Effectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Periodontal Treatment and the Use of a Triclosan/Copolymer/Fluoride Toothpaste on Glycaemic Control in Diabetics.

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: Triclosan/copolymer/fluoride
* Drug: Fluoride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total toothpaste<br>Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. | Drug: Triclosan/copolymer/fluoride<br>* 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.<br>* Other names: Total toothpaste;|
| Placebo Comparator: Fluoride mouthrinse<br>Swish whole mouth 2x/day for 12 months with fluoride mouthrinse. | Drug: Fluoride<br>* 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.<br>* Other names: Fluorigard oral rinse;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |