A Pilot Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse
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ClinicalTrials.gov Identifier: NCT04152642 |
Recruitment Status :
Completed
First Posted : November 5, 2019
Results First Posted : February 2, 2021
Last Update Posted : February 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Mouth | Device: Marketed Dry Mouth Rinse Other: Water control Device: Experimental Dry Mouth Rinse | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | 3-treatment crossover, with 4 days of use |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Clinical Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse Compared to a Negative Control |
Actual Study Start Date : | November 4, 2019 |
Actual Primary Completion Date : | December 5, 2019 |
Actual Study Completion Date : | December 5, 2019 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Marketed Mouth Rinse
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.
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Device: Marketed Dry Mouth Rinse
relieves dry mouth symptoms by physically coating oral mucosal surfaces. |
Experimental: Experimental Mouth Rinse
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.
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Device: Experimental Dry Mouth Rinse
relieves dry mouth symptoms by physically coating oral mucosal surfaces. |
Sham Comparator: Water/Negative Control
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.
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Other: Water control
negative control |
- Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4 [ Time Frame: 2-hour, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04152642
United States, Ohio | |
Procter & Gamble | |
Mason, Ohio, United States, 45040 |
Principal Investigator: | Malgorzata Klukowska, DDS | Procter and Gamble |
Documents provided by Procter and Gamble:
Responsible Party: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT04152642 |
Other Study ID Numbers: |
CSD2019138 |
First Posted: | November 5, 2019 Key Record Dates |
Results First Posted: | February 2, 2021 |
Last Update Posted: | February 2, 2021 |
Last Verified: | January 2021 |
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 |
Xerostomia Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases |