Back to resultsEffectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Triclosan/copolymer/fluoride
Fluoride
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Total toothpaste
Fluoride mouthrinse
Arm Description
Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste.
Swish whole mouth 2x/day for 12 months with fluoride mouthrinse.
Outcomes
Primary Outcome Measures
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.
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.
C-Peptide
C-Peptide levels in blood indicate whether or not a person is producing insulin
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)
TNF-α (Tumor Necrosis Factor - Alpha)
Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00762762
Brief Title
Effectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population
Official Title
The Effect of Periodontal Treatment and the Use of a Triclosan/Copolymer/Fluoride Toothpaste on Glycaemic Control in Diabetics.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2006 (Actual)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Total toothpaste
Arm Type
Active Comparator
Arm Description
Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste.
Arm Title
Fluoride mouthrinse
Arm Type
Placebo Comparator
Arm Description
Swish whole mouth 2x/day for 12 months with fluoride mouthrinse.
Intervention Type
Drug
Intervention Name(s)
Triclosan/copolymer/fluoride
Other Intervention Name(s)
Total toothpaste
Intervention Description
Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
Intervention Type
Drug
Intervention Name(s)
Fluoride
Other Intervention Name(s)
Fluorigard oral rinse
Intervention Description
Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
Primary Outcome Measure Information:
Title
HbA1c Levels in Blood
Description
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.
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.
Time Frame
12 months
Title
C-Peptide
Description
C-Peptide levels in blood indicate whether or not a person is producing insulin
Time Frame
12 months
Title
IL-6 (Interleukin - 6)
Description
Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picograms)
Time Frame
12 months
Title
TNF-α (Tumor Necrosis Factor - Alpha)
Description
Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Seymour, BDS, PhD
Organizational Affiliation
Otago University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population
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