A Four-Week Study to Measure the Effectiveness of an Experimental Mouthwash Used After Teeth Cleaning

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01462110
• Collaborator: (none)
• Enrollment: 87
• Location: 1
• Arms: 2
• Actual Duration (Months): 1
• Patients Per Site Per Month: 85.4

Study Details

Study Description

Brief Summary

This study will test the idea that using an experimental mouth rinse after each time you brush your teeth will result in a healthier mouth than using the regular mouth rinse. Participants will be expected to avoid oral hygiene (like brushing teeth or using mouthwash) for at least 12 hours before each visit and will not be allowed to eat, drink or smoke for at least 4 hours before each visit.

At the first visit, the study will be explained to you in detail and you will be allowed to ask any questions you may have before signing a consent form. You will complete a medical/dental history and the dentist will examine your mouth, during which he will poke your gums and scrape some plaque off your teeth for testing. If you do not meet the requirements to continue in the trial, you will be told that you do not need to return for more testing.

If you meet requirements to continue, you will have an equal chance of being assigned to use either of the two mouth rinses being studied. You will be given a diary, toothbrush, toothpaste, and your assigned mouth rinse, with instructions on how they must be used.

You will be instructed not to use any unassigned oral care products and to follow your usual eating habits. You will be given appointments to return two times within the next four weeks. At those visits, the staff will check to make sure you're following the instructions and ask how you're feeling, and the dentist will do the same thing he did during the first visit.

Condition or Disease	Intervention/Treatment	Phase
Dental Plaque	Device: 19416-154-1; Device: W002194-0221P	N/A

Detailed Description

The primary objective of this randomized, double-blind, single-center, controlled, parallel-designed clinical study is to determine the efficacy of an experimental mouth rinse on whole-mouth mean plaque and gingivitis scores as an adjunct to brushing after four weeks of use.

The secondary objectives will be to determine the efficacy of the an experimental mouth rinse as an adjunct to brushing on whole-mouth mean plaque and gingivitis measured at 2 weeks as well as a bleeding assessment according to the Bleeding Index at 2 and 4 weeks. A microbiological assessment will be performed to identify and quantify specific oral microbes to assess any change in population.

Study Design

• Study Type: Interventional
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Determination of Anti-Plaque and Anti-Gingivitis Efficacy of One Experimental Mouthrinse Following a Baseline Oral Prophylaxis: A Four Week Study
• Actual Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Dec 2, 2011
• Actual Study Completion Date: Dec 2, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 19416-154-1; 0.15% ethyl lauroyl arginate HCl-containing mouthrinse; Other Names: Not Marketed
Sham Comparator: 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.	Device: W002194-0221P; 5% hydroalcohol mouthrinse; Other Names: Not Marketed

Outcome Measures

Primary Outcome Measures

1. Whole-mouth Mean Modified Gingival Index (MGI) [4 weeks]

   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.

2. Whole-mouth Mean Plaque Index (PI) [4 weeks]

   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.

Secondary Outcome Measures

1. Whole-mouth Mean Modified Gingival Index (MGI) [2 weeks]

   Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index, where 0=Normal and 4=Severe Inflammation.

2. Whole-mouth Mean Plaque Index (PI) [2 Weeks]

   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.

3. Whole-mouth Mean Bleeding Index (BI) [2 Weeks]

   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.

4. Whole-mouth Mean Bleeding Index (BI) [4 Weeks]

   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.

5. Microbiological Assessments - Absolute Counts [4 weeks]

   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

6. Microbiological Assessments - LOG Counts [4 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males and females at least 18 years of age and in good general health.

• Must display adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).

• Volunteers must read, sign, and receive a copy of the Informed Consent Form after the nature of the study has been fully explained.

• Must be willing to use the products according to instructions and be available for appointments.

• Baseline dental measurements meet protocol-specified criteria.

• Willingness to refrain from using all oral hygiene procedures within 12-18 hours prior to each visit.

• Refrain from eating, drinking or smoking for four hours prior to each visit.

Exclusion Criteria:

• Lip, tongue, or other form of oral piercing.

• Fixed or removable orthodontic appliance (such as bridges, braces or dentures).

• Pregnancy or breast-feeding at any time during the trial.

• Any medical, dental or psychiatric condition, abnormality or history, or use of any product or drug, that (per protocol or in the opinion of the investigator) may increase the risk to the subject associated with trial participation or investigational product administration, or interfere with the interpretation of trial results.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BioSci Research Inc.	Las Vegas	Nevada	United States	89121

Sponsors and Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide

Investigators

• Study Director: Marcelo Araujo, DDS, MS, PhD, Johnson & Johnson Consumer and Personal Products Worldwide

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
• ClinicalTrials.gov Identifier: NCT01462110
• Other Study ID Numbers: LAEBBA0001
• First Posted: Oct 31, 2011
• Last Update Posted: Apr 7, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide: Gingivitis; Microorganisms
• Additional relevant MeSH terms: Dental Plaque

Study Results

Participant Flow

Arm/Group Title	5% Hydroalcohol Mouthrinse	0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	44	43
COMPLETED	43	43
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	5% Hydroalcohol Mouthrinse	0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	44	43	87
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.6 (10.35)	34.0 (8.05)	34.8 (9.26)
Sex: Female, Male (Count of Participants)
Female	23 52.3%	30 69.8%	53 60.9%
Male	21 47.7%	13 30.2%	34 39.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 11.4%	6 14%	11 12.6%
Not Hispanic or Latino	39 88.6%	37 86%	76 87.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 2.3%	1 1.1%
Asian	3 6.8%	3 7%	6 6.9%
Native Hawaiian or Other Pacific Islander	4 9.1%	4 9.3%	8 9.2%
Black or African American	14 31.8%	9 20.9%	23 26.4%
White	23 52.3%	26 60.5%	49 56.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Smoker (Count of Participants)
Yes	4 9.1%	6 14%	10 11.5%
No	40 90.9%	37 86%	77 88.5%
Smokeless Tabacco Use (Count of Participants)
Yes	1 2.3%	0 0%	1 1.1%
No	43 97.7%	43 100%	86 98.9%
Mean Plaque Index - Whole Mouth (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	2.996 (0.2222)	2.926 (0.2866)	2.961 (0.257)
Modified Gingival Index - Whole Mouth (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	2.196 (0.0989)	2.172 (0.1132)	2.184 (0.106)
Gingival Bleeding Index - Whole Mouth (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	0.137 (0.0614)	0.129 (0.0634)	0.133 (0.062)
Microbiological Assessments - Absolute Counts (10^5 bacterial cells) [Mean (Standard Deviation) ]
Actinomyces species	3.206 (1.7377)	3.319 (1.8306)	3.262 (1.7747)
Purple complex	2.207 (1.7989)	2.181 (1.888)	2.194 (1.5193)
Yellow complex	2.400 (2.2929)	2.535 (1.5893)	2.467 (1.9664)
Green complex	7.988 (8.8495)	6.841 (6.5277)	7.421 (7.7653)
Orange complex	5.252 (3.6072)	4.923 (3.6457)	5.089 (3.6089)
Red complex	1.638 (0.8182)	1.509 (0.8192)	1.574 (0.8165)
Other species	7.646 (6.1549)	7.322 (6.2088)	7.486 (6.1477)
Microbiological Assessments - LOG Counts (LOG counts of bacterial cells) [Mean (Standard Deviation) ]
Actinomyces species	5.410 (0.3647)	5.440 (0.2935)	5.425 (0.3298)
Purple complex	5.213 (0.3985)	5.255 (0.3107)	5.234 (0.3563)
Yellow complex	5.249 (0.3433)	5.302 (0.3284)	5.275 (0.3351)
Green complex	5.717 (0.4232)	5.660 (0.4038)	5.689 (0.4123)
Orange complex	5.603 (0.3506)	5.583 (0.3226)	5.593 (0.3352)
Red complex	5.149 (0.2624)	5.110 (0.2584)	5.130 (0.2596)
Other species	5.756 (0.3524)	5.722 (0.3660)	5.739 (0.3575)

Outcome Measures

1. Primary Outcome

Title	Whole-mouth Mean Modified Gingival Index (MGI)
Description	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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.

Arm/Group Title	5% Hydroalcohol Mouthrinse	0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
Arm/Group Description	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.	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.
Measure Participants	43	43
Mean (Standard Deviation) [Units on a scale]	2.199 (0.0934)	1.948 (0.1548)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	5% Hydroalcohol Mouthrinse, 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
	Comments
	Type of Statistical Test	Superiority
	Comments	The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	Terms for treatment as a factor & baseline as a covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.234
	Confidence Interval	(2-Sided) 95%; -0.276 to -0.192
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0211
	Estimation Comments

2. Primary Outcome

Title	Whole-mouth Mean Plaque Index (PI)
Description	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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.

Arm/Group Title	5% Hydroalcohol Mouthrinse	0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
Arm/Group Description	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.	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.
Measure Participants	43	43
Mean (Standard Deviation) [Units on a scale]	2.922 (0.1953)	1.634 (0.5724)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	5% Hydroalcohol Mouthrinse, 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
	Comments
	Type of Statistical Test	Superiority
	Comments	The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	Terms for treatment as a factor & baseline as a covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.232
	Confidence Interval	(2-Sided) 95%; -1.392 to -1.071
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0806
	Estimation Comments

3. Secondary Outcome

Title	Whole-mouth Mean Modified Gingival Index (MGI)
Description	Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index, where 0=Normal and 4=Severe Inflammation.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat population was used for analysis.

