Back to resultsThe Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
Primary Purpose
Periodontal Disease
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Triclosan, Fluoride
Fluoride
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Disease
Eligibility Criteria
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)
Sites / Locations
- Logan Hospital Oral Health Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
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).
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)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00763256
Brief Title
The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
Official Title
The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To test effectiveness of dentifrice in maintaining periodontal health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Triclosan, Fluoride
Other Intervention Name(s)
triclosan/fluoride/copolymer toothpaste
Intervention Description
subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.
Intervention Type
Drug
Intervention Name(s)
Fluoride
Other Intervention Name(s)
current marketed fluoride only toothpaste
Intervention Description
subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.
Primary Outcome Measure Information:
Title
HbA1c Levels in Blood
Description
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).
Time Frame
12 months
Title
High Sensitivity CRP (C-Reactive Protein)
Description
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).
Time Frame
12 months
Title
C-Peptide
Description
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).
Time Frame
12 months
Title
Gingivitis Score (GI)
Description
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)
Time Frame
12 months
Title
P. Gingivalis
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Seymour, BDS
Organizational Affiliation
University of Otago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Logan Hospital Oral Health Clinic
City
Queensland
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
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