Clinical Evaluation of the Efficacy of a Marketed Dentifrice on Plaque and Gingivitis

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of the Efficacy of a Marketed Dentifrice on Plaque and Gingivitis

Conditions
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Plaque, Gingivitis

Intervention / Treatment
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* Drug: Arm & Hammer Advance White Brilliant Sparkle (Test product)
* Drug: Crest Cavity Protection Regular Toothpaste (Negative Control)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm & Hammer Advance White Brilliant Sparkle (Test product)<br>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. | Drug: Arm & Hammer Advance White Brilliant Sparkle (Test product)<br>* 20% sodium bicarbonate<br>|
| Active Comparator: Crest Cavity Protection Regular Toothpaste (Negative Control)<br>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. | Drug: Crest Cavity Protection Regular Toothpaste (Negative Control)<br>* Negative control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |