Trial Outcomes & Findings for Controlling Oral Malodor by ClōSYS® Oral Rinse (NCT NCT03160560)
NCT ID: NCT03160560
Last Updated: 2021-01-07
Results Overview
A 6-level organoleptic score from 0 - 5 will be used. Score of 0 indicating malodor cannot be detected and score of 5 indicating very strong malodor. Breath scores were compared to baseline with malodor intensity reduction recorded as negative.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
At baseline and weekly for 3 weeks for each condition and cross-over
Results posted on
2021-01-07
Participant Flow
Study panelists were recruited by placing IRB-approved advertisements in the the Loma Linda University newsletter and local communities. Potential subjects were interviewed by telephone and screened for their eligibility to participate in the study.
Participant milestones
| Measure |
Test-Unflavored Rinse, Then Placebo
Participants received ClōSYS® Unflavored Rinse for use for 3 weeks. After a 2-week washout period, the subjects received Placebo rinse for use for 3 weeks.
|
Test-Flavored Rinse, Then Placebo
Participants received ClōSYS® Flavored Rinse for use for 3 weeks. After a 2-week washout period, the subjects received Placebo rinse for use for 3 weeks.
|
Placebo, Then Flavored Rinse
Participants received Placebo for use for 3 weeks. After a 2-week washout period, the subjects received ClōSYS® Flavored Rinse rinse for use for 3 weeks.
|
Placebo, Then Unflavored Rinse
Participants received Placebo for use for 3 weeks. After a 2-week washout period, the subjects received ClōSYS® Unflavored Rinse rinse for use for 3 weeks.
|
|---|---|---|---|---|
|
First Intervention (3 Weeks)
STARTED
|
25
|
25
|
25
|
25
|
|
First Intervention (3 Weeks)
COMPLETED
|
23
|
24
|
24
|
25
|
|
First Intervention (3 Weeks)
NOT COMPLETED
|
2
|
1
|
1
|
0
|
|
Washout (2 Weeks)
STARTED
|
23
|
24
|
24
|
25
|
|
Washout (2 Weeks)
COMPLETED
|
23
|
24
|
24
|
25
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention (3 Weeks)
STARTED
|
23
|
24
|
24
|
25
|
|
Second Intervention (3 Weeks)
COMPLETED
|
22
|
24
|
24
|
25
|
|
Second Intervention (3 Weeks)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test-Unflavored Rinse, Then Placebo
Participants received ClōSYS® Unflavored Rinse for use for 3 weeks. After a 2-week washout period, the subjects received Placebo rinse for use for 3 weeks.
|
Test-Flavored Rinse, Then Placebo
Participants received ClōSYS® Flavored Rinse for use for 3 weeks. After a 2-week washout period, the subjects received Placebo rinse for use for 3 weeks.
|
Placebo, Then Flavored Rinse
Participants received Placebo for use for 3 weeks. After a 2-week washout period, the subjects received ClōSYS® Flavored Rinse rinse for use for 3 weeks.
|
Placebo, Then Unflavored Rinse
Participants received Placebo for use for 3 weeks. After a 2-week washout period, the subjects received ClōSYS® Unflavored Rinse rinse for use for 3 weeks.
|
|---|---|---|---|---|
|
First Intervention (3 Weeks)
Withdrawal by Subject
|
2
|
1
|
1
|
0
|
|
Second Intervention (3 Weeks)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Participant-level, continuous data were collected for participants who did not discontinue the study.
Baseline characteristics by cohort
| Measure |
Test-Unflavored Rinse, Then Placebo
n=25 Participants
Participants received ClōSYS® Unflavored Rinse, Then Placebo Unflavored Rinse
|
Test-Flavored Rinse, Then Placebo
n=25 Participants
Subjects received ClōSYS® Flavored Rinse, Then Placebo Flavored Rinse.
|
Placebo, Then Flavored Rinse
n=25 Participants
Subjects in Placebo group received Placebo Rinse, then ClōSYS® Flavored Rinse
|
Placebo, Then Unflavored Rinse
n=25 Participants
Subjects in Placebo group received Placebo Rinse, then ClōSYS® Unflavored Rinse.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
100 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=100 Participants
|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 13.5 • n=23 Participants • Participant-level, continuous data were collected for participants who did not discontinue the study.
|
40.6 years
STANDARD_DEVIATION 13.3 • n=24 Participants • Participant-level, continuous data were collected for participants who did not discontinue the study.
|
38.2 years
STANDARD_DEVIATION 13.3 • n=24 Participants • Participant-level, continuous data were collected for participants who did not discontinue the study.
|
45.7 years
STANDARD_DEVIATION 13.9 • n=25 Participants • Participant-level, continuous data were collected for participants who did not discontinue the study.
|
42.5 years
STANDARD_DEVIATION 13.5 • n=96 Participants • Participant-level, continuous data were collected for participants who did not discontinue the study.
|
|
Sex: Female, Male
Female
|
10 Participants
n=23 Participants • Sex data were only collected from participants that did not elect to discontinue the study.
|
18 Participants
n=24 Participants • Sex data were only collected from participants that did not elect to discontinue the study.
|
16 Participants
n=24 Participants • Sex data were only collected from participants that did not elect to discontinue the study.
|
8 Participants
n=25 Participants • Sex data were only collected from participants that did not elect to discontinue the study.
|
52 Participants
n=96 Participants • Sex data were only collected from participants that did not elect to discontinue the study.
|
|
Sex: Female, Male
Male
|
13 Participants
n=23 Participants • Sex data were only collected from participants that did not elect to discontinue the study.
|
6 Participants
n=24 Participants • Sex data were only collected from participants that did not elect to discontinue the study.
|
8 Participants
n=24 Participants • Sex data were only collected from participants that did not elect to discontinue the study.
|
17 Participants
n=25 Participants • Sex data were only collected from participants that did not elect to discontinue the study.
|
44 Participants
n=96 Participants • Sex data were only collected from participants that did not elect to discontinue the study.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
100 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: At baseline and weekly for 3 weeks for each condition and cross-overPopulation: All participants
A 6-level organoleptic score from 0 - 5 will be used. Score of 0 indicating malodor cannot be detected and score of 5 indicating very strong malodor. Breath scores were compared to baseline with malodor intensity reduction recorded as negative.
Outcome measures
| Measure |
Unflavored Rinse, Then Placebo
n=23 Participants
CloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution.
ClōSYS® Unflavored Rinse: Subjects in Test group will receive ClōSYS® Unflavored Rinse, then Placebo.
|
Flavored Rinse, Then Placebo
n=24 Participants
CloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution with mint flavoring.
ClōSYS® Flavored Rinse: Subjects in Test group will receive ClōSYS® Flavored Rinse, then Placebo
|
Placebo Flavored, Then Flavored Rinse
n=24 Participants
CloSYS Oral Rinse product (no chlorine dioxide)
Placebo: Subjects in Placebo group will receive Placebo Rinse, then Flavored CloSYS Oral Rinse.
|
Placebo Unflavored, Then Unflavored Rinse
n=25 Participants
CloSYS Oral Rinse product containing 0.1% stabilized chlorine dioxide (sodium chlorite) in aqueous solution.
ClōSYS® Unflavored Rinse: Subjects in Test group will receive Placebo, then ClōSYS® Unflavored Rinse.
|
|---|---|---|---|---|
|
Change in Malodor as Measured by Organoleptic Score
Baseline
|
3.09 score on a scale
Standard Deviation .34
|
3.08 score on a scale
Standard Deviation .38
|
3.03 score on a scale
Standard Deviation .19
|
3.23 score on a scale
Standard Deviation .41
|
|
Change in Malodor as Measured by Organoleptic Score
Week 1
|
2.90 score on a scale
Standard Deviation .52
|
2.92 score on a scale
Standard Deviation .31
|
3.11 score on a scale
Standard Deviation .46
|
3.19 score on a scale
Standard Deviation .50
|
|
Change in Malodor as Measured by Organoleptic Score
Week 2
|
2.64 score on a scale
Standard Deviation .48
|
2.78 score on a scale
Standard Deviation .40
|
3.07 score on a scale
Standard Deviation .53
|
3.12 score on a scale
Standard Deviation .43
|
|
Change in Malodor as Measured by Organoleptic Score
Week 3
|
2.58 score on a scale
Standard Deviation .43
|
2.68 score on a scale
Standard Deviation .51
|
3.07 score on a scale
Standard Deviation .44
|
3.19 score on a scale
Standard Deviation .43
|
|
Change in Malodor as Measured by Organoleptic Score
Baseline 2-Crossover
|
3.44 score on a scale
Standard Deviation .50
|
3.20 score on a scale
Standard Deviation .44
|
3.15 score on a scale
Standard Deviation .42
|
3.14 score on a scale
Standard Deviation .46
|
|
Change in Malodor as Measured by Organoleptic Score
Week 6
|
3.18 score on a scale
Standard Deviation .61
|
3.04 score on a scale
Standard Deviation .49
|
3.17 score on a scale
Standard Deviation .46
|
3.0 score on a scale
Standard Deviation .41
|
|
Change in Malodor as Measured by Organoleptic Score
Week 7
|
3.01 score on a scale
Standard Deviation .59
|
2.94 score on a scale
Standard Deviation .48
|
3.13 score on a scale
Standard Deviation .40
|
3.10 score on a scale
Standard Deviation .5
|
|
Change in Malodor as Measured by Organoleptic Score
Week 8
|
2.96 score on a scale
Standard Deviation .49
|
2.83 score on a scale
Standard Deviation .44
|
3.10 score on a scale
Standard Deviation .40
|
3.09 score on a scale
Standard Deviation .43
|
Adverse Events
Test-Unflavored Rinse
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test-Flavored Rinse
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Flavored Rinse
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Unflavored Rinse
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Yiming Li, DDS, MSD, PhD, Professor and Associate Dean for Research
Center for Dental Research, Loma Linda University
Phone: 909-558-8069
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place