Arm/Group Title	5% Hydroalcohol Mouthrinse	0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
Arm/Group Description	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.	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.
Measure Participants	44	43
Mean (Standard Deviation) [Units on a scale]	2.189 (0.1014)	2.067 (0.1185)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	5% Hydroalcohol Mouthrinse, 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
	Comments
	Type of Statistical Test	Superiority
	Comments	The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	Terms for treatment as a factor & baseline as a covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.106
	Confidence Interval	(2-Sided) 95%; -0.140 to -0.071
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0173
	Estimation Comments

4. Secondary Outcome

Title	Whole-mouth Mean Plaque Index (PI)
Description	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.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

The intent-to-treat population was used for analysis.

Arm/Group Title	5% Hydroalcohol Mouthrinse	0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
Arm/Group Description	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.	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.
Measure Participants	44	43
Mean (Standard Deviation) [Units on a scale]	2.880 (0.2678)	1.987 (0.6539)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	5% Hydroalcohol Mouthrinse, 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
	Comments
	Type of Statistical Test	Superiority
	Comments	The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	Terms for treatment as a factor & baseline as a covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.830
	Confidence Interval	(2-Sided) 95%; -1.020 to -0.639
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0957
	Estimation Comments

5. Secondary Outcome

Title	Whole-mouth Mean Bleeding Index (BI)
Description	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.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

Intent to treat population was analyzed.

Arm/Group Title	5% Hydroalcohol Mouthrinse	0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
Arm/Group Description	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.	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.
Measure Participants	44	43
Mean (Standard Deviation) [Units on a scale]	0.123 (0.0569)	0.074 (0.0528)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	5% Hydroalcohol Mouthrinse, 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
	Comments
	Type of Statistical Test	Superiority
	Comments	The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	Terms for treatment as a factor & baseline as a covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.044
	Confidence Interval	(2-Sided) 95%; -0.059 to -0.029
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0076
	Estimation Comments

6. Secondary Outcome

Title	Whole-mouth Mean Bleeding Index (BI)
Description	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.
Time Frame	4 Weeks

Outcome Measure Data

Analysis Population Description

Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.

Arm/Group Title	5% Hydroalcohol Mouthrinse	0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
Arm/Group Description	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.	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.
Measure Participants	43	43
Mean (Standard Deviation) [Units on a scale]	0.120 (0.0524)	0.057 (0.0520)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	5% Hydroalcohol Mouthrinse, 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
	Comments
	Type of Statistical Test	Superiority
	Comments	The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments	Terms for treatment as a factor & baseline as a covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.060
	Confidence Interval	(2-Sided) 95%; -0.078 to -0.043
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0087
	Estimation Comments

7. Secondary Outcome

Title	Microbiological Assessments - Absolute Counts
Description	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
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.

Arm/Group Title	5% Hydroalcohol Mouthrinse	0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
Arm/Group Description	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.	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.
Measure Participants	43	43
Actinomyces species	1.868 (1.5514)	1.847 (1.2609)
Purple complex	0.910 (0.9723)	0.663 (0.6454)
Yellow complex	1.050 (0.8595)	1.018 (0.7001)
Green complex	4.530 (3.8225)	3.174 (2.4853)
Orange complex	3.562 (3.1562)	3.602 (2.4298)
Red complex	1.346 (1.0472)	1.111 (0.6017)
Other Species	4.471 (3.9108)	3.385 (2.3474)

8. Secondary Outcome

Title	Microbiological Assessments - LOG Counts
Description	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
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.

Arm/Group Title	5% Hydroalcohol Mouthrinse	0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
Arm/Group Description	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.	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.
Measure Participants	43	43
Actinomyces species	5.089 (0.4432)	5.154 (0.3491)
Purple complex	4.721 (0.5443)	4.617 (0.4546)
Yellow complex	4.882 (0.3674)	4.915 (0.2855)
Green complex	5.477 (0.4354)	5.400 (0.2935)
Orange complex	5.401 (0.3761)	5.461 (0.3008)
Red complex	5.012 (0.3354)	4.977 (0.2637)
Other Species	5.509 (0.3637)	5.433 (0.3005)

Adverse Events

Time Frame	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,
Arm/Group Title	5% Hydroalcohol Mouthrinse		0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
Arm/Group Description	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.		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.
All Cause Mortality
	5% Hydroalcohol Mouthrinse		0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/43 (0%)
Serious Adverse Events
	5% Hydroalcohol Mouthrinse		0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/44 (2.3%)		0/43 (0%)
Reproductive system and breast disorders
Testicular Swelling	1/44 (2.3%)	1	0/43 (0%)	0
Other (Not Including Serious) Adverse Events
	5% Hydroalcohol Mouthrinse		0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/43 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.