Perception of an Experimental Mouthwash in People With Dry Mouth
Objectives: To investigate perception of an experimental mouthwash (MW) compared to water. Methods: A randomized, examiner-blind, single use, crossover study in participants with (n=22) or without (n=33) Sjogren’s syndrome (SS) experiencing dry mouth symptoms. Participants swished with 15 mL of assigned product for 30 seconds then expectorated. They completed a post-product use questionnaire immediately and 30 minutes after use. Primary efficacy was response to the statement ‘This product is gentle’ on a five-item Likert scale. Results: Most participants found both treatments ‘gentle’ though fewer with SS in the MW group agreed with this statement. Immediately and 30 minutes post-use a higher percentage of participants found the MW ‘moisturizing’, ‘soothing’, and ‘refreshing’ than with water. Some felt the MW caused ‘tingling’, ‘numbing’, ‘burning’, and ‘drying out of their mouth’ immediately post-use with all but ‘drying out’ lessening by 30 minutes. One mild, non-oral, treatment-emergent but not treatment-related adverse-event was reported by a MW group participant. Conclusions: Most agreed that the experimental MW was ‘gentle’ with results for those with or without SS generally consistent with those for the overall population. Participants found the MW ‘moisturizing’, ‘soothing’, and ‘refreshing’ up to 30 minutes post-use. Both treatments were generally well-tolerated.
Support Funding Agency/Grant Number: This study was sponsored by GSK Consumer Healthcare.
Financial Interest Disclosure: This study was sponsored by GSK Consumer Healthcare of whom A Jose and R Varghese are employees. ML Singh, A Farag, A Papas, B Magnuson, B Desai, E Tzavaras and N Kafasis are employees of Tufts University, which has received funding from GSK Consumer Heal
SESSION INFORMATION
Poster Session
Pharmacology/Therapeutics/Toxicology II
Friday,
03/23/2018
, 03:45PM - 05:00PM
TABLES
Table 1
SS (n=22)
Non-SS (n=33)
Overall (n=55)
Agree/strongly agree
MW
Water
MW
Water
MW
Water
Number(percent)
15(68.2)
22(100.0)
28(84.8)
27(81.8)
43(78.2)
49(89.1)
95% confidence interval
45.1,86.1
84.6,100.0
68.1,94.0
64.5,93.0
65.0,88.2
77.8,95.9
Response to ‘This product is gentle’
Table 2
MW
Water
Immediately*/30 minutes**
Immediately*/30 minutes**
Moisturizing
94.5%/87.3%
78.2%/50.9%
Soothing
94.5%/83.6%
72.7%/32.7%
Refreshing
94.5%/81.8%
70.9%/25.5%
Tingling
54.5%/16.4%
9.1%/1.8%
Numbing
18.2%/5.5%
1.8%/5.5%
Burning
16.4%/1.8%
0%/3.6%
Drying out
9.1%/16.4%
10.9%/30.9%
‘Yes’ responses to *‘Did you experience any of the following sensations in your mouth?’ immediately following use and **‘Are you experiencing any of the following sensations in your mouth?’ 30 minutes after use (post-hoc analysis)