouthwash group.ConclusionsThe findings of a subjective questionnaire showed that an experimental moisturizing mouthwash provided greater relief than water only from dry mouth symptoms over 8 days.Clinicaltrials.gov: NCT02641912



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