The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
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|ClinicalTrials.gov Identifier: NCT00763256|
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : April 2, 2012
Last Update Posted : July 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Periodontal Disease||Drug: Triclosan, Fluoride Drug: Fluoride||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
|Active Comparator: A||
Drug: Triclosan, Fluoride
subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.
Other Name: triclosan/fluoride/copolymer toothpaste
|Placebo Comparator: B||
subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.
Other Name: current marketed fluoride only toothpaste
- HbA1c Levels in Blood [ Time Frame: 12 months ]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 ]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 ]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 ]
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 ]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 learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763256
|Logan Hospital Oral Health Clinic|
|Principal Investigator:||Gregory Seymour, BDS||University of Otago|