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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.15% ethyl lauroyl arginate HCl-containing mouthrinse | Experimental | 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. |
|
| 5% hydroalcohol mouthrinse | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 19416-154-1 | Device | 0.15% ethyl lauroyl arginate HCl-containing mouthrinse |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Whole-mouth Mean Plaque Index (PI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo Araujo, DDS, MS, PhD | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioSci Research Inc. | Las Vegas | Nevada | 89121 | United States |
Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 0.15% Ethyl Lauroyl Arginate HCl-containing Mouthrinse |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
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,
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Testicular Swelling | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Lynch | Johnson & Johnson Consumer Inc. | 908-433-6423 | mlynch23@ITS.JNJ.com |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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| W002194-0221P | Device | 5% hydroalcohol mouthrinse |
|
|
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.
| 2 Weeks |
| 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. | 2 Weeks |
| 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. | 4 Weeks |
| 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:
| 4 weeks |
| 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:
| 4 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Smoker | Number of participants who smoke | Count of Participants | Participants |
|
| Smokeless Tabacco Use | Number of Participants who use smokeless tobacco | Count of Participants | Participants |
|
| Mean Plaque Index - Whole Mouth | 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. | Mean | Standard Deviation | Units on a scale |
|
| Modified Gingival Index - Whole Mouth | 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 | Mean | Standard Deviation | Units on a scale |
|
| Gingival Bleeding Index - Whole Mouth | 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. | Mean | Standard Deviation | Units on a scale |
|
| Microbiological Assessments - Absolute Counts | A checkerboard DNA-DNA hybridization was conducted to estimate the # of bacterial cells in plaque samples. DNA from lysed bacteria cells was detected using fluorescent probes for different bacterial species. The sensitivity of the assay was 10^4 cells; failure to detect a signal was recorded as 0. Signals were converted to absolute counts by comparison with fluorescent signals 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 | Mean | Standard Deviation | 10^5 bacterial cells |
|
| Microbiological Assessments - LOG Counts | A checkerboard DNA-DNA hybridization was conducted to estimate the # of bacterial cells in plaque samples. DNA from lysed bacteria cells was detected using fluorescent probes for different bacterial species. The sensitivity of the assay was 10^4 cells; failure to detect a signal was recorded as 0. Signals were converted to log counts by comparison with fluorescent signals 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 | Mean | Standard Deviation | LOG counts of bacterial cells |
|
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.
|
|
|
| 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. | Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
|
| 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. | Intent to treat population was used for analysis. | Posted | Mean | Standard Deviation | Units on a scale | 2 weeks |
|
|
|
|
| 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. | The intent-to-treat population was used for analysis. | Posted | Mean | Standard Deviation | Units on a scale | 2 Weeks |
|
|
|
|
| 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. | Intent to treat population was analyzed. | Posted | Mean | Standard Deviation | Units on a scale | 2 Weeks |
|
|
|
|
| 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. | Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4. | Posted | Mean | Standard Deviation | Units on a scale | 4 Weeks |
|
|
|
|
| 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:
| Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4. | Posted | Mean | Standard Deviation | 10^5 bacterial cells | 4 weeks |
|
|
|
| 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:
| Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4. | Posted | Mean | Standard Deviation | LOG counts of bacterial cells | 4 weeks |
|
|
|
| 0 |
| 44 |
| 1 |
| 44 |
| 0 |
| 44 |
| EG001 | 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. | 0 | 43 | 0 | 43 | 0 | 43 |
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.
| D005882 |
| Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| Yellow complex |
|
| Green complex |
|
| Orange complex |
|
| Red complex |
|
| Other Species |
|
| Yellow complex |
|
| Green complex |
|
| Orange complex |
|
| Red complex |
|
| Other Species |
|