Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000607673
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
6/10/2005
Date last updated
6/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oral Health Education Logan Programme
Scientific title
The Effect of a Personalised Oral Health Education Programme on Clinical and Molecular Risk Factors for Oral and General Health in an At Risk Population
Universal Trial Number (UTN)
Trial acronym
OHELP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Health 738 0
Condition category
Condition code
Oral and Gastrointestinal 814 814 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The oral health promotion programme being tested will involve oral health
therapists/hygienists providing an individualised oral health promotion
programme, in addition to standard care, over 1-4 visits. This will include
motivation enhancement, goal setting, problem solving, assertion skills,
followed by monthly reporting on adherence until the 2 year examination.
Intervention code [1] 497 0
Treatment: Other
Comparator / control treatment
The control group will receive routine restorative dental care.
Control group
Active

Outcomes
Primary outcome [1] 1046 0
The level of oral disease.
Timepoint [1] 1046 0
Measured at 12 and 24 months.
Secondary outcome [1] 1942 0
Clinical and molecular risk factors for oral and general health such as diet, oral care, smoking, alcohol consumption, BMI.
Timepoint [1] 1942 0
Measured at 12 and 24 months.
Secondary outcome [2] 1943 0
WHR
Timepoint [2] 1943 0
Measured at 12 and 24 months.
Secondary outcome [3] 1944 0
Cholesterol
Timepoint [3] 1944 0
Measured at 12 and 24 months.
Secondary outcome [4] 1945 0
Triglycerides
Timepoint [4] 1945 0
Measured at 12 and 24 months.
Secondary outcome [5] 1946 0
HbA1c
Timepoint [5] 1946 0
Measured at 12 and 24 months.
Secondary outcome [6] 1947 0
CRP
Timepoint [6] 1947 0
Measured at 12 and 24 months.

Eligibility
Key inclusion criteria
Patients with a minimum of 12 teeth and not requiring antibiotic cover for dental treatment will be included in the study.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Subject allocation is performed by reception staff who allocate the next available study number before participants are seen by research staff. Reception staff are not otherwise involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random allocation with subjects allocated to equal sized 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
3/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 902 0
Government body
Name [1] 902 0
NHMRC
Country [1] 902 0
Australia
Funding source category [2] 903 0
Charities/Societies/Foundations
Name [2] 903 0
Australian Dental Research Fund
Country [2] 903 0
Australia
Primary sponsor type
University
Name
Oral Care Research Programme, The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 762 0
Hospital
Name [1] 762 0
Logan Hospital Oral Health Clinic
Address [1] 762 0
Country [1] 762 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2185 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 2185 0
Ethics committee country [1] 2185 0
Australia
Date submitted for ethics approval [1] 2185 0
Approval date [1] 2185 0
Ethics approval number [1] 2185 0
Ethics committee name [2] 2186 0
The Princess Alexandra Hospital Research Ethics Committee
Ethics committee address [2] 2186 0
Ethics committee country [2] 2186 0
Australia
Date submitted for ethics approval [2] 2186 0
Approval date [2] 2186 0
Ethics approval number [2] 2186 0

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

Contacts
Principal investigator
Name 35974 0
Address 35974 0
Country 35974 0
Phone 35974 0
Fax 35974 0
Email 35974 0
Contact person for public queries
Name 9686 0
Ms Michelle Sankey
Address 9686 0
Oral Health Therapist and Project Officer
Oral Health Clinic
Logan Hospital
Cnr Loganlea and Armstrong Rds
Meadowbank QLD 4131
Country 9686 0
Australia
Phone 9686 0
+61 7 32998900
Fax 9686 0
+61 7 32998745
Email 9686 0
michelle_sankey@health.qld.gov.au
Contact person for scientific queries
Name 614 0
Dr Mary Cullinan
Address 614 0
Oral Care Research Programme
Oral Biology and Pathology
The University of Queensland
Brisbane QLD 4072
Country 614 0
Australia
Phone 614 0
+61 7 33651905
Fax 614 0
+61 7 33651109
Email 614 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
SourceTitleYear of PublicationDOI
EmbaseThe effect of a personalized oral health education program on periodontal health in an at-risk population: A randomized controlled trial.2021https://dx.doi.org/10.3390/ijerph18020846
N.B. These documents automatically identified may not have been verified by the study sponsor.