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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Scientific title
The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics
Secondary ID [1] 0 0
2004000841/2004/201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontal Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
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).
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
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).
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
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)
Timepoint [4] 0 0
12 months
Primary outcome [5] 0 0
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.
Timepoint [5] 0 0
12 months

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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Logan Hospital Oral Health Clinic - Queensland
Recruitment postcode(s) [1] 0 0
- Queensland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Colgate Palmolive
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To test effectiveness of dentifrice in maintaining periodontal health.
Trial website
https://clinicaltrials.gov/show/NCT00763256
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory Seymour, BDS
Address 0 0
University of Otago
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications