Dental Plaque
Conditions
Keywords
Gingivitis, Microorganisms
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.
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.
Interventions
DEVICE19416-154-1
0.15% ethyl lauroyl arginate HCl-containing mouthrinse
DEVICEW002194-0221P
5% hydroalcohol mouthrinse
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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 |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| 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. | 43 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Total | 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | 5% Hydroalcohol Mouthrinse |
|---|---|---|---|
| Age, Continuous | 34.8 years STANDARD_DEVIATION 9.26 | 34.0 years STANDARD_DEVIATION 8.05 | 35.6 years STANDARD_DEVIATION 10.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 6 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 37 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gingival Bleeding Index - Whole Mouth | 0.133 Units on a scale STANDARD_DEVIATION 0.062 | 0.129 Units on a scale STANDARD_DEVIATION 0.0634 | 0.137 Units on a scale STANDARD_DEVIATION 0.0614 |
| Mean Plaque Index - Whole Mouth | 2.961 Units on a scale STANDARD_DEVIATION 0.257 | 2.926 Units on a scale STANDARD_DEVIATION 0.2866 | 2.996 Units on a scale STANDARD_DEVIATION 0.2222 |
| Microbiological Assessments - Absolute Counts Actinomyces species | 3.262 10^5 bacterial cells STANDARD_DEVIATION 1.7747 | 3.319 10^5 bacterial cells STANDARD_DEVIATION 1.8306 | 3.206 10^5 bacterial cells STANDARD_DEVIATION 1.7377 |
| Microbiological Assessments - Absolute Counts Green complex | 7.421 10^5 bacterial cells STANDARD_DEVIATION 7.7653 | 6.841 10^5 bacterial cells STANDARD_DEVIATION 6.5277 | 7.988 10^5 bacterial cells STANDARD_DEVIATION 8.8495 |
| Microbiological Assessments - Absolute Counts Orange complex | 5.089 10^5 bacterial cells STANDARD_DEVIATION 3.6089 | 4.923 10^5 bacterial cells STANDARD_DEVIATION 3.6457 | 5.252 10^5 bacterial cells STANDARD_DEVIATION 3.6072 |
| Microbiological Assessments - Absolute Counts Other species | 7.486 10^5 bacterial cells STANDARD_DEVIATION 6.1477 | 7.322 10^5 bacterial cells STANDARD_DEVIATION 6.2088 | 7.646 10^5 bacterial cells STANDARD_DEVIATION 6.1549 |
| Microbiological Assessments - Absolute Counts Purple complex | 2.194 10^5 bacterial cells STANDARD_DEVIATION 1.5193 | 2.181 10^5 bacterial cells STANDARD_DEVIATION 1.888 | 2.207 10^5 bacterial cells STANDARD_DEVIATION 1.7989 |
| Microbiological Assessments - Absolute Counts Red complex | 1.574 10^5 bacterial cells STANDARD_DEVIATION 0.8165 | 1.509 10^5 bacterial cells STANDARD_DEVIATION 0.8192 | 1.638 10^5 bacterial cells STANDARD_DEVIATION 0.8182 |
| Microbiological Assessments - Absolute Counts Yellow complex | 2.467 10^5 bacterial cells STANDARD_DEVIATION 1.9664 | 2.535 10^5 bacterial cells STANDARD_DEVIATION 1.5893 | 2.400 10^5 bacterial cells STANDARD_DEVIATION 2.2929 |
| Microbiological Assessments - LOG Counts Actinomyces species | 5.425 LOG counts of bacterial cells STANDARD_DEVIATION 0.3298 | 5.440 LOG counts of bacterial cells STANDARD_DEVIATION 0.2935 | 5.410 LOG counts of bacterial cells STANDARD_DEVIATION 0.3647 |
| Microbiological Assessments - LOG Counts Green complex | 5.689 LOG counts of bacterial cells STANDARD_DEVIATION 0.4123 | 5.660 LOG counts of bacterial cells STANDARD_DEVIATION 0.4038 | 5.717 LOG counts of bacterial cells STANDARD_DEVIATION 0.4232 |
| Microbiological Assessments - LOG Counts Orange complex | 5.593 LOG counts of bacterial cells STANDARD_DEVIATION 0.3352 | 5.583 LOG counts of bacterial cells STANDARD_DEVIATION 0.3226 | 5.603 LOG counts of bacterial cells STANDARD_DEVIATION 0.3506 |
| Microbiological Assessments - LOG Counts Other species | 5.739 LOG counts of bacterial cells STANDARD_DEVIATION 0.3575 | 5.722 LOG counts of bacterial cells STANDARD_DEVIATION 0.366 | 5.756 LOG counts of bacterial cells STANDARD_DEVIATION 0.3524 |
| Microbiological Assessments - LOG Counts Purple complex | 5.234 LOG counts of bacterial cells STANDARD_DEVIATION 0.3563 | 5.255 LOG counts of bacterial cells STANDARD_DEVIATION 0.3107 | 5.213 LOG counts of bacterial cells STANDARD_DEVIATION 0.3985 |
| Microbiological Assessments - LOG Counts Red complex | 5.130 LOG counts of bacterial cells STANDARD_DEVIATION 0.2596 | 5.110 LOG counts of bacterial cells STANDARD_DEVIATION 0.2584 | 5.149 LOG counts of bacterial cells STANDARD_DEVIATION 0.2624 |
