iMedPub Journals www.imedpub.com 2018 Vol.2 No.2:5 Research Article Journal of Oral Medicine 1 © Under License of Creative Commons Attribution 3.0 License | This article is available in: http://www.imedpub.com/journal-oral-medicine/ Varghese R 1 *, Jose A 1 , Singh ML 2 , Magnuson B 2 , Farag A 2,3 , Kafasis N 2 , Tzavaras E 2 and Papas A 2 1 GSK Consumer Healthcare, Weybridge, Surrey, UK 2 Tufs University School of Dental Medicine, Boston, MA, USA 3 Department of Oral Diagnostc Sciences, King Abdul Aziz University Faculty of Dentstry, Jeddah, Saudi Arabia *Corresponding author: Dr. Roshan Varghese  roshan.x.varghese@gsk.com GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, KT13 0DE, UK. Tel: +44 1932 826 954 Citation: Varghese R, Jose A, Singh ML, Magnuson B, Farag A, et al. (2018) Sensory Percepton of an Experimental Mouthwash for Dry Mouth Symptoms: Two Randomized Clinical Studies. J Ora Med Vol.2 No.2:5 Sensory Percepton of an Experimental Mouthwash for Dry Mouth Symptoms: Two Randomized Clinical Studies Abstract Title: Sensory percepton of an experimental mouthwash for dry mouth symptoms: two randomized clinical studies. Background: A dry mouth accompanied by salivary hypofuncton can negatvely afect mastcaton, deglutton and speaking and can contribute to dental erosion, caries, halitosis and periodontts. Oral mucosal surfaces consequently become desiccated, friable, and more susceptble to abrasion so it’s essental that any treatment used by a person with dry mouth is gentle on the oral mucosa. Here, two randomized, examiner-blind studies utlized questonnaires to assess sensory percepton of an experimental mouthwash in partcipants experiencing dry mouth, some with Sjögren’s syndrome (SS), in comparison to water. Methods and fndings: In Study 1 (single-dose, crossover), partcipants rinsed with 15 mL mouthwash or water for 30-seconds. The primary efcacy variable was post-product use response to ‘This product is gentle’ (fve-item Likert scale). In Study 2 (8-day, parallel-group), partcipants rinsed 1–2x/day at home with 15 mL mouthwash for 30 seconds or used water as required. Supervised administraton (15 mL of assigned product for 30 seconds) was carried out on Days 1, 3, and 8, followed by completon of a four-queston sensory questonnaire (secondary variables). In Study 1 (n=55), most partcipants agreed/strongly agreed that mouthwash (78.2%) and water (89.1%) were gentle (similar results for SS/non- SS partcipants). In Study 2 (n=100), at Day 8 there were no between-treatment diferences in overall likability or favor pleasantness. Signifcant diferences were found in favor of the mouthwash for freshness (0.89[95% CI 0.46, 1.33]) and in favor of water for gentleness (-0.57[-1.03, -0.11]). There were no treatment- related adverse events in Study 1 and eight mild-moderate adverse events with the mouthwash in Study 2. Conclusions: Partcipants with dry mouth with/without SS perceived likability and favor pleasantness of the experimental mouthwash to be similar to water, with diferences in perceived freshness and gentleness. This mouthwash may therefore be suitable for use by people experiencing dry mouth. Keywords: Dry mouth; Gentleness; Moisturizaton; Mouthwashes; Sjögren’s syndrome, Water Abbreviatons: AE: Adverse Event; ANCOVA: Analysis of Covariance; ANOVA: Analysis of Variance; CPC: Cetylpyridinium Chloride; ITT: Intent-to-Treat; OHT: Oral Hard Tissue; OST: Oral Sof Tissue; PP: Per Protocol; PPUQ: Post-Product Use Questonnaire; PPUSQ: Post-Product Use Sensory Questonnaire; PPAQ: Product Performance Atribute Questonnaire; SD: Standard Deviaton; SS: Sjögren’s Syndrome; TEAE: Treatment-Emergent AE; VAS: Visual Analogue Scale Received: April 19, 2018; Accepted: April 26, 2018; Published: May 02, 2018