Trial Outcomes & Findings for Improvement of Dry Mouth Sufferers After Using an Experimental Dry Mouth Rinse Compared to a Water Control (NCT NCT04189081)
NCT ID: NCT04189081
Last Updated: 2021-05-28
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
137 participants
Primary outcome timeframe
4-hours
Results posted on
2021-05-28
Participant Flow
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
Participant milestones
| Measure |
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
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
45
|
46
|
|
Overall Study
COMPLETED
|
45
|
45
|
45
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Improvement of Dry Mouth Sufferers After Using an Experimental Dry Mouth Rinse Compared to a Water Control
Baseline characteristics by cohort
| Measure |
Water Control
n=46 Participants
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
|
Experimental Mouth Rinse
n=45 Participants
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.
|
Positive Control
n=46 Participants
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.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 11.83 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 14.97 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 12.04 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 12.95 • n=4 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4-hoursProduct 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
Outcome measures
| Measure |
Water Control
n=46 Participants
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
|
Experimental Mouth Rinse
n=45 Participants
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.
|
Positive Control
n=46 Participants
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.
|
|---|---|---|---|
|
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
|
3.26 score on a scale
Standard Error 0.160
|
3.43 score on a scale
Standard Error 0.158
|
PRIMARY outcome
Timeframe: 6-hoursProduct 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
Outcome measures
| Measure |
Water Control
n=46 Participants
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
|
Experimental Mouth Rinse
n=45 Participants
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.
|
Positive Control
n=46 Participants
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.
|
|---|---|---|---|
|
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
|
3.46 score on a scale
Standard Error 0.156
|
3.36 score on a scale
Standard Error 0.154
|
Adverse Events
Water Control
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
Positive Control
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 Control
n=46 participants at risk
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
|
Experimental Mouth Rinse
n=45 participants at risk
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.
|
Positive Control
n=46 participants at risk
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.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
mouth injury
|
6.5%
3/46 • Number of events 3 • Products were used over 8 days
investigator/examiner observed
|
4.4%
2/45 • Number of events 2 • Products were used over 8 days
investigator/examiner observed
|
2.2%
1/46 • Number of events 1 • Products were used over 8 days
investigator/examiner observed
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
0.00%
0/46 • Products were used over 8 days
investigator/examiner observed
|
0.00%
0/45 • Products were used over 8 days
investigator/examiner observed
|
2.2%
1/46 • Number of events 2 • Products were used over 8 days
investigator/examiner observed
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI agreed to not publish results without prior written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER