Back to resultsConsumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects
Primary Purpose
Xerostomia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biotene mouthwash
Bottled mineral water
Sponsored by
About this trial
This is an interventional other trial for Xerostomia
Eligibility Criteria
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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Test Product 1
Test Product 2
Arm Description
Participants will rinse their mouth with 15 mL of the product swishing for 30 seconds.
Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds. Participants then spit out the water.
Outcomes
Primary Outcome Measures
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..
Secondary Outcome Measures
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.
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03005041
Brief Title
Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects
Official Title
A Clinical Study Evaluating the Consumer Perception of an Experimental Mouthwash Formulation After a Single Use
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 31, 2016 (Actual)
Primary Completion Date
October 19, 2016 (Actual)
Study Completion Date
October 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the consumer perception of an experimental mouthwash formulation in population with dry mouth
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Product 1
Arm Type
Experimental
Arm Description
Participants will rinse their mouth with 15 mL of the product swishing for 30 seconds.
Arm Title
Test Product 2
Arm Type
Other
Arm Description
Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds. Participants then spit out the water.
Intervention Type
Other
Intervention Name(s)
Biotene mouthwash
Intervention Description
Participants will rinse their mouth with 15 mL of Biotene mouthwash swishing for 30 seconds.
Intervention Type
Other
Intervention Name(s)
Bottled mineral water
Intervention Description
Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds.
Primary Outcome Measure Information:
Title
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1
Description
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..
Time Frame
Within 2 minutes post product use
Secondary Outcome Measure Information:
Title
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Description
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.
Time Frame
Within 2 minutes post product use
Title
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Description
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)
Time Frame
Within 30 ± 5 minutes post product use
Title
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Description
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.
Time Frame
Within 5 minutes post product use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
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Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects
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