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

Phase 3

Completed

• Conditions: Periodontal Disease
• Interventions: Drug: Triclosan, Fluoride; Drug: Fluoride

• Registration Number: NCT00763256
• Lead Sponsor: Colgate Palmolive

Brief Summary

To test effectiveness of dentifrice in maintaining periodontal health.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2012-03-05
• Results First Submitted QC: 2012-03-05
• Results First Posted: 2012-04-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-10
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Triclosan, Fluoride	-
B	Fluoride	-

Primary Outcome Measures

Name	Time	Method
HbA1c Levels in Blood	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)	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	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)	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	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.

Trial Locations

Locations (1)

Logan Hospital Oral Health Clinic; 🇦🇺 Queensland, Australia