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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00763256
Registration number
NCT00763256
Ethics application status
Date submitted
26/09/2008
Date registered
30/09/2008
Date last updated
28/07/2015
Titles & IDs
Public title
The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
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Scientific title
The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
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Secondary ID [1]
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2004000841/2004/201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Periodontal Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Infection
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Triclosan, Fluoride
Treatment: Drugs - Fluoride
Active comparator: A -
Placebo comparator: B -
Treatment: Drugs: Triclosan, Fluoride
subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.
Treatment: Drugs: Fluoride
subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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HbA1c Levels in Blood
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Assessment method [1]
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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).
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Timepoint [1]
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12 months
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Primary outcome [2]
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High Sensitivity CRP (C-Reactive Protein)
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Assessment method [2]
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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).
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Timepoint [2]
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12 months
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Primary outcome [3]
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C-Peptide
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Assessment method [3]
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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).
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Timepoint [3]
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12 months
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Primary outcome [4]
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Gingivitis Score (GI)
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Assessment method [4]
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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)
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Timepoint [4]
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12 months
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Primary outcome [5]
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P. Gingivalis
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Assessment method [5]
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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.
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Timepoint [5]
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12 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2009
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Sample size
Target
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Accrual to date
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Final
33
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Logan Hospital Oral Health Clinic - Queensland
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Recruitment postcode(s) [1]
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- Queensland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Colgate Palmolive
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To test effectiveness of dentifrice in maintaining periodontal health.
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Trial website
https://clinicaltrials.gov/study/NCT00763256
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gregory Seymour, BDS
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Address
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University of Otago
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00763256
Download to PDF