Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects

A Clinical Study Evaluating the Consumer Perception of an Experimental Mouthwash Formulation After a Single Use

The purpose of this study is to investigate the consumer perception of an experimental mouthwash formulation in population with dry mouth

Study Overview

• Status: Completed
• Conditions: Xerostomia
• Intervention / Treatment: Other: Biotene mouthwash; Other: Bottled mineral water

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
• Aged 18 - 84 years inclusive
• Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination
• Participant reports having a feeling of a dry mouth according to the Dry Mouth Screening Questionnaire (DMSQ) (Subject must answer at least 2 out of the 4 questions with 'agree a little', 'agree' or 'strongly agree' at the Screening Visit (Visit 1). Participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min at the Screening Visit (Visit 1).
• Participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min ATH the Screening Visit (Visit 1).
• Understands and is willing, able and likely to comply with all study procedures and restrictions

Exclusion Criteria:

• Women who are known to be pregnant or who are intending to become pregnant over the duration of the study or have a positive urine pregnancy test at the Screening Visit
• Women who are breast-feeding
• Participant is currently undergoing radiotherapy and/or chemotherapy treatment
• Any condition the investigator identifies that can confound the participant's ability to properly participate in the study e.g. Alzheimer's Disease
• Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration)
• Evidence of gross intra-oral neglect or need for extensive dental therapy
• Denture wearer (complete dentures)
• Participant not on stable doses of prescription systemic parasympathetic medications (e.g. Pilocarpine), for the treatment of the feeling of dry mouth
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 14 days of the screening visit
• Previous participation in this study
• Recent history (within the last 1 year) of alcohol or other substance abuse
• An employee of the sponsor or the clinical study team or members of their immediate family. Students and employees of the Tufts University School of Dental Medicine not associated with the clinical trials team are eligible to participate. Students and employees will not be specifically targeted for enrollment
• Non-English speaking Participants will not be enrolled in the study. Participants must be able to read and write in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Product 1; Participants will rinse their mouth with 15 mL of the product swishing for 30 seconds.	Other: Biotene mouthwash; Participants will rinse their mouth with 15 mL of Biotene mouthwash swishing for 30 seconds.
Other: Test Product 2; Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds. Participants then spit out the water.	Other: Bottled mineral water; Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1	Participants answered the following question, Q1: how much do you agree or disagree with the following statements about this product, having used it? "This product is gentle": disagree strongly, disagree, neither agree nor disagree, agree, or agree strongly. There was no formal statistical hypothesis to be tested for this outcome..	Within 2 minutes post product use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7	Participants answered the following questions, Q3: Which of following statements best describes how much you liked product overall? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 4: Which of the following statements best describes how much you liked overall flavor of rinse? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 5: How you would rate flavor intensity of oral rinse? strongest flavor imaginable, very strong, strong, moderate, weak, barely detectable, no flavor at all. Q 6: Did you experience any of following sensations in your mouth & how strong was sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Participants who selected "None" for a particular sensation, did not complete Q 7 for that sensation: When did you experience sensations in your mouth? initially, during use, or after use.	Within 2 minutes post product use
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)	Participants answered the following question; Q1: Are you experiencing any of the following sensations in your mouth and how strong is the sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Q2: Would you continue use of the product? (Yes or No)	Within 30 ± 5 minutes post product use
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)	Participants rated the following criteria on a scale of 1 to 5(1=Poor, 2= Fair, 3= Good, 4= Very good, 5= Excellent) as follows: 1. Having an immediate dry mouth relief, 2. Having an immediate lubricating effect, 3. Having an immediate moisturizing effect.	Within 5 minutes post product use

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2016
• Primary Completion (Actual): October 19, 2016
• Study Completion (Actual): October 19, 2016

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: December 23, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: May 21, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: 205067