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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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

Study type
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
Intervention code [2] 285197 0
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

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

Key inclusion criteria
Aboriginal Child
Minimum age
5 Months
Maximum age
7 Months
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

Study design
Purpose of the study
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 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5489 0
Recruitment postcode(s) [2] 5490 0

Funding & Sponsors
Funding source category [1] 285554 0
Government body
Name [1] 285554 0
National Health and Medical Research Council
Address [1] 285554 0
GPO BOX 1421,
ACT 2601
Country [1] 285554 0
Primary sponsor type
University of Sydney
1 Mons Road,
NSW 2145
Secondary sponsor category [1] 284394 0
Name [1] 284394 0
University of Newcastle
Address [1] 284394 0
10 Chittaway Road,
Country [1] 284394 0
Other collaborator category [1] 276898 0
Name [1] 276898 0
Professor Ngiare Brown
Address [1] 276898 0
University of Woolongong
New South Wales
Country [1] 276898 0
Other collaborator category [2] 276899 0
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
Other collaborator category [3] 276900 0
Name [3] 276900 0
Dr Andrew Martin
Address [3] 276900 0
NHMRC Clinical Trials Unit,
5/88 Mallet Street,University of Sydney,
NSW 2050.
Country [3] 276900 0

Ethics approval
Ethics application status
Ethics committee name [1] 287568 0
AH&MRC Ethics Committee
Ethics committee address [1] 287568 0
Level 3,66 Wentworth Avenue,
Surrey Hills,
NSW 2010
Ethics committee country [1] 287568 0
Date submitted for ethics approval [1] 287568 0
Approval date [1] 287568 0
Ethics approval number [1] 287568 0

Brief summary
Early dental decay causes much pain and suffering to very young Aboriginal children. Unfortunately dental services for many of these communities are very limited, so it is vital to utilise local health care workers to give parents advice on how to prevent dental decay. Simple dietary changes,especially night time bottle use and ealy introduction of fluoride toothpaste can greatly reduce dental decay. We wish to recruit Aboriginal Health Workers to take on this educaton program as they are well known in their communities and have an existing committment to health promotion. In addition we will be teaching them how to screen for ealy signs of decay, so children with dental problems can be fast tracked for the appropriate care. Our pilot work has led to the development of a culturally acceptable program which the AHWs feel is practical and sustainable. This trial seeks to determine whether the program will actually reduce the prevalence of dental decay in young Aboriginal children and is acceptable to parents and the AHWs.. If successful Aboriginal Medical Services will have evidence based information on which to base their dental preventive programs.
Trial website
Trial related presentations / publications
Public notes

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,
NSW 2145
Country 17633 0
Phone 17633 0
61 2 8821 4361
Fax 17633 0
61 2 8821 4366
Email 17633 0
Contact person for scientific queries
Name 8561 0
Prof Anthony Blinkhorn
Address 8561 0
1 Mons Road,
NSW 2145
Country 8561 0
Phone 8561 0
61 2 8821 4361
Fax 8561 0
61 2 8821 4366
Email 8561 0

No information has been provided regarding IPD availability
Summary results
No Results