Trial Review

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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
ACTRN12612000712808
Ethics application status
Approved
Date submitted
3/07/2012
Date registered
3/07/2012
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
"Smiles not Tears" an Aboriginal Health Worker Led Dental Health Education Program.
Scientific title
A Phase II Clinical Trial of a Dental Health Education Program Delivered by Aboriginal Health Workers to Prevent Early Childhood Caries
Secondary ID [1] 280768 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Smiles not Tears
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Childhood Caries 286826 0
Condition category
Condition code
Oral and Gastrointestinal 287135 287135 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 287138 287138 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Program will deliver advice from Aboriginal Health Workers on Toothbrushing,diet and use of fluoride toothpaste to Aboriginal families over a two year period.The Program will consist of 6 home visits. The time per visit will be approximately 45 mins,but there will be built in flexibility for the AHWs.

Visit 1 when the child is 6 months old will focus on avoiding the night time comforter bottle and not adding sugar to the liquids used. Visit 2 at 9 months, reinforce bottle advice,toothpaste and tooth brushes supplied for all the family. Visit 3 at 12 months. Screen for early caries, toothpaste and brushes provided,advice on toothpaste storeage and diet advice.Visit 4 at18 months Check child is not using night time bottle,provide more brushes and toothpaste,advice on safe storeage of toothpaste,safe snacking advice,and screen for early dental caries. Visit 5 at 24 months, simple diet advice,check toothbrushing behavior,toothpaste ,toothpaste given,and screen for early dental caries. Visit 6, final part of intervention, full dental examination by dental examiner,further supplies of toothpaste and brushes, plus research interviews with carers and AHWs.
Intervention code [1] 285195 0
Prevention
Intervention code [2] 285197 0
Lifestyle
Intervention code [3] 285198 0
Early detection / Screening
Comparator / control treatment
A historical control group of children aged 3-4 years will be examined in preschools in the AMSs where the program is being implemented during 2012 and their dental caries rates recorded. The oral health of the active group will be compared with the historical controls at the end of the trial.
Control group
Historical

Outcomes
Primary outcome [1] 287450 0
Clinical data in terms of decayed ,missing and filled primary teeth(dmft scores) will be recorded when the child participants are 30months old and compared with the historical controls
Timepoint [1] 287450 0
The study recruits children aged 6 months and the final clinical data is recorded when the child is 30 months old.
Primary outcome [2] 287451 0
Changes in the oral health knowledge of primary care givers over time, by recording knowledge after each visit,utilising stadardised quetionnaires.
Timepoint [2] 287451 0
Base line knowledge recorded at baseline and at six month intervals over the two year period of the program.
Secondary outcome [1] 298177 0
Early referral for dental care, if screening by Aboriginal Health Workers notes a problem.
Timepoint [1] 298177 0
The referral of children will be recorded every 6 months over the two year period of the study
Secondary outcome [2] 298178 0
Acceptability of the Program recorded by A/Prof Fiona Blinkhorn interviewing parents and Aboriginal Health Workers.
Timepoint [2] 298178 0
Interviews at the end of the two year Program

Eligibility
Key inclusion criteria
Aboriginal Child
Minimum age
5 Months
Maximum age
7 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
none

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Aboriginal Health workers will recruit families into the trial who have a child aged5-7 months.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There is no randomisation, the AHWs will recruit up to ten families
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5489 0
2478
Recruitment postcode(s) [2] 5490 0
2800

Funding & Sponsors
Funding source category [1] 285554 0
Government body
Name [1] 285554 0
National Health and Medical Research Council
Country [1] 285554 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
1 Mons Road,
Westmead
NSW 2145
Country
Australia
Secondary sponsor category [1] 284394 0
University
Name [1] 284394 0
University of Newcastle
Address [1] 284394 0
10 Chittaway Road, Ourimbah NSW,2258
Country [1] 284394 0
Australia
Other collaborator category [1] 276898 0
Individual
Name [1] 276898 0
Professor Ngiare Brown
Address [1] 276898 0
University of Woolongong New South Wales 2522
Country [1] 276898 0
Australia
Other collaborator category [2] 276899 0
Individual
Name [2] 276899 0
A/Profesor Fiona Blinkhorn
Address [2] 276899 0
Univesity of Newcastle, Faculty of Health Sciences, Ourimbah Campus, NSW 2522
Country [2] 276899 0
Australia
Other collaborator category [3] 276900 0
Individual
Name [3] 276900 0
Dr Andrew Martin
Address [3] 276900 0
NHMRC Clinical Trials Unit, 5/88 Mallet Street,University of Sydney, Camperdown, NSW 2050.
Country [3] 276900 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287568 0
AH&MRC Ethics Committee
Ethics committee address [1] 287568 0
Ethics committee country [1] 287568 0
Australia
Date submitted for ethics approval [1] 287568 0
Approval date [1] 287568 0
25/11/2009
Ethics approval number [1] 287568 0
HREC09/RPAH/85

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

Contacts
Principal investigator
Name 34386 0
Address 34386 0
Country 34386 0
Phone 34386 0
Fax 34386 0
Email 34386 0
Contact person for public queries
Name 17633 0
Prof Anthony Blinkhorn
Address 17633 0
1 Mons Road, Westmead, NSW 2145
Country 17633 0
Australia
Phone 17633 0
61 2 8821 4361
Fax 17633 0
61 2 8821 4366
Email 17633 0
[email protected]
Contact person for scientific queries
Name 8561 0
Prof Anthony Blinkhorn
Address 8561 0
1 Mons Road, Westmead, NSW 2145
Country 8561 0
Australia
Phone 8561 0
61 2 8821 4361
Fax 8561 0
61 2 8821 4366
Email 8561 0
[email protected]

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.