Compare Anti-inflammatory Dentifrices

Study Overview
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Brief Summary
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Plaque induced gingivitis

Official Title
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Compare Anti-inflammatory Dentifrices

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: Triclosan/Copolymer/fluoride toothpaste
* Drug: Sodium monofluorophosphate toothpaste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be adult males or females 18 to 60 years old Subjects must be able and willing to follow study procedures and instructions Subjects must have read, understood and signed an informed consent form Subjects must have generalized, moderate plaque-associated gingivitis as determined by the Investigator or designee during the screening examination Subjects must present with at least 20 teeth in the functional dentition, excluding third molars Each subject must have at least four teeth with probing depths of 4-5 mm and at least 30% of sites bleeding to gentle probing Exclusion Criteria: Subjects who have chronically used (i.e., two weeks or more) Total (Triclosan/Copolymer) dentifrice within 6 months prior to enrollment Subjects with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity Subjects with periodontitis as indicated by periodontal pocketing 6 mm at screening Subjects with a history of early onset periodontitis or acute necrotizing ulcerative gingivitis Subjects with concomitant endodontic or periodontal therapy other than prophylaxis within 6 months prior to enrollment Subjects with orthodontic appliances or removable partial dentures Subjects chronically treated (two weeks or more) with any medication known to affect inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs, steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within one month of the screening examination. All other medications for chronic medical conditions should be initiated at least three months prior to enrollment Subjects who currently smoke or who report using tobacco products within one year of screening. Subjects who have been treated with antibiotics for medical or dental reasons within 3 months prior to enrollment Subjects having clinically significant or unstable organic disease; subjects having compromised healing potential such as those with diabetes mellitus or connective tissue disorders; subjects having heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis Female subjects who report being pregnant or lactating, or female subjects who are of childbearing potential and who report not using hormonal or barrier methods of birth control (oral or parenteral contraceptives, diaphragm plus spermicide, condoms) Subjects who use hormonal contraceptives must have started the method 30 days prior to the screening examination. Subjects with active infectious diseases such as hepatitis, human immunodeficiency virus or Tuberculosis Subjects diagnosed with human immunodeficiency virus (HIV) or subjects that are immunocompromised as determined by the Investigator Medical condition which precludes not eating/drinking for approximately 8 hours.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total Toothpaste<br>Triclosan/Copolymer/fluoride toothpaste | Drug: Triclosan/Copolymer/fluoride toothpaste<br>* Twice daily usage<br>* Other names: Toothpaste includes triclosan/fluoride/co-polymer (Total);|
| Placebo Comparator: Fluoride toothpaste<br>sodium monofluorophosphate toothpaste | Drug: Sodium monofluorophosphate toothpaste<br>* Twice daily usage<br>* Other names: fluoride only toothpaste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival Index (GI) | Gingival Index(GI)recorded on scale of 0-3 detailed below: 0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration & tendency to spontaneously bleed | 29 days | 
| Prostaglandin E2 (PGE2) | Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. | 29 days | 
| Interleukin - 1 Beta (IL-ß) | Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. | 29 days | 
| Interleukin-6 (IL-6) | Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. | 29 days | 
| Nuclear Factor Kappa B Ligand (RANK-L) | Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. | 29 days | 
| 8-iso-prostaglandinF2α (8-iso-PGF2α) | Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. | 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental Plaque Index (PI) | measurement of supragingival dental plaque on scale of 0-3. 0=No plaque in gingival area,1=a film of plaque adhering to the free gingival margin and the adjacent tooth,2=Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth-visible by the naked eye, 3=Abundance of soft matter within the gingival pocket and/or gingival margin and adjacent tooth surfaces. | 29 days | 
| Bleeding on Probing (BOP) | Presence or absence of bleeding to manual probing as a dichotomous variable as follows: 0 = No bleeding within 10 seconds after probing, 1 = Bleeding within 10 seconds after probing. | 29 days |