Trial Outcomes & Findings for A Pilot Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse (NCT NCT04152642)
NCT ID: NCT04152642
Last Updated: 2021-02-02
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
2-hour, Day 4
Results posted on
2021-02-02
Participant Flow
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.
Participant milestones
| Measure |
Overall Study
Single-center, randomized 3-treatment, 3-periods cross-over study.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
C (Water/Negative) Control
|
20
|
|
Overall Study
A (Marketed Rinse)
|
19
|
|
Overall Study
B (Experimental Rinse)
|
19
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study to Assess Dry Mouth Relief After Using an Experimental Mouth Rinse
Baseline characteristics by cohort
| Measure |
Overall Study
n=22 Participants
single-center, randomized 3-treatment, 3-period crossover study
|
|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 11.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Dry Mouth Inventory
No moisture in the mouth · Agree a Little, Agree, or Strongly Agree
|
19 Participants
n=5 Participants
|
|
Dry Mouth Inventory
No moisture in the mouth · Disagree a Little, Disagree, or Strongly Disagree
|
3 Participants
n=5 Participants
|
|
Dry Mouth Inventory
Lips sticking to teeth · Agree a Little, Agree, or Strongly Agree
|
18 Participants
n=5 Participants
|
|
Dry Mouth Inventory
Lips sticking to teeth · Disagree a Little, Disagree, or Strongly Disagree
|
4 Participants
n=5 Participants
|
|
Dry Mouth Inventory
Tongue sticking to roof of mouth · Agree a Little, Agree, or Strongly Agree
|
13 Participants
n=5 Participants
|
|
Dry Mouth Inventory
Tongue sticking to roof of mouth · Disagree a Little, Disagree, or Strongly Disagree
|
9 Participants
n=5 Participants
|
|
Dry Mouth Inventory
Throat feels dry · Agree a Little, Agree, or Strongly Agree
|
22 Participants
n=5 Participants
|
|
Dry Mouth Inventory
Throat feels dry · Disagree a Little, Disagree, or Strongly Disagree
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-hour, Day 4Product 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
Outcome measures
| Measure |
Water/Negative Control
n=20 Participants
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.
Water control: negative control
|
Marketed Mouth Rinse
n=19 Participants
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.
Marketed Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.
|
Experimental Mouth Rinse
n=19 Participants
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.
Experimental Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.
|
|---|---|---|---|
|
Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4
|
1.79 units on a scale
Standard Error 0.197
|
2.97 units on a scale
Standard Error 0.204
|
3.33 units on a scale
Standard Error 0.203
|
Adverse Events
Water/Negative Control
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Marketed Mouth Rinse
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Experimental Mouth Rinse
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Water/Negative Control
n=20 participants at risk
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.
Water control: negative control
|
Marketed Mouth Rinse
n=19 participants at risk
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.
Marketed Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.
|
Experimental Mouth Rinse
n=19 participants at risk
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.
Experimental Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.
|
|---|---|---|---|
|
Gastrointestinal disorders
Stomatitis
|
15.0%
3/20 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
5.3%
1/19 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
5.3%
1/19 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
|
Injury, poisoning and procedural complications
mouth injury
|
5.0%
1/20 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
5.3%
1/19 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
0.00%
0/19 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
|
Infections and infestations
oral herpes
|
5.0%
1/20 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
0.00%
0/19 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
0.00%
0/19 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
|
Gastrointestinal disorders
cheilitis
|
0.00%
0/20 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
0.00%
0/19 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
5.3%
1/19 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
|
Gastrointestinal disorders
Gingival Pain
|
0.00%
0/20 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
5.3%
1/19 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
0.00%
0/19 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/20 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
5.3%
1/19 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
0.00%
0/19 • Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place