Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To test effectiveness of dentifrice in maintaining periodontal health.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triclosan, Fluoride | Drug | subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Levels in Blood | Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). | 12 months |
| High Sensitivity CRP (C-Reactive Protein) | CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). | 12 months |
| C-Peptide | C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). | 12 months |
| Gingivitis Score (GI) | Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | 12 months |
| P. Gingivalis | Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gregory Seymour, BDS | University of Otago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Logan Hospital Oral Health Clinic | Queensland | Australia |
All subjects passed a medical exam and met the inclusion/exclusion criteria.
all subjects were recruited at the clinical site by the PI.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator | triclosan/fluoride/copolymer toothpaste |
| FG001 | B - Placebo Comparator | fluoride only toothpaste |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator | triclosan/fluoride/copolymer toothpaste |
| BG001 | B - Placebo Comparator | fluoride only toothpaste |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | HbA1c Levels in Blood | Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). | Posted | Mean | Standard Deviation | Percentage | 12 months |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Comparator | triclosan/fluoride/copolymer toothpaste |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William DeVizio, DMD | Colgate Palmolive Co. | 732-878-7901 | william_devizio@colpal.com |
Not provided
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014260 | Triclosan |
| D005459 | Fluorides |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluoride | Drug | subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period. |
|
|
| 12 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | High Sensitivity CRP (C-Reactive Protein) | CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). | Posted | Mean | Standard Deviation | mg/L | 12 months |
|
|
|
|
| Primary | C-Peptide | C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). | Posted | Mean | Standard Deviation | nmol/L | 12 months |
|
|
|
|
| Primary | Gingivitis Score (GI) | Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) | Posted | Mean | Standard Deviation | Units on a scale | 12 months |
|
|
|
|
| Primary | P. Gingivalis | Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation. | Posted | Median | Inter-Quartile Range | Pg/ng DNA | 12 months |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | B - Placebo Comparator | fluoride only toothpaste | 0 | 18 | 0 | 18 |
Not provided
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |