Compare Anti-inflammatory Dentifrices | NCT00762528

NCT00762528

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Total Toothpaste	Active Comparator	Triclosan/Copolymer/fluoride toothpaste	Drug: Triclosan/Copolymer/fluoride toothpaste
Fluoride toothpaste	Placebo Comparator	sodium monofluorophosphate toothpaste	Drug: Sodium monofluorophosphate toothpaste

Name	Type	Description	Arm Group Labels	Other Names
Triclosan/Copolymer/fluoride toothpaste	Drug	Twice daily usage	Total Toothpaste

Outcomes Module

Primary Outcomes

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.

Secondary Outcomes

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.

Eligibility Module

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
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.

Name	Affiliation	Role
Sara G Grossi, DDS		Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
East Carolina University, Brody School of Medicine		Greenville	North Carolina	27834	United States

ID	Title	Description
FG000	Total Toothpaste	Triclosan/Copolymer/fluoride toothpaste
FG001	Fluoride Toothpaste	Sodium monofluorophosphate toothpaste

Baseline Characteristics Module

ID	Title	Description
BG000	Total Toothpaste	Triclosan/Copolymer/fluoride toothpaste
BG001	Fluoride Toothpaste	sodium monofluorophosphate toothpaste

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Posted

Mean

Standard Deviation

units on a scale

29 days

ID	Title	Description
OG000	Total Toothpaste	Triclosan/Copolymer/fluoride toothpaste
OG001	Fluoride Toothpaste	sodium monofluorophosphate toothpaste

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Total Toothpaste	Triclosan/Copolymer/fluoride toothpaste

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Teeth Sensitive to cold	General disorders		Non-systematic Assessment	2 subjects reported tooth sensitivity to cold.

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases

ID	Term
D010647	Phenyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D010636	Phenols
D001555