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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00762762




Registration number
NCT00762762
Ethics application status
Date submitted
26/09/2008
Date registered
30/09/2008
Date last updated
26/04/2012

Titles & IDs
Public title
Investigate Plaque and Gingival Index
Scientific title
Investigate Plaque and Gingival Index
Secondary ID [1] 0 0
2004000685
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontitis 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
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Triclosan and fluoride
Treatment: Drugs - Fluoride

Active Comparator: A -

Placebo Comparator: B -


Treatment: Drugs: Triclosan and fluoride
Brush twice daily

Treatment: Drugs: Fluoride
swished twice daily

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

Outcomes
Primary outcome [1] 0 0
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.
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.
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
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
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 picagrams)
Timepoint [4] 0 0
12 months
Primary outcome [5] 0 0
TNF-a (Tumor Necrosis Factor - Alpha) - Blood drawn from subjects to determine the level of TNF-a (Tumor necrosis factor - alpha). TNF-a is a pleiotropic inflammatory cytokine involved in systemic inflammation.
Timepoint [5] 0 0
12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any condition requiring antibiotic cover for dental treatment

- Other serious illness

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


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
Republic of Marshall Islands - 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
Clinical research study to determine the anti-plaque efficacy of commerical dentifrices.
Trial website
https://clinicaltrials.gov/show/NCT00762762
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory Seymour, BDS, PhD
Address 0 0
Otago University
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