Dry Mouth
Conditions
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.
Interventions
DEVICEMarketed Dry Mouth Rinse
relieves dry mouth symptoms by physically coating oral mucosal surfaces.
OTHERWater control
negative control
DEVICEExperimental Dry Mouth Rinse
relieves dry mouth symptoms by physically coating oral mucosal surfaces.
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
3-treatment crossover, with 4 days of use
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4 | 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 |
Countries
United States
Participant flow
Pre-assignment details
Subjects that qualified were randomized to one of six treatment sequences: ABC, ACB, BCA, BAC, CAB, or CBA. Subjects had at least a 3 day washout before Period 1 and in-between each period.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study single-center, randomized 3-treatment, 3-period crossover study | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 11.96 |
| Dry Mouth Inventory Lips sticking to teeth Agree a Little, Agree, or Strongly Agree | 18 Participants |
| Dry Mouth Inventory Lips sticking to teeth Disagree a Little, Disagree, or Strongly Disagree | 4 Participants |
| Dry Mouth Inventory No moisture in the mouth Agree a Little, Agree, or Strongly Agree | 19 Participants |
| Dry Mouth Inventory No moisture in the mouth Disagree a Little, Disagree, or Strongly Disagree | 3 Participants |
| Dry Mouth Inventory Throat feels dry Agree a Little, Agree, or Strongly Agree | 22 Participants |
| Dry Mouth Inventory Throat feels dry Disagree a Little, Disagree, or Strongly Disagree | 0 Participants |
| Dry Mouth Inventory Tongue sticking to roof of mouth Agree a Little, Agree, or Strongly Agree | 13 Participants |
| Dry Mouth Inventory Tongue sticking to roof of mouth Disagree a Little, Disagree, or Strongly Disagree | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 5 / 20 | 3 / 19 | 2 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 | 0 / 19 |
Outcome results
Primary
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
Time frame: 2-hour, Day 4
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Water/Negative Control | Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4 | 1.79 units on a scale | Standard Error 0.197 |
| Marketed Mouth Rinse | Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4 | 2.97 units on a scale | Standard Error 0.204 |
| Experimental Mouth Rinse | Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4 | 3.33 units on a scale | Standard Error 0.203 |