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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Investigate Plaque and Gingival Index
Scientific title
Investigate Plaque and Gingival Index
Secondary ID [1] 0 0
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

Study type
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

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

Key inclusion criteria
- Type 2 diabetes with poor glycaemic control as evidenced by random blood glucose of

- Minimum of 16 teeth

- Chronic periodontitis as indicated by periodontal probing depths >4mm on at least 6
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Any condition requiring antibiotic cover for dental treatment

- Other serious illness

Study design
Purpose of the study
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
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
Colgate Palmolive

Ethics approval
Ethics application status

Brief summary
Clinical research study to determine the anti-plaque efficacy of commerical dentifrices.
Trial website
Trial related presentations / publications
Public notes

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