Trial Outcomes & Findings for Controlling Oral Malodor by ClōSYS Oral Rinse (NCT NCT03160573)
NCT ID: NCT03160573
Last Updated: 2020-12-22
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
Weekly for three weeks
Results posted on
2020-12-22
Participant Flow
United Health Resources Group (UHRG) was responsible for recruitment using advertising and volunteers from their website. All patients were recruited at a single UHRG site (7721 S. Painter Ave, Whittier, CA 90602)
No significant events prior to assignment to an arm.
Participant milestones
| Measure |
Test-Unflavored Rinse Then Placebo-Unflavored Rinse
CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution
ClōSYS® Unflavored Rinse: Subjects in Test group will receive ClōSYS® Unflavored Rinse then Placebo-Unflavored rinse
|
Test-Flavored Rinse Then Placebo-Flavored Rinse
CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution
ClōSYS® Flavored Rinse: Subjects in Test group will receive ClōSYS® Flavored Rinse then Placebo Flavored Rinse
|
Flavored Oral Rinse-Placebo Then Test-Flavored Rinse
CloSYS mint flavored rinse containing NO 0.1% stabilized chlorine dioxide
Flavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Flavored Rinse then CloSYS mint flavored rinse containing 0.1% stabilized chlorine dioxide
|
Unflavored Oral Rinse-Placebo Then Test-Unflavored Oral Rinse
CloSYS unflavored rinse containing NO 0.1% stabilized chlorine dioxide
Unflavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Unflavored Rinse then CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide
|
|---|---|---|---|---|
|
First Sequence (3 Weeks)
STARTED
|
23
|
26
|
25
|
25
|
|
First Sequence (3 Weeks)
COMPLETED
|
22
|
23
|
23
|
23
|
|
First Sequence (3 Weeks)
NOT COMPLETED
|
1
|
3
|
2
|
2
|
|
Washout (2 Weeks)
STARTED
|
22
|
23
|
23
|
23
|
|
Washout (2 Weeks)
COMPLETED
|
22
|
23
|
23
|
23
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Sequence (3 Weeks)
STARTED
|
22
|
23
|
23
|
23
|
|
Second Sequence (3 Weeks)
COMPLETED
|
22
|
23
|
23
|
23
|
|
Second Sequence (3 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test-Unflavored Rinse Then Placebo-Unflavored Rinse
CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution
ClōSYS® Unflavored Rinse: Subjects in Test group will receive ClōSYS® Unflavored Rinse then Placebo-Unflavored rinse
|
Test-Flavored Rinse Then Placebo-Flavored Rinse
CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution
ClōSYS® Flavored Rinse: Subjects in Test group will receive ClōSYS® Flavored Rinse then Placebo Flavored Rinse
|
Flavored Oral Rinse-Placebo Then Test-Flavored Rinse
CloSYS mint flavored rinse containing NO 0.1% stabilized chlorine dioxide
Flavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Flavored Rinse then CloSYS mint flavored rinse containing 0.1% stabilized chlorine dioxide
|
Unflavored Oral Rinse-Placebo Then Test-Unflavored Oral Rinse
CloSYS unflavored rinse containing NO 0.1% stabilized chlorine dioxide
Unflavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Unflavored Rinse then CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide
|
|---|---|---|---|---|
|
First Sequence (3 Weeks)
Withdrawal by Subject
|
1
|
3
|
2
|
2
|
Baseline Characteristics
Controlling Oral Malodor by ClōSYS Oral Rinse
Baseline characteristics by cohort
| Measure |
Test-Unflavored Rinse Then Placebo Unflavored Rinse
n=23 Participants
CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution
ClōSYS® Unflavored Rinse: Subjects in Test group will receive ClōSYS® Unflavored Rinse then CloSYS unflavored rinse containing NO 0.1% stabilized chlorine dioxide.
|
Test-Flavored Rinse Then Placebo Flavored Rinse
n=26 Participants
CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution
ClōSYS® Flavored Rinse: Subjects in Test group will receive ClōSYS® Flavored Rinse then CloSYS mint flavored rinse containing NO 0.1% stabilized chlorine dioxide.
|
Flavored Oral Rinse-Placebo Then Test-Flavored Rinse
n=25 Participants
CloSYS mint flavored rinse containing NO 0.1% stabilized chlorine dioxide
Flavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Flavored Rinse then CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution.
|
Unflavored Oral Rinse-Placebo Then Unflavored Oral Rinse
n=25 Participants
CloSYS unflavored rinse containing NO 0.1% stabilized chlorine dioxide
Unflavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Unflavored Rinse then CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
31 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
26 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
99 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Weekly for three weeksA 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.
Outcome measures
| Measure |
Test-Unflavored Rinse Then Placebo Unflavored Rinse
n=23 Participants
CloSYS unflavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution
ClōSYS® Unflavored Rinse: Subjects in Test group will receive ClōSYS® Unflavored Rinse then Placebo Unflavored rinse
|
Test-Flavored Rinse Then Placebo Flavored Rinse
n=23 Participants
CloSYS mint-flavored rinse containing 0.1% stabilized chlorine dioxide (sodium chlorite) in an aqueous solution
ClōSYS® Flavored Rinse: Subjects in Test group will receive ClōSYS® Flavored Rinse then Placebo Flavored Rinse
|
Flavored Oral Rinse-Placebo Then Test Flavored Oral Rinse
n=23 Participants
CloSYS mint flavored rinse containing NO 0.1% stabilized chlorine dioxide
Flavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Flavored Rinse then Test Flavored Oral Rinse
|
Unflavored Oral Rinse-Placebo Then Test Unflavored Oral Rinse
n=24 Participants
CloSYS unflavored rinse containing NO 0.1% stabilized chlorine dioxide
Unflavored Oral Rinse - Placebo: Subjects in Placebo group will receive Placebo Unflavored Rinse
|
|---|---|---|---|---|
|
Reduction in Malodor as Measured by Organoleptic Score
Visit 2-2
|
2.91 score on a scale
Standard Deviation 0.35
|
1.48 score on a scale
Standard Deviation 0.60
|
2.83 score on a scale
Standard Deviation 0.50
|
1.47 score on a scale
Standard Deviation 0.63
|
|
Reduction in Malodor as Measured by Organoleptic Score
Baseline 1
|
3.58 score on a scale
Standard Deviation 0.67
|
3.60 score on a scale
Standard Deviation 0.63
|
3.63 score on a scale
Standard Deviation 0.62
|
3.65 score on a scale
Standard Deviation 0.66
|
|
Reduction in Malodor as Measured by Organoleptic Score
Visit 1
|
2.93 score on a scale
Standard Deviation 0.40
|
2.19 score on a scale
Standard Deviation 0.51
|
3.03 score on a scale
Standard Deviation 0.64
|
2.29 score on a scale
Standard Deviation 0.65
|
|
Reduction in Malodor as Measured by Organoleptic Score
Visit 2
|
2.39 score on a scale
Standard Deviation 0.61
|
1.45 score on a scale
Standard Deviation 0.51
|
2.73 score on a scale
Standard Deviation 0.60
|
1.81 score on a scale
Standard Deviation .58
|
|
Reduction in Malodor as Measured by Organoleptic Score
Visit 3
|
2.30 score on a scale
Standard Deviation .67
|
1.15 score on a scale
Standard Deviation 0.37
|
2.65 score on a scale
Standard Deviation 0.56
|
1.40 score on a scale
Standard Deviation .61
|
|
Reduction in Malodor as Measured by Organoleptic Score
Baseline-2
|
3.28 score on a scale
Standard Deviation 0.52
|
3.25 score on a scale
Standard Deviation 0.52
|
3.05 score on a scale
Standard Deviation 0.38
|
3.21 score on a scale
Standard Deviation 0.52
|
|
Reduction in Malodor as Measured by Organoleptic Score
Visit 1-2
|
3.00 score on a scale
Standard Deviation 0.35
|
2.08 score on a scale
Standard Deviation 0.56
|
2.89 score on a scale
Standard Deviation 0.47
|
2.08 score on a scale
Standard Deviation 0.74
|
|
Reduction in Malodor as Measured by Organoleptic Score
Visit 3-2
|
2.90 score on a scale
Standard Deviation 0.35
|
1.25 score on a scale
Standard Deviation 0.47
|
2.83 score on a scale
Standard Deviation 0.50
|
1.34 score on a scale
Standard Deviation 0.60
|
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
Flavored Oral Rinse-Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unflavored Oral Rinse-Placebo
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
Sushma Nachnani, MS, PhD
University Health Resources Group
Phone: (310) 645-8576
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place