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

• HbA1c Levels in Blood [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  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).
• High Sensitivity CRP (C-Reactive Protein) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  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).
• C-Peptide [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  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).
• Gingivitis Score (GI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

  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)

• P. Gingivalis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  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.

To test effectiveness of dentifrice in maintaining periodontal health.

• Drug: Triclosan, Fluoride
  subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.
  Other Name: triclosan/fluoride/copolymer toothpaste
• Drug: Fluoride
  subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.
  Other Name: current marketed fluoride only toothpaste

• Active Comparator: A
  Intervention: Drug: Triclosan, Fluoride
• Placebo Comparator: B
  Intervention: Drug: Fluoride

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)