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Parallel, double blind, randomized, Institutional Review Board (IRB) -approved study involving approximately 160 subjects to complete. Subjects were randomly assigned to either the test product (Arm & Hammer Advance White Brilliant Sparkle) or the control (Crest Cavity Protection Regular) based on baseline mean whole-mouth plaque and gingival scores and age.Subjects brushed with their assigned dentifrice two times (2X) daily and were evaluated for gingivitis, bleeding and plaque at Baseline and after 4-, 8-, and 12-weeks of product use. Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm & Hammer Advance White Brilliant Sparkle (Test product) | Experimental | 2X daily brushing for 12 weeks with Arm & Hammer Advance White Brilliant Sparkle (Test product). Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks. |
|
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Active Comparator | 2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control). Return to pre-study hygiene regimen for 4 weeks and final evaluation at 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm & Hammer Advance White Brilliant Sparkle (Test product) | Drug | 20% sodium bicarbonate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy | change in score as measured by Gingival Index (0=absence of inflammation, 1=mild inflammation: slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit, 2=mild inflammation: slight change in color, little change in texture to entire marginal or papillary gingival unit, 3=moderate inflammation: glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit, 4=severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The scale ranges from 0-4. | 16 weeks |
| Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy | change in score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2. | 16 weeks |
| Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy | change in score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown. The scale ranges from 0-5. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioSci Research Canada, Ltd | Mississauga | Ontario | L5N 1A4 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm & Hammer Advance White Brilliant Sparkle (Test Product) | 2X daily brushing for 12 weeks with Arm & Hammer Advance White Brilliant Sparkle (Test product) Arm & Hammer Advance White Brilliant Sparkle (Test product): 20% sodium bicarbonate |
| FG001 | Crest Cavity Protection Regular Toothpaste (Negative Control) | 2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control) Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm & Hammer Advance White Brilliant Sparkle (Test Product) | 2X daily brushing for 12 weeks with Arm & Hammer Advance White Brilliant Sparkle (Test product) Arm & Hammer Advance White Brilliant Sparkle (Test product): 20% sodium bicarbonate |
| BG001 | Crest Cavity Protection Regular Toothpaste (Negative Control) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy | change in score as measured by Gingival Index (0=absence of inflammation, 1=mild inflammation: slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit, 2=mild inflammation: slight change in color, little change in texture to entire marginal or papillary gingival unit, 3=moderate inflammation: glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit, 4=severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The scale ranges from 0-4. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
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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 | Arm & Hammer Advance White Brilliant Sparkle (Test Product) | 2X daily brushing for 12 weeks with Arm & Hammer Advance White Brilliant Sparkle (Test product) Arm & Hammer Advance White Brilliant Sparkle (Test product): 20% sodium bicarbonate |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annahita Ghassemi | Church & Dwight Co., Inc | 6098061200 | annahita.ghassemi@churchdwight.com |
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| ID | Term |
|---|---|
| D058225 | Plaque, Amyloid |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D005882 | Gingival Diseases |
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| Crest Cavity Protection Regular Toothpaste (Negative Control) | Drug | Negative control |
|
| Lost to Follow-up |
|
2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control) Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Gingvial Efficacy | Lobene Modified Loe-Silness Gingival Scoring Index (MGI) - gingival sites were visually scored at each visit on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth, using a scale of 0-4. Lower values represent a better outcome. | Mean | Standard Deviation | units on a scale |
|
| Gingival Bleeding Efficacy | Bleeding was assessed on all scorable buccal and lingual surfaces by inserting a periodontal probe into the gingival crevice and sweeping from the distal aspect to the mesial aspect around the tooth at a depth of approximately 1 mm and angle of approximately 60 degrees while in contact with the sulcular epithelium. Three areas (distobuccal, midbuccal and midlingual) were assessed around each tooth. Sites were scored at each visit using the Gingival Bleeding Index (GBI) as defined by Saxton and van der Ouderaa on a scale of 0-2. Lower values represent a better outcome. | Mean | Standard Deviation | units on a scale |
|
| Plaque Efficacy | Plaque was scored at each visit using the Soparker modification of the Turesky Modification of the Quigley-Hein Plaque Index (PI) on all scorable buccal and lingual surfaces. Plaque was stained with disclosant and each tooth was divided into six areas for scoring on a scale of 0-5. A PI score for each subject was calculated by adding all individual site scores (6 per tooth) and dividing by the total number of sites scored (teeth x 6). Lower values represent a better outcome. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Crest Cavity Protection Regular Toothpaste (Negative Control) | 2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control) Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control |
|
|
| Primary | Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy | change in score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
|
|
| Primary | Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy | change in score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown. The scale ranges from 0-5. | Posted | Mean | Standard Deviation | units on a scale | 16 weeks |
|
|
|
| 0 |
| 88 |
| 0 |
| 88 |
| EG001 | Crest Cavity Protection Regular Toothpaste (Negative Control) | 2X daily brushing for 12 weeks with Crest Cavity Protection Regular Toothpaste (Negative Control) Crest Cavity Protection Regular Toothpaste (Negative Control): Negative control | 0 | 93 | 0 | 93 |
Confidentiality agreement in place with Investigator.
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| 12 weeks |
|
| 16 weeks |
|
| 12 weeks |
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| 16 weeks |
|