The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000817044
Ethics application status
Approved
Date submitted
28/09/2010
Date registered
30/09/2010
Date last updated
17/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Associations between periodontal disease and cardiovascular surrogate endpoints in an adult Indigenous population
Scientific title
Associations between periodontal disease and cardiovascular surrogate endpoints following periodontal treatment in an adult Indigenous population with moderate/severe periodontal disease
Secondary ID [1] 252782 0
n/a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular surrogate endpoints 252147 0
periodontal disease 258284 0
Condition category
Condition code
Oral and Gastrointestinal 252350 252350 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cardiovascular 258492 258492 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The periodontal intervention involves periodontal therapy ie scaling and root planing of a participant's teeth and gums. It occurs at baseline and takes around half an hour to an hour. A registered dental hygienest provides the care.
Intervention code [1] 241519 0
Treatment: Other
Intervention code [2] 257300 0
Prevention
Comparator / control treatment
The usual course of care, which in this case is no care. Periodontal services are not provided in the general course of care remit of publicly funded dental services who provide dental care to Aboriginal populations.
Control group
Active

Outcomes
Primary outcome [1] 253227 0
Carotid Intima-Media Thickness (CIMT). Measured using carotid ultrasound
Timepoint [1] 253227 0
3- and 12- months following periodontal intervention
Primary outcome [2] 253228 0
Pulse Wave Velocity (PWV)...measured using echocardiogram (ECG)
Timepoint [2] 253228 0
3- and 12- months following periodontal intervention
Secondary outcome [1] 262175 0
C-Reactive Protein (CRP), measured by plasma assays Interleukin-6 (IL-6), measured by plasma assays
asymmetrical dimethylarginine (ADMA), measured by plasma assays
plasma glucose, measured by plasma assays
high-/low-density and total cholesterol, measured by plasma assays
glucosylated hemoglobin (HbA1c), measured by plasma assays
blood pressure, measured by automatic sphygmomanometer
body mass index, measured by height and weight
waist-hip ratio, measured directly
Timepoint [1] 262175 0
3- and 12- months following periodontal intervention

Eligibility
Key inclusion criteria
Indigenous persons aged 25+ years that have lived in their current location for 2+ years, and who plan to live at their current location for the next 2 years, with moderate/severe periodontal disease
Minimum age
25 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with rheumatic heart disease history or other cardiac conditions requiring antibiotic prophylaxis for prevention of subacute bacterial endocarditis, or with obvious endodontic lesions or other sources of oral infection.

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)
Participants enrolled through community consultation and screening procedures.

Random allocation to intervention or control group occurs through central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer algorithm
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Delayed intervention design; all participants ultimate receive the benefits of the intervention.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
NT

Funding & Sponsors
Funding source category [1] 243993 0
Government body
Name [1] 243993 0
National Health and Medical Research Council
Address [1] 243993 0
GPO Box 1421
Canberra ACT 2601
Country [1] 243993 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
122 Frome St
Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 251345 0
None
Name [1] 251345 0
Address [1] 251345 0
Country [1] 251345 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259790 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 259790 0
Research Branch
Research Ethics and Compliance Unit
University of Adelaide
SA 5005
Ethics committee country [1] 259790 0
Australia
Date submitted for ethics approval [1] 259790 0
Approval date [1] 259790 0
15/12/2009
Ethics approval number [1] 259790 0
H-179-2009

Summary
Brief summary
The relationship between periodontal disease and cardiovascular surrogate endpoints, both of which are high among the Indigenous Australian population, is established. This study seeks to explore the prevalence of cardiovascular surrogate endpoints among this population with periodontal disease, and to determine if implementation of a periodontal intervention leads to improved cardiovascular risk outcomes. There may be benefit in applying this model to other areas of Indigenous health research.
Trial website
n/a
Trial related presentations / publications
Trial publications include:
Kapellas K, Do LG, Bartold PM, Skilton MR, Maple-Brown LJ, O'Dea K, Brown A, Celermajer DS, Slade GD, Jamieson LM. Effects of full-mouth scaling on the periodontal health of indigenous australians: A randomized controlled trial. Journal of Clinical Periodontology. 2013;40:1016-1024

Trial Presentations include:
"Periodontal Outcomes from Single-visit Non-surgical Periodontal Therapy among Indigenous Australians" presented at: International Association of Dental Research 91st General Session, Seattle, Mar 20–23, 2013
Public notes

Contacts
Principal investigator
Name 30479 0
A/Prof Lisa M Jamieson
Address 30479 0
Australian Research Centre for Population Oral Health University of Adelaide 122 Frome St South Australia 5005
Country 30479 0
Australia
Phone 30479 0
+61883134611
Fax 30479 0
Email 30479 0
lisa.jamieson@adelaide.edu.au
Contact person for public queries
Name 13726 0
A/Prof Lisa Jamieson
Address 13726 0
Australian Research Centre for Population Oral Health
University of Adelaide
122 Frome St
South Australia 5005
Country 13726 0
Australia
Phone 13726 0
+61 8 8313 4611
Fax 13726 0
+61 8 8313 4858
Email 13726 0
lisa.jamieson@adelaide.edu.au
Contact person for scientific queries
Name 4654 0
A/Prof Lisa Jamieson
Address 4654 0
Australian Research Centre for Population Oral Health
University of Adelaide
122 Frome St
South Australia 5005
Country 4654 0
Australia
Phone 4654 0
+61 8 8313 4611
Fax 4654 0
+61 8 8313 4858
Email 4654 0
lisa.jamieson@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary