Dry Mouth Clinical Trial
Official title:
A Clinical Study to Evaluate Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Water Control
NCT number | NCT04189081 |
Other study ID # | CSD2019158 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 13, 2020 |
Est. completion date | July 8, 2020 |
Verified date | May 2021 |
Source | Procter and Gamble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 137 |
Est. completion date | July 8, 2020 |
Est. primary completion date | July 8, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Salus Research | Fort Wayne | Indiana |
Lead Sponsor | Collaborator |
---|---|
Procter and Gamble |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
4-hours | |
Primary | 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 |
6-hours |
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