Compare Anti-inflammatory Dentifrices
Overview
- Phase
- Phase 4
- Intervention
- Triclosan/Copolymer/fluoride toothpaste
- Conditions
- Gingivitis
- Sponsor
- Colgate Palmolive
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Nuclear Factor Kappa B Ligand (RANK-L)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Plaque induced gingivitis
Investigators
Eligibility Criteria
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
Arms & Interventions
Total Toothpaste
Triclosan/Copolymer/fluoride toothpaste
Intervention: Triclosan/Copolymer/fluoride toothpaste
Fluoride toothpaste
sodium monofluorophosphate toothpaste
Intervention: Sodium monofluorophosphate toothpaste
Outcomes
Primary Outcomes
Nuclear Factor Kappa B Ligand (RANK-L)
Time Frame: 29 days
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.
8-iso-prostaglandinF2α (8-iso-PGF2α)
Time Frame: 29 days
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.
Gingival Index (GI)
Time Frame: 29 days
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
Prostaglandin E2 (PGE2)
Time Frame: 29 days
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.
Interleukin - 1 Beta (IL-ß)
Time Frame: 29 days
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.
Interleukin-6 (IL-6)
Time Frame: 29 days
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.
Secondary Outcomes
- Dental Plaque Index (PI)(29 days)
- Bleeding on Probing (BOP)(29 days)