Periodontitis
Conditions
Brief summary
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.
Interventions
DRUGTriclosan/copolymer/fluoride
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.
DRUGFluoride
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.
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Type 2 diabetes with poor glycaemic control as evidenced by random blood glucose of \>200mg/dl. * Minimum of 16 teeth * Chronic periodontitis as indicated by periodontal probing depths \>4mm on at least 6 teeth
Exclusion criteria
* Any condition requiring antibiotic cover for dental treatment * Other serious illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Levels in Blood | 12 months | 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. |
| High Sensitivity CRP (C-Reactive Protein) | 12 months | 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. |
| C-Peptide | 12 months | C-Peptide levels in blood indicate whether or not a person is producing insulin |
| IL-6 (Interleukin - 6) | 12 months | Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picograms) |
| TNF-α (Tumor Necrosis Factor - Alpha) | 12 months | 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. |
Participant flow
Recruitment details
all subjects were recruited by the PI at the clinical site.
Pre-assignment details
all subjects pass a medical exam and meet the study inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Active Comparator triclosan/fluoride/copolymer toothpaste | 30 |
| Placebo Comparator Anti-cavity, fluoride oral rinse | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not return for appointments | 6 | 8 |
Baseline characteristics
| Characteristic | Placebo Comparator | Active Comparator | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Continuous | 48.8 years STANDARD_DEVIATION 8.7 | 50.6 years STANDARD_DEVIATION 7.5 | 49.7 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment Australia | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 17 Participants | 17 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
C-Peptide
C-Peptide levels in blood indicate whether or not a person is producing insulin
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triclosan/Copolymer/Fluoride Toothpaste | C-Peptide | 5.39 ng/ml | Standard Deviation 3.68 |
| Fluoride Mouthrinse | C-Peptide | 4.61 ng/ml | Standard Deviation 2.7 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA
Primary
C-Peptide
C-Peptide levels in blood indicate whether or not a person is producing insulin
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triclosan/Copolymer/Fluoride Toothpaste | C-Peptide | 5.39 ng/ml | Standard Deviation 3.68 |
| Fluoride Mouthrinse | C-Peptide | 4.61 ng/ml | Standard Deviation 0.83 |
Comparison: Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA
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.
Time frame: 12 months
Population: Fourteen (14) participants did not report for 1 year clinical appointment. Lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triclosan/Copolymer/Fluoride Toothpaste | HbA1c Levels in Blood | 11.42 percentage of HbA1c levels | Standard Deviation 1.71 |
| Fluoride Mouthrinse | HbA1c Levels in Blood | 10.81 percentage of HbA1c levels | Standard Deviation 1.76 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triclosan/Copolymer/Fluoride Toothpaste | HbA1c Levels in Blood | 11.42 percentage of HbA1c levels in blood | Standard Deviation 1.71 |
| Fluoride Mouthrinse | HbA1c Levels in Blood | 10.81 percentage of HbA1c levels in blood | Standard Deviation 1.76 |
Comparison: Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triclosan/Copolymer/Fluoride Toothpaste | High Sensitivity CRP (C-Reactive Protein) | 14.94 µg/ml | Standard Deviation 13.62 |
| Fluoride Mouthrinse | High Sensitivity CRP (C-Reactive Protein) | 10.76 µg/ml | Standard Deviation 8.51 |
Comparison: Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triclosan/Copolymer/Fluoride Toothpaste | High Sensitivity CRP (C-Reactive Protein) | 14.94 µg/ml | Standard Deviation 13.62 |
| Fluoride Mouthrinse | High Sensitivity CRP (C-Reactive Protein) | 10.76 µg/ml | Standard Deviation 8.51 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA
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)
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triclosan/Copolymer/Fluoride Toothpaste | IL-6 (Interleukin - 6) | 1.93 pg/ml | Standard Deviation 1.44 |
| Fluoride Mouthrinse | IL-6 (Interleukin - 6) | 2.89 pg/ml | Standard Deviation 3.01 |
Comparison: Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA
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)
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triclosan/Copolymer/Fluoride Toothpaste | IL-6 (Interleukin - 6) | 1.93 pg/ml | Standard Deviation 1.44 |
| Fluoride Mouthrinse | IL-6 (Interleukin - 6) | 2.89 pg/ml | Standard Deviation 3.01 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triclosan/Copolymer/Fluoride Toothpaste | TNF-α (Tumor Necrosis Factor - Alpha) | 4.13 pg/ml | Standard Deviation 4.84 |
| Fluoride Mouthrinse | TNF-α (Tumor Necrosis Factor - Alpha) | 3.50 pg/ml | Standard Deviation 6.41 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Triclosan/Copolymer/Fluoride Toothpaste | TNF-α (Tumor Necrosis Factor - Alpha) | 4.13 pg/ml | Standard Deviation 4.84 |
| Fluoride Mouthrinse | TNF-α (Tumor Necrosis Factor - Alpha) | 3.50 pg/ml | Standard Deviation 6.41 |
Comparison: Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA