Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000340639
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
9/09/2005
Date last updated
9/09/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
RMI Adult Oral Health Programme
Scientific title
The effect of periodontal treatment and the use of a triclosan containing toothpaste on glycaemic control in diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes and Periodontal Disease 433 0
Condition category
Condition code
Metabolic and Endocrine 504 504 0 0
Diabetes
Oral and Gastrointestinal 505 505 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Instruction in oral care, standard non- surgical periodontal treatment + allocation to triclosan/fluoride or fluoride toothpaste.
Intervention code [1] 373 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 575 0
Changes in HbA1c from baseline to 6 and 12 months
Timepoint [1] 575 0
At baseline, 6 and 12 months
Primary outcome [2] 576 0
Changes in C-peptide from baseline to 6 and 12 months
Timepoint [2] 576 0
At baseline, 6 and 12 months
Secondary outcome [1] 1229 0
Changes in periodontal parameters
Timepoint [1] 1229 0
From baseline to 6 and 12 months.
Secondary outcome [2] 1230 0
Inflammatory markers
Timepoint [2] 1230 0
From baseline to 6 and 12 months.
Secondary outcome [3] 1231 0
Plaque bacteria
Timepoint [3] 1231 0
From baseline to 6 and 12 months.

Eligibility
Key inclusion criteria
Able to give informed consent, random glucose >200mg/dL, at least 16 teeth, chronic periodontitis.
Minimum age
35 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, requirement for antibiotic cover for dental treatment, anticoagulant therapy, 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)
Concealed to examining dentist in sealed envelopes until interventions are assigned
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random allocation using SPSSv13 - no stratification or blocking
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 567 0
Commercial sector/Industry
Name [1] 567 0
Colgate Palmolive Co USA
Country [1] 567 0
United States of America
Primary sponsor type
University
Name
Oral Care Research Programme, The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 459 0
Government body
Name [1] 459 0
Ministry of Health, Republic of Marshall Islands
Address [1] 459 0
Country [1] 459 0
Marshall Islands

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1589 0
The University of Queensland Medical Research Ethics Committee and
Ethics committee address [1] 1589 0
Ethics committee country [1] 1589 0
Australia
Date submitted for ethics approval [1] 1589 0
Approval date [1] 1589 0
Ethics approval number [1] 1589 0
Ethics committee name [2] 1590 0
Institutional Review Committee of the Ministry of Health
Ethics committee address [2] 1590 0
Ethics committee country [2] 1590 0
Marshall Islands
Date submitted for ethics approval [2] 1590 0
Approval date [2] 1590 0
Ethics approval number [2] 1590 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36316 0
Address 36316 0
Country 36316 0
Phone 36316 0
Fax 36316 0
Email 36316 0
Contact person for public queries
Name 9562 0
Dr Ohnmar Tut
Address 9562 0
Dental Division
Ministry of Health
PO Box 16
Majuro MH 96960
Country 9562 0
Marshall Islands
Phone 9562 0
+692 6253355 (Ext. 2101/2102)
Fax 9562 0
+692 6254372/3432
Email 9562 0
ddsmohe@ntamar.net
Contact person for scientific queries
Name 490 0
Dr Mary Cullinan
Address 490 0
Oral Care Research Programme
Oral Biology and Pathology
University of Queensland
Brisbane QLD 4072
Country 490 0
Australia
Phone 490 0
+61 7 33651905
Fax 490 0
+61 7 33651109
Email 490 0
m.cullinan@uq.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.