Back to resultsA Pilot Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse
Primary Purpose
Dry Mouth
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Marketed Dry Mouth Rinse
Water control
Experimental Dry Mouth Rinse
Sponsored by
About this trial
This is an interventional treatment trial for Dry Mouth
Eligibility Criteria
Inclusion Criteria:
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- Be at least 18 years of age;
- Be in good general health as determined by the Investigator/designee;
- Agree not to participate in any other oral care studies for the duration of this study;
- Agree to delay elective dentistry, including dental prophylaxis, until study completion, and to report any non-study dentistry received during the course of the study;
- Agree to refrain from the use of any non-study oral hygiene products for the study duration including mouth rinse and toothpaste (flossing is permitted if part of their normal routine);
- Self-report a dry mouth feeling according to the modified DMI questions. (Subject must answer at least 2 out of 4 questions with 'agree a little,' 'agree' or 'strongly agree');
- Agree to refrain from smoking, drinking, using tobacco products, using breath mints, medicated lozenges, or chewing gum during the 4-hour test period;
- Agree to return for all scheduled visits and to follow all study procedures.
Exclusion Criteria:
- Any condition or disease, as determined by the Investigator/Designee, that could be expected to interfere with examination procedures, with compliance, or with the subject's safe completion of the study;
- Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- Active treatment for periodontitis;
- Having a history of allergies or hypersensitivity to mouth rinse or ingredients in commercial dental products or cosmetics;
- Self-reported pregnancy or the intent to become pregnant during the study, or breast feeding;
- Full or partial dentures or any orthodontic appliances such as braces or aligners, or tongue or mouth piercing;
- Having diabetes;
- Inability to undergo any study procedure;
- Having untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g., current oral ulceration);
- Use of prescription systemic parasympathetic medications (e.g., Pilocarpine), for the treatment of the feeling of dry mouth;
- Currently under the care of a dental/medical professional specifically for the treatment of dry mouth (at the discretion of the Investigator/Designee);
- Self-reported mouth breathers (i.e., mouth breathing secondary to nasal obstruction);
- Evidence of gross intra-oral neglect or need for extensive dental therapy; or
- Currently undergoing radiotherapy and/or chemotherapy treatment.
Sites / Locations
- Procter & Gamble
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Sham Comparator
Arm Label
Marketed Mouth Rinse
Experimental Mouth Rinse
Water/Negative Control
Arm Description
dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.
dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.
subjects will swallow 15 ml of water (on-site). Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after water intake (on-site) on Day 1 and Day 4.
Outcomes
Primary Outcome Measures
Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4
Product Performance and Attributes (PPAQ I) Question #1:
Since you have been used the product, please rate each of the following at this timepoint: (Select one response for each attribute)- excellent=5, very good=4, good=3, fair=2, poor=1:
1) Relieves the discomfort of your dry mouth
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04152642
Brief Title
A Pilot Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse
Official Title
A Pilot Clinical Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Negative Control
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
December 5, 2019 (Actual)
Study Completion Date
December 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The objective of this pilot study is to determine if an experimental mouth rinse and a marketed dry mouth rinse are more effective in relieving dry mouth compared to water.
Detailed Description
This is a controlled, randomized, 3-treatment, 3-period crossover study in subjects with self-reported dry mouth symptoms as determined by subject responses (as determined by the response to "relieving the discomfort of dry mouth" question from the modified Product Performance and Attributes Questionnaire I/ Moisturization and Dryness (PPAQ I/ MD)) compared to water. Subjects enrollment is based on the responses to the Dry Mouth Inventory (DMI). A sufficient number of volunteers will be screened to ensure enrollment of up to 30 subjects at Acclimation. Subjects who meet the eligibility criteria will continue into the treatment phase of the study. Safety will be assessed by Oral examinations at Baseline/Day1 and Day 4. Subjects will complete questionnaires at Baseline (before product use Day 1 only), after immediate use, 30 minutes, 1 hour, 2 hours, and 4 hours after supervised product use on Day 1 and Day 4 of each period. The PPAQ II questionnaire will be completed in the morning of Day 4 of each period. Subjects will be randomly assigned to treatment sequences at the Baseline visit of Period 1. The treatment and washout periods will be repeated until all three treatment periods have been completed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Mouth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
3-treatment crossover, with 4 days of use
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Marketed Mouth Rinse
Arm Type
Active Comparator
Arm Description
dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.
Arm Title
Experimental Mouth Rinse
Arm Type
Experimental
Arm Description
dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.
Arm Title
Water/Negative Control
Arm Type
Sham Comparator
Arm Description
subjects will swallow 15 ml of water (on-site). Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after water intake (on-site) on Day 1 and Day 4.
Intervention Type
Device
Intervention Name(s)
Marketed Dry Mouth Rinse
Intervention Description
relieves dry mouth symptoms by physically coating oral mucosal surfaces.
Intervention Type
Other
Intervention Name(s)
Water control
Intervention Description
negative control
Intervention Type
Device
Intervention Name(s)
Experimental Dry Mouth Rinse
Intervention Description
relieves dry mouth symptoms by physically coating oral mucosal surfaces.
Primary Outcome Measure Information:
Title
Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4
Description
Product Performance and Attributes (PPAQ I) Question #1:
Since you have been used the product, please rate each of the following at this timepoint: (Select one response for each attribute)- excellent=5, very good=4, good=3, fair=2, poor=1:
1) Relieves the discomfort of your dry mouth
Time Frame
2-hour, Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
Be at least 18 years of age;
Be in good general health as determined by the Investigator/designee;
Agree not to participate in any other oral care studies for the duration of this study;
Agree to delay elective dentistry, including dental prophylaxis, until study completion, and to report any non-study dentistry received during the course of the study;
Agree to refrain from the use of any non-study oral hygiene products for the study duration including mouth rinse and toothpaste (flossing is permitted if part of their normal routine);
Self-report a dry mouth feeling according to the modified DMI questions. (Subject must answer at least 2 out of 4 questions with 'agree a little,' 'agree' or 'strongly agree');
Agree to refrain from smoking, drinking, using tobacco products, using breath mints, medicated lozenges, or chewing gum during the 4-hour test period;
Agree to return for all scheduled visits and to follow all study procedures.
Exclusion Criteria:
Any condition or disease, as determined by the Investigator/Designee, that could be expected to interfere with examination procedures, with compliance, or with the subject's safe completion of the study;
Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
Active treatment for periodontitis;
Having a history of allergies or hypersensitivity to mouth rinse or ingredients in commercial dental products or cosmetics;
Self-reported pregnancy or the intent to become pregnant during the study, or breast feeding;
Full or partial dentures or any orthodontic appliances such as braces or aligners, or tongue or mouth piercing;
Having diabetes;
Inability to undergo any study procedure;
Having untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g., current oral ulceration);
Use of prescription systemic parasympathetic medications (e.g., Pilocarpine), for the treatment of the feeling of dry mouth;
Currently under the care of a dental/medical professional specifically for the treatment of dry mouth (at the discretion of the Investigator/Designee);
Self-reported mouth breathers (i.e., mouth breathing secondary to nasal obstruction);
Evidence of gross intra-oral neglect or need for extensive dental therapy; or
Currently undergoing radiotherapy and/or chemotherapy treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malgorzata Klukowska, DDS
Organizational Affiliation
Procter and Gamble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Procter & Gamble
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
12. IPD Sharing Statement
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A Pilot Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse
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