Periodontitis Clinical Trial
Official title:
The Effect of Periodontal Treatment and the Use of a Triclosan/Copolymer/Fluoride Toothpaste on Glycaemic Control in Diabetics.
NCT number | NCT00762762 |
Other study ID # | 2004000685 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | March 2006 |
Est. completion date | December 2008 |
Verified date | April 2012 |
Source | Colgate Palmolive |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Colgate Palmolive |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 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. | 12 months | |
Primary | C-Peptide | C-Peptide levels in blood indicate whether or not a person is producing insulin | 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) | 12 months | |
Primary | TNF-a (Tumor Necrosis Factor - Alpha) | Blood drawn from subjects to determine the level of TNF-a (Tumor necrosis factor - alpha). TNF-a is a pleiotropic inflammatory cytokine involved in systemic inflammation. | 12 months |
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