Trial Outcomes & Findings for A Four-Week Study to Measure the Effectiveness of an Experimental Mouthwash Used After Teeth Cleaning (NCT NCT01462110)
NCT ID: NCT01462110
Last Updated: 2020-04-07
Results Overview
Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index (MGI) where 0=Normal and 4=Severe Inflammation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
4 weeks
Results posted on
2020-04-07
Participant Flow
Participant milestones
| Measure |
5% Hydroalcohol Mouthrinse
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
|
0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
|
Overall Study
COMPLETED
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
5% Hydroalcohol Mouthrinse
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
|
0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Four-Week Study to Measure the Effectiveness of an Experimental Mouthwash Used After Teeth Cleaning
Baseline characteristics by cohort
| Measure |
5% Hydroalcohol Mouthrinse
n=44 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
|
0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 10.35 • n=5 Participants
|
34.0 years
STANDARD_DEVIATION 8.05 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 9.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Smoker
Yes
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Smoker
No
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Smokeless Tabacco Use
Yes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Smokeless Tabacco Use
No
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Mean Plaque Index - Whole Mouth
|
2.996 Units on a scale
STANDARD_DEVIATION 0.2222 • n=5 Participants
|
2.926 Units on a scale
STANDARD_DEVIATION 0.2866 • n=7 Participants
|
2.961 Units on a scale
STANDARD_DEVIATION 0.257 • n=5 Participants
|
|
Modified Gingival Index - Whole Mouth
|
2.196 Units on a scale
STANDARD_DEVIATION 0.0989 • n=5 Participants
|
2.172 Units on a scale
STANDARD_DEVIATION 0.1132 • n=7 Participants
|
2.184 Units on a scale
STANDARD_DEVIATION 0.106 • n=5 Participants
|
|
Gingival Bleeding Index - Whole Mouth
|
0.137 Units on a scale
STANDARD_DEVIATION 0.0614 • n=5 Participants
|
0.129 Units on a scale
STANDARD_DEVIATION 0.0634 • n=7 Participants
|
0.133 Units on a scale
STANDARD_DEVIATION 0.062 • n=5 Participants
|
|
Microbiological Assessments - Absolute Counts
Actinomyces species
|
3.206 10^5 bacterial cells
STANDARD_DEVIATION 1.7377 • n=5 Participants
|
3.319 10^5 bacterial cells
STANDARD_DEVIATION 1.8306 • n=7 Participants
|
3.262 10^5 bacterial cells
STANDARD_DEVIATION 1.7747 • n=5 Participants
|
|
Microbiological Assessments - Absolute Counts
Purple complex
|
2.207 10^5 bacterial cells
STANDARD_DEVIATION 1.7989 • n=5 Participants
|
2.181 10^5 bacterial cells
STANDARD_DEVIATION 1.888 • n=7 Participants
|
2.194 10^5 bacterial cells
STANDARD_DEVIATION 1.5193 • n=5 Participants
|
|
Microbiological Assessments - Absolute Counts
Yellow complex
|
2.400 10^5 bacterial cells
STANDARD_DEVIATION 2.2929 • n=5 Participants
|
2.535 10^5 bacterial cells
STANDARD_DEVIATION 1.5893 • n=7 Participants
|
2.467 10^5 bacterial cells
STANDARD_DEVIATION 1.9664 • n=5 Participants
|
|
Microbiological Assessments - Absolute Counts
Green complex
|
7.988 10^5 bacterial cells
STANDARD_DEVIATION 8.8495 • n=5 Participants
|
6.841 10^5 bacterial cells
STANDARD_DEVIATION 6.5277 • n=7 Participants
|
7.421 10^5 bacterial cells
STANDARD_DEVIATION 7.7653 • n=5 Participants
|
|
Microbiological Assessments - Absolute Counts
Orange complex
|
5.252 10^5 bacterial cells
STANDARD_DEVIATION 3.6072 • n=5 Participants
|
4.923 10^5 bacterial cells
STANDARD_DEVIATION 3.6457 • n=7 Participants
|
5.089 10^5 bacterial cells
STANDARD_DEVIATION 3.6089 • n=5 Participants
|
|
Microbiological Assessments - Absolute Counts
Red complex
|
1.638 10^5 bacterial cells
STANDARD_DEVIATION 0.8182 • n=5 Participants
|
1.509 10^5 bacterial cells
STANDARD_DEVIATION 0.8192 • n=7 Participants
|
1.574 10^5 bacterial cells
STANDARD_DEVIATION 0.8165 • n=5 Participants
|
|
Microbiological Assessments - Absolute Counts
Other species
|
7.646 10^5 bacterial cells
STANDARD_DEVIATION 6.1549 • n=5 Participants
|
7.322 10^5 bacterial cells
STANDARD_DEVIATION 6.2088 • n=7 Participants
|
7.486 10^5 bacterial cells
STANDARD_DEVIATION 6.1477 • n=5 Participants
|
|
Microbiological Assessments - LOG Counts
Actinomyces species
|
5.410 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3647 • n=5 Participants
|
5.440 LOG counts of bacterial cells
STANDARD_DEVIATION 0.2935 • n=7 Participants
|
5.425 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3298 • n=5 Participants
|
|
Microbiological Assessments - LOG Counts
Purple complex
|
5.213 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3985 • n=5 Participants
|
5.255 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3107 • n=7 Participants
|
5.234 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3563 • n=5 Participants
|
|
Microbiological Assessments - LOG Counts
Yellow complex
|
5.249 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3433 • n=5 Participants
|
5.302 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3284 • n=7 Participants
|
5.275 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3351 • n=5 Participants
|
|
Microbiological Assessments - LOG Counts
Green complex
|
5.717 LOG counts of bacterial cells
STANDARD_DEVIATION 0.4232 • n=5 Participants
|
5.660 LOG counts of bacterial cells
STANDARD_DEVIATION 0.4038 • n=7 Participants
|
5.689 LOG counts of bacterial cells
STANDARD_DEVIATION 0.4123 • n=5 Participants
|
|
Microbiological Assessments - LOG Counts
Orange complex
|
5.603 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3506 • n=5 Participants
|
5.583 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3226 • n=7 Participants
|
5.593 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3352 • n=5 Participants
|
|
Microbiological Assessments - LOG Counts
Red complex
|
5.149 LOG counts of bacterial cells
STANDARD_DEVIATION 0.2624 • n=5 Participants
|
5.110 LOG counts of bacterial cells
STANDARD_DEVIATION 0.2584 • n=7 Participants
|
5.130 LOG counts of bacterial cells
STANDARD_DEVIATION 0.2596 • n=5 Participants
|
|
Microbiological Assessments - LOG Counts
Other species
|
5.756 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3524 • n=5 Participants
|
5.722 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3660 • n=7 Participants
|
5.739 LOG counts of bacterial cells
STANDARD_DEVIATION 0.3575 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.
Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index (MGI) where 0=Normal and 4=Severe Inflammation.
Outcome measures
| Measure |
5% Hydroalcohol Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
|
0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
|
|---|---|---|
|
Whole-mouth Mean Modified Gingival Index (MGI)
|
2.199 Units on a scale
Standard Deviation 0.0934
|
1.948 Units on a scale
Standard Deviation 0.1548
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.
Plaque was assessed on a scale of 0-5 using the Turesky modification of the Quigley-Hein Plaque Index, where 0=No plaque and 5=Plaque covering 2/3 or more of surface.
Outcome measures
| Measure |
5% Hydroalcohol Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
|
0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
|
|---|---|---|
|
Whole-mouth Mean Plaque Index (PI)
|
2.922 Units on a scale
Standard Deviation 0.1953
|
1.634 Units on a scale
Standard Deviation 0.5724
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Intent to treat population was used for analysis.
Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index, where 0=Normal and 4=Severe Inflammation.
Outcome measures
| Measure |
5% Hydroalcohol Mouthrinse
n=44 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
|
0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
|
|---|---|---|
|
Whole-mouth Mean Modified Gingival Index (MGI)
|
2.189 Units on a scale
Standard Deviation 0.1014
|
2.067 Units on a scale
Standard Deviation 0.1185
|
SECONDARY outcome
Timeframe: 2 WeeksPopulation: The intent-to-treat population was used for analysis.
Plaque was assessed on a scale of 0-5 using the Turesky modification of the Quigley-Hein Plaque Index, where 0=No plaque and 5=Plaque covering 2/3 or more of surface.
Outcome measures
| Measure |
5% Hydroalcohol Mouthrinse
n=44 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
|
0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
|
|---|---|---|
|
Whole-mouth Mean Plaque Index (PI)
|
2.880 Units on a scale
Standard Deviation 0.2678
|
1.987 Units on a scale
Standard Deviation 0.6539
|
SECONDARY outcome
Timeframe: 2 WeeksPopulation: Intent to treat population was analyzed.
Bleeding after periodontal probe was assessed by scores on a scale of 0-2 using the Gingival Bleeding Index (BI), where 0=Absence of Bleeding after 30 Seconds and 2=Immediate Bleeding.
Outcome measures
| Measure |
5% Hydroalcohol Mouthrinse
n=44 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
|
0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
|
|---|---|---|
|
Whole-mouth Mean Bleeding Index (BI)
|
0.123 Units on a scale
Standard Deviation 0.0569
|
0.074 Units on a scale
Standard Deviation 0.0528
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.
Bleeding after periodontal probe was assessed by scores on a scale of 0-2 using the Gingival Bleeding Index (BI), where 0=Absence of Bleeding after 30 Seconds and 2=Immediate Bleeding.
Outcome measures
| Measure |
5% Hydroalcohol Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
|
0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
|
|---|---|---|
|
Whole-mouth Mean Bleeding Index (BI)
|
0.120 Units on a scale
Standard Deviation 0.0524
|
0.057 Units on a scale
Standard Deviation 0.0520
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.
An assay (a checkerboard DNA-DNA hybridization) was conducted to estimate the number of bacterial cells in collected plaque samples. First, the bacterial cells were lysed (split open) in solution. DNA from the bacteria was then detected using fluorescent probes for different bacterial species. The sensitivity of the assay was 10\^4 cells and failure to detect a signal was recorded as zero. Signals were converted to absolute counts by comparison with the fluorescent signal of standards of known concentrations. The following hybridized categories of bacteria were analyzed: * Actinomyces species * Purple complex * Yellow complex * Green complex * Orange complex * Red complex * Other species
Outcome measures
| Measure |
5% Hydroalcohol Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
|
0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
|
|---|---|---|
|
Microbiological Assessments - Absolute Counts
Actinomyces species
|
1.868 10^5 bacterial cells
Standard Deviation 1.5514
|
1.847 10^5 bacterial cells
Standard Deviation 1.2609
|
|
Microbiological Assessments - Absolute Counts
Purple complex
|
0.910 10^5 bacterial cells
Standard Deviation 0.9723
|
0.663 10^5 bacterial cells
Standard Deviation 0.6454
|
|
Microbiological Assessments - Absolute Counts
Yellow complex
|
1.050 10^5 bacterial cells
Standard Deviation 0.8595
|
1.018 10^5 bacterial cells
Standard Deviation 0.7001
|
|
Microbiological Assessments - Absolute Counts
Green complex
|
4.530 10^5 bacterial cells
Standard Deviation 3.8225
|
3.174 10^5 bacterial cells
Standard Deviation 2.4853
|
|
Microbiological Assessments - Absolute Counts
Orange complex
|
3.562 10^5 bacterial cells
Standard Deviation 3.1562
|
3.602 10^5 bacterial cells
Standard Deviation 2.4298
|
|
Microbiological Assessments - Absolute Counts
Red complex
|
1.346 10^5 bacterial cells
Standard Deviation 1.0472
|
1.111 10^5 bacterial cells
Standard Deviation 0.6017
|
|
Microbiological Assessments - Absolute Counts
Other Species
|
4.471 10^5 bacterial cells
Standard Deviation 3.9108
|
3.385 10^5 bacterial cells
Standard Deviation 2.3474
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.
An assay (a checkerboard DNA-DNA hybridization) was conducted to estimate the number of bacterial cells in collected plaque samples. First, the bacterial cells were lysed (split open) in solution. DNA from the bacteria was then detected using fluorescent probes for different bacterial species. The sensitivity of the assay was 10\^4 cells and failure to detect a signal was recorded as zero. Signals were converted to log counts by comparison with the fluorescent signal of standards of known concentrations. The following hybridized categories of bacteria were analyzed: * Actinomyces species * Purple complex * Yellow complex * Green complex * Orange complex * Red complex * Other species
Outcome measures
| Measure |
5% Hydroalcohol Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
|
0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
n=43 Participants
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
|
|---|---|---|
|
Microbiological Assessments - LOG Counts
Actinomyces species
|
5.089 LOG counts of bacterial cells
Standard Deviation 0.4432
|
5.154 LOG counts of bacterial cells
Standard Deviation 0.3491
|
|
Microbiological Assessments - LOG Counts
Purple complex
|
4.721 LOG counts of bacterial cells
Standard Deviation 0.5443
|
4.617 LOG counts of bacterial cells
Standard Deviation 0.4546
|
|
Microbiological Assessments - LOG Counts
Yellow complex
|
4.882 LOG counts of bacterial cells
Standard Deviation 0.3674
|
4.915 LOG counts of bacterial cells
Standard Deviation 0.2855
|
|
Microbiological Assessments - LOG Counts
Green complex
|
5.477 LOG counts of bacterial cells
Standard Deviation 0.4354
|
5.400 LOG counts of bacterial cells
Standard Deviation 0.2935
|
|
Microbiological Assessments - LOG Counts
Orange complex
|
5.401 LOG counts of bacterial cells
Standard Deviation 0.3761
|
5.461 LOG counts of bacterial cells
Standard Deviation 0.3008
|
|
Microbiological Assessments - LOG Counts
Red complex
|
5.012 LOG counts of bacterial cells
Standard Deviation 0.3354
|
4.977 LOG counts of bacterial cells
Standard Deviation 0.2637
|
|
Microbiological Assessments - LOG Counts
Other Species
|
5.509 LOG counts of bacterial cells
Standard Deviation 0.3637
|
5.433 LOG counts of bacterial cells
Standard Deviation 0.3005
|
Adverse Events
5% Hydroalcohol Mouthrinse
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5% Hydroalcohol Mouthrinse
n=44 participants at risk
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 5% hydroalcohol mouthrinse (W002194-0221P) for 30 seconds - repeat twice daily for four weeks.
|
0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
n=43 participants at risk
Brush teeth as usual, followed immediately by rinsing with 20 mL of assigned 0.15% ethyl lauroyl arginate HCl-containing mouthrinse (19415-154-1) for 30 seconds - repeat twice daily for four weeks.
|
|---|---|---|
|
Reproductive system and breast disorders
Testicular Swelling
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) were collected from time of informed consent through subject's last study procedure (Week 4, unless terminated early). Serious adverse events (SAE) reported to the site were also reportable within 30 calendar days of last procedure/visit and longer if considered study-related; there was no specific cut-off date for this reporting,
|
0.00%
0/43 • Adverse events (AEs) were collected from time of informed consent through subject's last study procedure (Week 4, unless terminated early). Serious adverse events (SAE) reported to the site were also reportable within 30 calendar days of last procedure/visit and longer if considered study-related; there was no specific cut-off date for this reporting,
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI must provide Sponsor 60 days to review any publication (unless expedited review requested); if includes Sponsor's confidential info, written Sponsor approval is required. Sponsor may require another 60 days' delay to file patent app. If multicenter, PI agrees 1st publication is joint publication. If join publication not submitted within 24 months of study end or Sponsor confirms there will be no joint publication, PI may publish the results individually following previous guidelines.
- Publication restrictions are in place
Restriction type: OTHER