The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics

Study Overview
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Brief Summary
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To test effectiveness of dentifrice in maintaining periodontal health.

Official Title
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The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics

Conditions
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Periodontal Disease

Intervention / Treatment
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* Drug: Triclosan, Fluoride
* Drug: Fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Poor glycaemic control as evidenced by an HbA1c of >6.0% for the past 12 months Aged 18 to 75 years Able to give informed consent Minimum of 12 teeth Chronic periodontitis as indicated by periodontal probing depths >5mm on at least 6 teeth Exclusion Criteria: Pregnancy Gross dental caries Prosthetic heart valves, a history of infective endocarditis or any other condition requiring antibiotic cover for dental treatment (rheumatic fever, mitral valve prolapse with regurgitation) Anticoagulant therapy (excluding asprin)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Triclosan, Fluoride<br>* subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.<br>* Other names: triclosan/fluoride/copolymer toothpaste;|
| Placebo Comparator: B<br> | Drug: Fluoride<br>* subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.<br>* Other names: current marketed fluoride only toothpaste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 12 months |