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

Periodontal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763256
• Other study ID #: 2004000841/2004/201
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: July 10, 2015
• Start date: May 2006
• Est. completion date: August 2009

Study information

• Verified date: July 2015
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To test effectiveness of dentifrice in maintaining periodontal health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Drug:
• Triclosan, Fluoride
subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.
• Fluoride
subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.

Locations

Country	Name	City	State
Australia	Logan Hospital Oral Health Clinic	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
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. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).	12 months	No
Primary	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	No
Primary	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	No
Primary	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	No