Trial Outcomes & Findings for Effect of Antibacterial Mouthwash on Muscle Function in Healthy Young Men and Women (NCT NCT04095442)
NCT ID: NCT04095442
Last Updated: 2024-03-18
Results Overview
Maximal knee extensor speed determined using isokinetic dynamometry
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
1 day
Results posted on
2024-03-18
Participant Flow
Participant milestones
| Measure |
Cepacol
Cepacol: Twice-daily use of Cepacol per the manufacturer's guidelines
|
Tom's Natural Mouthwash
Tom's Natural Mouthwash: Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cepacol
Cepacol: Twice-daily use of Cepacol per the manufacturer's guidelines
|
Tom's Natural Mouthwash
Tom's Natural Mouthwash: Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Screen failure
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cepacol
n=15 Participants
Cepacol: Twice-daily use of Cepacol per the manufacturer's guidelines
|
Tom's Natural Mouthwash
n=15 Participants
Tom's Natural Mouthwash: Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22 years
STANDARD_DEVIATION 4 • n=15 Participants
|
23 years
STANDARD_DEVIATION 3 • n=15 Participants
|
22 years
STANDARD_DEVIATION 3 • n=30 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
12 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
18 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
26 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 1 dayMaximal knee extensor speed determined using isokinetic dynamometry
Outcome measures
| Measure |
Cepacol
n=13 Participants
Cepacol: Twice-daily use of Cepacol per the manufacturer's guidelines
|
Tom's Natural Mouthwash
n=13 Participants
Tom's Natural Mouthwash: Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
|
|---|---|---|
|
Muscle Function
|
11.0 rad/s
Standard Deviation 2.2
|
13.1 rad/s
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: 7 dayMaximal knee extensor speed determined using isokinetic dynamometry
Outcome measures
| Measure |
Cepacol
n=13 Participants
Cepacol: Twice-daily use of Cepacol per the manufacturer's guidelines
|
Tom's Natural Mouthwash
n=13 Participants
Tom's Natural Mouthwash: Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
|
|---|---|---|
|
Muscle Function
|
13.3 rad/s
Standard Deviation 3.0
|
13.6 rad/s
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 1 daySalivary concentration of nitrate
Outcome measures
| Measure |
Cepacol
n=13 Participants
Cepacol: Twice-daily use of Cepacol per the manufacturer's guidelines
|
Tom's Natural Mouthwash
n=13 Participants
Tom's Natural Mouthwash: Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
|
|---|---|---|
|
Salivary Nitrate
|
407 umol/L
Standard Deviation 229
|
595 umol/L
Standard Deviation 359
|
SECONDARY outcome
Timeframe: 7 daySalivary concentration of nitrite
Outcome measures
| Measure |
Cepacol
n=13 Participants
Cepacol: Twice-daily use of Cepacol per the manufacturer's guidelines
|
Tom's Natural Mouthwash
n=13 Participants
Tom's Natural Mouthwash: Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
|
|---|---|---|
|
Salivary Nitrite
|
602 umol/L
Standard Deviation 490
|
533 umol/L
Standard Deviation 310
|
SECONDARY outcome
Timeframe: 1 dayBreath nitric oxide level
Outcome measures
| Measure |
Cepacol
n=8 Participants
Cepacol: Twice-daily use of Cepacol per the manufacturer's guidelines
|
Tom's Natural Mouthwash
n=7 Participants
Tom's Natural Mouthwash: Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
|
|---|---|---|
|
Breath Nitric Oxide
|
17 ppm
Standard Deviation 10
|
20 ppm
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 7 dayBreath nitric oxide level
Outcome measures
| Measure |
Cepacol
n=8 Participants
Cepacol: Twice-daily use of Cepacol per the manufacturer's guidelines
|
Tom's Natural Mouthwash
n=7 Participants
Tom's Natural Mouthwash: Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
|
|---|---|---|
|
Breath Nitric Oxide
|
17 ppm
Standard Deviation 7
|
20 ppm
Standard Deviation 10
|
Adverse Events
Cepacol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tom's Natural Mouthwash
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place