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Clinical research study to determine the effectiveness of a triclosan/copolymer/fluoride toothpaste in maintaining periodontal health and therefore glycaemic control in a type 2 diabetic population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total toothpaste | Active Comparator | Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. |
|
| Fluoride mouthrinse | Placebo Comparator | Swish whole mouth 2x/day for 12 months with fluoride mouthrinse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triclosan/copolymer/fluoride | Drug | Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Levels in Blood | Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood. | 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. | 12 months |
| C-Peptide | C-Peptide levels in blood indicate whether or not a person is producing insulin | 12 months |
| IL-6 (Interleukin - 6) | Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picograms) | 12 months |
| TNF-α (Tumor Necrosis Factor - Alpha) | Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Seymour, BDS, PhD | Otago University | Principal Investigator |
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all subjects pass a medical exam and meet the study inclusion/exclusion criteria.
all subjects were recruited by the PI at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator | triclosan/fluoride/copolymer toothpaste |
| FG001 | Placebo Comparator | Anti-cavity, fluoride oral rinse |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Fourteen (14) participants completed baseline data, but did not return for 1 outcome measurement. Lost to follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator | triclosan/fluoride/copolymer toothpaste |
| BG001 | Placebo Comparator | Anti-cavity, fluoride oral rinse |
| 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 | Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood. | Posted | Mean | Standard Deviation | percentage of HbA1c levels in blood | 12 months |
|
12 months (1 years)
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| 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 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William DeVizio, DMD | Colgate Palmolive Co. | 732-878-7901 | william_devizio@colpal.com |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014260 | Triclosan |
| C546060 | hydrated silica gel-based toothpaste |
| D005459 | Fluorides |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 |
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|
| Fluoride | Drug | Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses. |
|
|
| 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 |
|
Swish whole mouth 2x/day for 12 months with fluoride mouthrinse.
Fluoride: Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
|
|
|
| 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. | Posted | Mean | Standard Deviation | µg/ml | 12 months |
|
|
|
|
| Primary | C-Peptide | C-Peptide levels in blood indicate whether or not a person is producing insulin | Posted | Mean | Standard Deviation | ng/ml | 12 months |
|
|
|
|
| Primary | IL-6 (Interleukin - 6) | Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picograms) | Posted | Mean | Standard Deviation | pg/ml | 12 months |
|
|
|
|
| Primary | TNF-α (Tumor Necrosis Factor - Alpha) | Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation. | Posted | Mean | Standard Deviation | pg/ml | 12 months |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | µg/ml | 12 months |
|
|
|
|
| Primary | HbA1c Levels in Blood | Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood. | Fourteen (14) participants did not report for 1 year clinical appointment. Lost to follow up. | Posted | Mean | Standard Deviation | percentage of HbA1c levels | 12 months |
|
|
|
|
| Primary | C-Peptide | C-Peptide levels in blood indicate whether or not a person is producing insulin | Posted | Mean | Standard Deviation | ng/ml | 12 months |
|
|
|
|
| Primary | IL-6 (Interleukin - 6) | Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picograms) | Posted | Mean | Standard Deviation | pg/ml | 12 months |
|
|
|
|
| Primary | TNF-α (Tumor Necrosis Factor - Alpha) | Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation. | Posted | Mean | Standard Deviation | pg/ml | 12 months |
|
|
|
|
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo Comparator | Anti-cavity, fluoride oral rinse | 0 | 30 | 0 | 30 | 0 | 30 |
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| 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 |