| Microbiological Assessments - LOG Counts Yellow complex | 5.275 LOG counts of bacterial cells STANDARD_DEVIATION 0.3351 | 5.302 LOG counts of bacterial cells STANDARD_DEVIATION 0.3284 | 5.249 LOG counts of bacterial cells STANDARD_DEVIATION 0.3433 |
| Modified Gingival Index - Whole Mouth | 2.184 Units on a scale STANDARD_DEVIATION 0.106 | 2.172 Units on a scale STANDARD_DEVIATION 0.1132 | 2.196 Units on a scale STANDARD_DEVIATION 0.0989 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 9 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 8 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 26 Participants | 23 Participants |
| Sex: Female, Male Female | 53 Participants | 30 Participants | 23 Participants |
| Sex: Female, Male Male | 34 Participants | 13 Participants | 21 Participants |
| Smokeless Tabacco Use No | 86 Participants | 43 Participants | 43 Participants |
| Smokeless Tabacco Use Yes | 1 Participants | 0 Participants | 1 Participants |
| Smoker No | 77 Participants | 37 Participants | 40 Participants |
| Smoker Yes | 10 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 43 |
| other Total, other adverse events | 0 / 44 | 0 / 43 |
| serious Total, serious adverse events | 1 / 44 | 0 / 43 |
Outcome results
Primary
Whole-mouth Mean Modified Gingival Index (MGI)
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
Population: Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5% Hydroalcohol Mouthrinse | Whole-mouth Mean Modified Gingival Index (MGI) | 2.199 Units on a scale | Standard Deviation 0.0934 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Whole-mouth Mean Modified Gingival Index (MGI) | 1.948 Units on a scale | Standard Deviation 0.1548 |
p-value: <0.00195% CI: [-0.276, -0.192]ANCOVA
Primary
Whole-mouth Mean Plaque Index (PI)
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
Population: Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5% Hydroalcohol Mouthrinse | Whole-mouth Mean Plaque Index (PI) | 2.922 Units on a scale | Standard Deviation 0.1953 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Whole-mouth Mean Plaque Index (PI) | 1.634 Units on a scale | Standard Deviation 0.5724 |
p-value: <0.00195% CI: [-1.392, -1.071]ANCOVA
Secondary
Microbiological Assessments - Absolute Counts
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
Population: Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - Absolute Counts | Yellow complex | 1.050 10^5 bacterial cells | Standard Deviation 0.8595 |
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - Absolute Counts | Orange complex | 3.562 10^5 bacterial cells | Standard Deviation 3.1562 |
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - Absolute Counts | Purple complex | 0.910 10^5 bacterial cells | Standard Deviation 0.9723 |
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - Absolute Counts | Red complex | 1.346 10^5 bacterial cells | Standard Deviation 1.0472 |
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - Absolute Counts | Green complex | 4.530 10^5 bacterial cells | Standard Deviation 3.8225 |
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - Absolute Counts | Other Species | 4.471 10^5 bacterial cells | Standard Deviation 3.9108 |
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - Absolute Counts | Actinomyces species | 1.868 10^5 bacterial cells | Standard Deviation 1.5514 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - Absolute Counts | Other Species | 3.385 10^5 bacterial cells | Standard Deviation 2.3474 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - Absolute Counts | Actinomyces species | 1.847 10^5 bacterial cells | Standard Deviation 1.2609 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - Absolute Counts | Purple complex | 0.663 10^5 bacterial cells | Standard Deviation 0.6454 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - Absolute Counts | Yellow complex | 1.018 10^5 bacterial cells | Standard Deviation 0.7001 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - Absolute Counts | Green complex | 3.174 10^5 bacterial cells | Standard Deviation 2.4853 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - Absolute Counts | Orange complex | 3.602 10^5 bacterial cells | Standard Deviation 2.4298 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - Absolute Counts | Red complex | 1.111 10^5 bacterial cells | Standard Deviation 0.6017 |
Secondary
Microbiological Assessments - LOG Counts
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
Population: Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - LOG Counts | Yellow complex | 4.882 LOG counts of bacterial cells | Standard Deviation 0.3674 |
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - LOG Counts | Orange complex | 5.401 LOG counts of bacterial cells | Standard Deviation 0.3761 |
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - LOG Counts | Purple complex | 4.721 LOG counts of bacterial cells | Standard Deviation 0.5443 |
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - LOG Counts | Red complex | 5.012 LOG counts of bacterial cells | Standard Deviation 0.3354 |
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - LOG Counts | Green complex | 5.477 LOG counts of bacterial cells | Standard Deviation 0.4354 |
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - LOG Counts | Other Species | 5.509 LOG counts of bacterial cells | Standard Deviation 0.3637 |
| 5% Hydroalcohol Mouthrinse | Microbiological Assessments - LOG Counts | Actinomyces species | 5.089 LOG counts of bacterial cells | Standard Deviation 0.4432 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - LOG Counts | Other Species | 5.433 LOG counts of bacterial cells | Standard Deviation 0.3005 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - LOG Counts | Actinomyces species | 5.154 LOG counts of bacterial cells | Standard Deviation 0.3491 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - LOG Counts | Purple complex | 4.617 LOG counts of bacterial cells | Standard Deviation 0.4546 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - LOG Counts | Yellow complex | 4.915 LOG counts of bacterial cells | Standard Deviation 0.2855 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - LOG Counts | Green complex | 5.400 LOG counts of bacterial cells | Standard Deviation 0.2935 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - LOG Counts | Orange complex | 5.461 LOG counts of bacterial cells | Standard Deviation 0.3008 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Microbiological Assessments - LOG Counts | Red complex | 4.977 LOG counts of bacterial cells | Standard Deviation 0.2637 |
Secondary
Whole-mouth Mean Bleeding Index (BI)
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
Population: Intent to treat population was analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5% Hydroalcohol Mouthrinse | Whole-mouth Mean Bleeding Index (BI) | 0.123 Units on a scale | Standard Deviation 0.0569 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Whole-mouth Mean Bleeding Index (BI) | 0.074 Units on a scale | Standard Deviation 0.0528 |
p-value: <0.00195% CI: [-0.059, -0.029]ANCOVA
Secondary
Whole-mouth Mean Bleeding Index (BI)
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
Population: Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5% Hydroalcohol Mouthrinse | Whole-mouth Mean Bleeding Index (BI) | 0.120 Units on a scale | Standard Deviation 0.0524 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Whole-mouth Mean Bleeding Index (BI) | 0.057 Units on a scale | Standard Deviation 0.052 |
p-value: <0.00195% CI: [-0.078, -0.043]ANCOVA
Secondary
Whole-mouth Mean Modified Gingival Index (MGI)
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
Population: Intent to treat population was used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5% Hydroalcohol Mouthrinse | Whole-mouth Mean Modified Gingival Index (MGI) | 2.189 Units on a scale | Standard Deviation 0.1014 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Whole-mouth Mean Modified Gingival Index (MGI) | 2.067 Units on a scale | Standard Deviation 0.1185 |
p-value: <0.00195% CI: [-0.14, -0.071]ANCOVA
Secondary
Whole-mouth Mean Plaque Index (PI)
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
Population: The intent-to-treat population was used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5% Hydroalcohol Mouthrinse | Whole-mouth Mean Plaque Index (PI) | 2.880 Units on a scale | Standard Deviation 0.2678 |
| 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse | Whole-mouth Mean Plaque Index (PI) | 1.987 Units on a scale | Standard Deviation 0.6539 |
p-value: <0.00195% CI: [-1.02, -0.639]ANCOVA