Clinical Efficacy Evaluation of Three Dentifrices

Study Overview
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Brief Summary
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Clinical study to evaluate and compare the efficacy of two baking soda containing dentifrices, containing 20% and 35% baking soda, to a non-baking soda dentifrice for their ability to reduce gingivitis and plaque following 6-months of use.

Official Title
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Clinical Efficacy Evaluation of Three Dentifrices Containing 35%, 20%, and 0% Sodium Bicarbonate on the Reduction of Plaque and Gingivitis

Conditions
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Gingival Inflammation and Bleeding, Dental Plaque

Intervention / Treatment
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* Drug: Dentifrices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have provided written informed consent prior to being entered into the study. Be between 18 and 70 years of age, male or female. Have at least eighteen (18) natural teeth with scorable facial and lingual surfaces as determined by the Examiner. Teeth that are grossly carious, orthodontically banded, exhibiting general cervical abrasion and/or enamel abrasion, or third molars will not be included in the tooth count. Have a mean baseline plaque index score ≥ 1.95 as determined by the Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index (Pl). Have a mean baseline gingival index score of ≥ l.70 and ≤ 3.0 as determined by the Modified Gingival Index (MGI). Presence of ≥ 10 bleeding sites upon probing. Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures any time during the study. Agree to abstain from the use of 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, drinking, and smoking for 4 hrs, 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, preexisting gross plaque or soft or hard tissue tumor of the oral cavity. Heavy supra- or subgingival calculus that might interfere with evaluations as determined by the Investigator/Examiner. Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner. Conditions requiring antibiotic treatment prior to dental procedures. History of uncontrolled diabetes or hepatic or renal disease, or other serious conditions or transmittable diseases, (e.g. cardiovascular disease, AIDS). Subjects with grossly carious, fully crowned, or extensively restored teeth, orthodontic appliances, peri/oral piercings, or removable partial dentures. 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 the baseline examination. All other medications for chronic medical conditions must have been initiated at least 3 months before enrollment. Have severe periodontal disease or being actively treated for periodontal disease. Having history of early-onset periodontitis or acute necrotizing ulcerative gingivitis. Concomitant periodontal therapy other than prophylaxis in the last 6 months. Professional prophylaxis within 1 month prior to the baseline clinical evaluation. Subjects who participated in a gingivitis study in the past month. Daily use of chemotherapeutic antiplaque/antigingivitis products within the past 4 months. History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Subjects who are allergic to any ingredients in the test or control product, as listed on the IRB Safety Assessment. Self-reported pregnancy and nursing since hormonal changes can exaggerate gingival response to dental plaque.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Active Comparator: 0% Baking Soda Dentifrice<br> | Drug: Dentifrices<br>* Dentifrice on plaque, gingivitis, and bleeding.<br>|
| Active Comparator: 20% Baking Soda Dentifrice<br> | Drug: Dentifrices<br>* Dentifrice on plaque, gingivitis, and bleeding.<br>|
| Active Comparator: 35% Baking Soda Dentifrice<br> | Drug: Dentifrices<br>* Dentifrice on plaque, gingivitis, and bleeding.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | Mean Within-Treatment Whole-Mouth 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. | baseline, six weeks, 3 months and 6 months | 
| Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | Mean Within-Treatment Whole-Mouth 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. | baseline, six week, three months, and six months | 
| Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | Mean Within-Treatment Whole-Mouth 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. | baseline, six weeks, three months, and six months |