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Trial registered on ANZCTR


Trial ID
ACTRN12605000260628
Ethics application status
Approved
Date submitted
18/08/2005
Date registered
2/09/2005
Date last updated
2/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of Diabetes after Periodontal Treatment
Scientific title
The effect of periodontal treatment and the use of a triclosan dentifrice on glycaemic control in diabetics
Universal Trial Number (UTN)
Trial acronym
ADAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes and Periodontal Disease 347 0
Condition category
Condition code
Metabolic and Endocrine 402 402 0 0
Diabetes
Oral and Gastrointestinal 403 403 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
Group1- periodontal treatment + random allocation to triclosan or non triclosan toothpaste. The response to treatment will be assessed at 2 weeks, 6 and 12 months.
Intervention code [1] 210 0
Treatment: Other
Comparator / control treatment
Group 2- periodontal treatment after treatment for Group 1 is completed + random allocation to triclosan or non-triclosan toothpaste.
Control group
Active

Outcomes
Primary outcome [1] 461 0
HbA1c
Timepoint [1] 461 0
Measured at 6 and 12 months after treatment
Primary outcome [2] 462 0
C-peptide
Timepoint [2] 462 0
Measured at 6 and 12 months after treatment
Secondary outcome [1] 1002 0
Response to periodontal treatment + any added benefit from triclosan toothpaste
Timepoint [1] 1002 0
Assessed at 2 wks, 6 & 12 months.
Secondary outcome [2] 1003 0
Inflammatory markers, plaque bacteria & antibodies also assessed.
Timepoint [2] 1003 0

Eligibility
Key inclusion criteria
HbA1c>6%, Able to give informed consent, Minimum of 12 teeth, Chronic periodontitis.
Minimum age
35 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, Gross dental caries, Requirement of 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)
Sealed opaque envelopes. As participants are recruited the next envelope in the sequence is opened and the participant asssigned accordingly.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random allocation using SPSS v11. subjects were randomly allocated to equal sized treatment groups and then randomly allocated to toothpaste type within the treatment groups.
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
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)

Funding & Sponsors
Funding source category [1] 452 0
Charities/Societies/Foundations
Name [1] 452 0
Australian Dental Research Fund
Address [1] 452 0
Country [1] 452 0
Australia
Funding source category [2] 453 0
Commercial sector/Industry
Name [2] 453 0
Colgate Palmolive Co
Address [2] 453 0
Country [2] 453 0
United States of America
Primary sponsor type
University
Name
The University of Queensland, Oral Care Research Programme
Address
Country
Australia
Secondary sponsor category [1] 369 0
Hospital
Name [1] 369 0
Oral Health Clinic, Logan Hospital
Address [1] 369 0
Country [1] 369 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1429 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 1429 0
Ethics committee country [1] 1429 0
Australia
Date submitted for ethics approval [1] 1429 0
Approval date [1] 1429 0
Ethics approval number [1] 1429 0
Ethics committee name [2] 1430 0
The Princess Alexandra Hospital Research Ethics Committee
Ethics committee address [2] 1430 0
Ethics committee country [2] 1430 0
Australia
Date submitted for ethics approval [2] 1430 0
Approval date [2] 1430 0
Ethics approval number [2] 1430 0

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

Contacts
Principal investigator
Name 36146 0
Address 36146 0
Country 36146 0
Phone 36146 0
Fax 36146 0
Email 36146 0
Contact person for public queries
Name 9399 0
Michelle Robbins
Address 9399 0
c/- Cardiovascular and Periodontal Study
Team Leader - Diabetes
Logan Hospital
Cnr Loganlea & Armstrong Rds
Meadowbrook QLD 4131
Country 9399 0
Australia
Phone 9399 0
+61 7 32999502
Fax 9399 0
Email 9399 0
m.cullinan@uq.edu.au
Contact person for scientific queries
Name 327 0
Dr Bill Westerman
Address 327 0
Level 1 Clinical Sciences Building
The Prince Charles Hospital
Rode Rd
Chermside QLD 4032
Country 327 0
Australia
Phone 327 0
+61 7 33508300
Fax 327 0
Email 327 0
m.cullinan@uq.edu.au