Dry Mouth
Conditions
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).
Interventions
DEVICEdry mouth rinse
relieves dry mouth symptoms by physically coating oral mucosal surfaces.
OTHERWater Control
negative control
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to Relieving the Discomfort of Dry Mouth From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment | 4-hours | 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 |
Countries
United States
Participant flow
Recruitment details
Self-reported a dry mouth feeling according to the modified DMI questions (Subject must have answered at least 2 out of 4 questions below with 'agree a little,' 'agree' or 'strongly agree'): How much do you agree or disagree that you experience the following? (strongly disagree, disagree, disagree a little, agree a little, agree, strongly agree) 1. No moisture in the mouth 2. Lips sticking to teeth 3. Tongue sticking to roof of mouth 4. Throat feels dry
Participants by arm
| Arm | Count |
|---|---|
| Water Control 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.
Water Control: negative control | 46 |
| Experimental Mouth Rinse 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.
dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces. | 45 |
| Positive Control 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.
dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces. | 46 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Water Control | Experimental Mouth Rinse | Positive Control | Total |
|---|---|---|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 11.83 | 56.2 years STANDARD_DEVIATION 14.97 | 58.3 years STANDARD_DEVIATION 12.04 | 57.6 years STANDARD_DEVIATION 12.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 44 Participants | 46 Participants | 135 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 12 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 41 Participants | 38 Participants | 33 Participants | 112 Participants |
| Sex: Female, Male Female | 39 Participants | 37 Participants | 37 Participants | 113 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 9 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 45 | 0 / 46 |
| other Total, other adverse events | 3 / 46 | 2 / 45 | 2 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 45 | 0 / 46 |
Outcome results
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
Time frame: 4-hours
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Water Control | Response to Relieving the Discomfort of Dry Mouth From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment | 2.51 score on a scale | Standard Error 0.158 |
| Experimental Mouth Rinse | Response to Relieving the Discomfort of Dry Mouth From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment | 3.26 score on a scale | Standard Error 0.16 |
| Positive Control | Response to Relieving the Discomfort of Dry Mouth From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment | 3.43 score on a scale | Standard Error 0.158 |
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
Time frame: 6-hours
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Water Control | Response to Relieving the Discomfort of Dry Mouth From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment | 2.70 score on a scale | Standard Error 0.154 |
| Experimental Mouth Rinse | Response to Relieving the Discomfort of Dry Mouth From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment | 3.46 score on a scale | Standard Error 0.156 |
| Positive Control | Response to Relieving the Discomfort of Dry Mouth From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment | 3.36 score on a scale | Standard Error 0.154 |