Gingivitis, Plaque
Conditions
Brief summary
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.
Interventions
DRUGArm & Hammer Advance White Brilliant Sparkle (Test product)
20% sodium bicarbonate
DRUGCrest Cavity Protection Regular Toothpaste (Negative Control)
Negative control
Sponsors
Church & Dwight Company, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Have provided written informed consent prior to being entered into study * Have at least 18 scorable natural teeth as determined by the examiner * Have a mean baseline plaque index score greater than or equal to 2.0 as determined by the Soparkar Modification of the Turesky modification of the Quigley-Hein Plaque Index * Have a mean baseline gingival index score of greater than 1.80 as determined by the Modified Gingival Index * Presence of greater than 10 bleeding sites upon probing * Agree not to have dental prophylaxis or any other elective, no -emergency dental procedures (other than those provided during the study) any time during the study * Agree to abstain from use of floss, chewing gum, mouth rinses, any toothpaste other than the study toothpaste, tooth whitening products (either professional or at home use) and all other oral hygiene other than the study procedures for the duration of the study. * Agree to refrain from all oral hygiene on the morning of each evaluation visit and to refrain from eating and drinking for 4 hours prior to each evaluation visit * Agree to comply with the conditions and schedule of the study
Exclusion criteria
* Physical limitations or restrictions that might preclude normal tooth brushing * Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or soft or hard tissue tumor of the oral cavity. * Heavy calculus that might interfere with evaluations as determined by the Investigator/Examiner * Chronic disease with concomitant oral manifestations * Conditions requiring antibiotic prophylaxis prior to invasive procedures, such as heart murmur, history of rheumatic fever, valvular disease or certain prosthetic implants * History of uncontrolled diabetes or hepatic or renal disease, or other serious conditions or transmittable diseases (eg cardiovascular disease, AIDS) * Subjects with fixed or removable orthodontic appliances or removable partial dentures * Subjects who are currently undergoing, or require, extensive dental work or orthodontic treatment * Treatment with antibiotics within the 1-month period before the baseline examination, or a condition that is likely to require antibiotic treatment over the course of the trial * Chronic treatment (2 weeks or more) with any medication known to affect periodontal status (including phenytoin, calcium antagonists, cyclosporine, coumarin, nonsteroidal anti-inflammatory drugs, and aspirin) within 1 month of baseline examination. All other medications for chronic medical conditions must have been initiated at least 3 months before enrollment * Moderately advanced to advanced periodontitis as indicated by clinical attachment loss, radiographic alveolar bone loss, and/or periodontal pockets greater than 5 millimeters * Having history of early-onset periodontitis or acute necrotizing ulcerative gingivitis * Concomitant endodontic or periodontal therapy other than prophylaxis in the last 6 months * Professional prophylaxis within 1 month prior to the baseline clinical evaluation * Currently using bleaching trays * Currently using power toothbrush * Currently a smoker or recently (during the past 6 months) quit smoking * Having any oral piercings in or around the oral cavity with ornament or accessory * Regular use of any chemotherapeutic antiplaque/antigingivitis products such as Colgate Total, Crest Pro-Health, Listerine, etc * History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses * Subjects who are nursing, pregnant or plan to become pregnant for the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy | 16 weeks | 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. |
| Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy | 16 weeks | 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. |
| Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy | 16 weeks | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 78 |
| 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 | 78 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not meet enrollment criteria | 9 | 13 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Arm & Hammer Advance White Brilliant Sparkle (Test Product) | Crest Cavity Protection Regular Toothpaste (Negative Control) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants | 78 Participants | 156 Participants |
| Gingival Bleeding Efficacy | .228 units on a scale STANDARD_DEVIATION 0.046 | .230 units on a scale STANDARD_DEVIATION 0.044 | .229 units on a scale STANDARD_DEVIATION 0.045 |
| Gingvial Efficacy | 2.039 units on a scale STANDARD_DEVIATION 0.053 | 2.039 units on a scale STANDARD_DEVIATION 0.057 | 2.039 units on a scale STANDARD_DEVIATION 0.055 |
| Plaque Efficacy | 2.575 units on a scale STANDARD_DEVIATION 0.295 | 2.534 units on a scale STANDARD_DEVIATION 0.248 | 2.555 units on a scale STANDARD_DEVIATION 0.272 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 56 Participants | 51 Participants | 107 Participants |
| Sex: Female, Male Male | 22 Participants | 27 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 88 | 0 / 93 |
| serious Total, serious adverse events | 0 / 88 | 0 / 93 |
Outcome results
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.
Time frame: 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm & Hammer Advance White Brilliant Sparkle (Test Product) | Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy | 4 weeks | .134 units on a scale | Standard Deviation 0.055 |
| Arm & Hammer Advance White Brilliant Sparkle (Test Product) | Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy | 8 weeks | .162 units on a scale | Standard Deviation 0.042 |
| Arm & Hammer Advance White Brilliant Sparkle (Test Product) | Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy | 12 weeks | .190 units on a scale | Standard Deviation 0.045 |
| Arm & Hammer Advance White Brilliant Sparkle (Test Product) | Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy | 16 weeks | .180 units on a scale | Standard Deviation 0.043 |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy | 16 weeks | .144 units on a scale | Standard Deviation 0.056 |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy | 4 weeks | .119 units on a scale | Standard Deviation 0.056 |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy | 12 weeks | .162 units on a scale | Standard Deviation 0.056 |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy | 8 weeks | .145 units on a scale | Standard Deviation 0.039 |
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.
Time frame: 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm & Hammer Advance White Brilliant Sparkle (Test Product) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy | 4 weeks | .230 units on a scale | Standard Deviation 0.105 |
| Arm & Hammer Advance White Brilliant Sparkle (Test Product) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy | 8 weeks | .3701 units on a scale | Standard Deviation 0.13 |
| Arm & Hammer Advance White Brilliant Sparkle (Test Product) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy | 12 weeks | .444 units on a scale | Standard Deviation 0.139 |
| Arm & Hammer Advance White Brilliant Sparkle (Test Product) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy | 16 weeks | .330 units on a scale | Standard Deviation 0.118 |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy | 16 weeks | .157 units on a scale | Standard Deviation 0.084 |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy | 4 weeks | .155 units on a scale | Standard Deviation 0.123 |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy | 12 weeks | .214 units on a scale | Standard Deviation 0.11 |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy | 8 weeks | .205 units on a scale | Standard Deviation 0.077 |
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.
Time frame: 16 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm & Hammer Advance White Brilliant Sparkle (Test Product) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy | 4 weeks | .648 units on a scale | Standard Deviation 0.327 |
| Arm & Hammer Advance White Brilliant Sparkle (Test Product) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy | 8 weeks | .776 units on a scale | Standard Deviation 0.369 |
| Arm & Hammer Advance White Brilliant Sparkle (Test Product) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy | 12 weeks | .765 units on a scale | Standard Deviation 0.295 |
| Arm & Hammer Advance White Brilliant Sparkle (Test Product) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy | 16 weeks | .275 units on a scale | Standard Deviation 0.378 |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy | 16 weeks | .275 units on a scale | Standard Deviation 0.378 |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy | 4 weeks | .468 units on a scale | Standard Deviation 0.264 |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy | 12 weeks | .533 units on a scale | Standard Deviation 0.332 |
| Crest Cavity Protection Regular Toothpaste (Negative Control) | Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy | 8 weeks | .574 units on a scale | Standard Deviation 0.283 |