Back to resultsImprovement of Dry Mouth Sufferers After Using an Experimental Dry Mouth Rinse Compared to a Water Control
Primary Purpose
Dry Mouth
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dry mouth rinse
Water Control
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;
- Sign a Confidentiality Disclosure Agree(CDA) form and be given a signed copy;
- Be at least 18 years of age;
- 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 eating, drinking, smoking, using oral care products, using tobacco, using a medicated lozenge, chewing gum, or breath mints during the 6-hour test period (except snack after 4-hour Questionnaire);
- 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;
- 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); or
- Evidence of gross intra-oral neglect or need for extensive dental therapy.
Sites / Locations
- Salus Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Active Comparator
Arm Label
Experimental Mouth Rinse
Water Control
Positive Control
Arm Description
dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.
Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.
dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.
Outcomes
Primary Outcome Measures
Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment
Product Performance and Attributes (PPAQ I)
Since you have been using the product, please rate each of the following at this timepoint: (Select one response for attribute)- excellent=5, very good=4, good=3, fair=2, poor=1:
1) Relieves the discomfort of your dry mouth
Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment
Product Performance and Attributes (PPAQ I)
Since you have been using the product, please rate each of the following at this timepoint: (Select one response for 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
NCT04189081
Brief Title
Improvement of Dry Mouth Sufferers After Using an Experimental Dry Mouth Rinse Compared to a Water Control
Official Title
A Clinical Study to Evaluate Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Water Control
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 13, 2020 (Actual)
Primary Completion Date
July 8, 2020 (Actual)
Study Completion Date
July 8, 2020 (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 study is to evaluate dry mouth relief in subjects with self-reported feeling of dry mouth after using an experimental mouth rinse or a positive control compared to a water control.
Detailed Description
This is a controlled, randomized, 3-treatment, parallel study for subjects with self-reported dry mouth symptoms as determined by an Oral Examination and subject responses to the Dry Mouth Inventory (DMI) questionnaire (see section 12) at the Acclimation visit. Qualified subjects will be randomly assigned to one of three treatments at the Baseline visit. Safety will be assessed by Oral Examinations at Baseline/Day1 and Day 8. Subjects will complete questionnaires before product use, immediately after product use (Day 1 only), and after 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours of product use on Baseline/Day 1 and Day 8. The PPAQ II questionnaire will be completed on the morning of Day 8 (see study schedule for details).
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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.
Arm Title
Water Control
Arm Type
Sham Comparator
Arm Description
Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.
Arm Title
Positive Control
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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7.
Intervention Type
Device
Intervention Name(s)
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
Primary Outcome Measure Information:
Title
Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment
Description
Product Performance and Attributes (PPAQ I)
Since you have been using the product, please rate each of the following at this timepoint: (Select one response for attribute)- excellent=5, very good=4, good=3, fair=2, poor=1:
1) Relieves the discomfort of your dry mouth
Time Frame
4-hours
Title
Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment
Description
Product Performance and Attributes (PPAQ I)
Since you have been using the product, please rate each of the following at this timepoint: (Select one response for attribute)- excellent=5, very good=4, good=3, fair=2, poor=1:
1) Relieves the discomfort of your dry mouth
Time Frame
6-hours
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;
Sign a Confidentiality Disclosure Agree(CDA) form and be given a signed copy;
Be at least 18 years of age;
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 eating, drinking, smoking, using oral care products, using tobacco, using a medicated lozenge, chewing gum, or breath mints during the 6-hour test period (except snack after 4-hour Questionnaire);
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;
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); or
Evidence of gross intra-oral neglect or need for extensive dental therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Milleman, DDS
Organizational Affiliation
Procter and Gamble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salus Research
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improvement of Dry Mouth Sufferers After Using an Experimental Dry Mouth Rinse Compared to a Water Control
We'll reach out to this number within 24 hrs