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
ACTRN12616001537448
Ethics application status
Approved
Date submitted
28/10/2016
Date registered
8/11/2016
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Date results information initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Management of dental decay in young Aboriginal children
Scientific title
Minimally invasive approach to manage early childhood caries in Aboriginal preschoolers
Secondary ID [1] 290409 0
NHMRC Project APP1121982
Universal Trial Number (UTN)
U1111-1189-1708
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental decay 300748 0
Condition category
Condition code
Oral and Gastrointestinal 300581 300581 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 300582 300582 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aboriginal communities in the Kimberley region of Western Australia will be invited to participate. Communities will be randomised to intervention or control. Children in the intervention communities will be offered care in which minimally invasive approach based on the Atraumatic Restorative Treatment approach, including the Hall crown technique, will be used to provide the necessary care. Treatment will be provided by dental therapists with at least 5-years post-graduate experience to deliver ART and the Hall crowns . The ART approach will use hand instruments to remove dental decay, without the use of local analgesia, while placement of the Hall stainless steel crown will be undertaken without any tooth preparation or use of local analgesia. Any remaining at risk tooth surfaces will also be provided with a glass-ionomer fissure sealant. Treatment will be provided using portable dental equipment within community settings. The procedures are expected to take 30 minutes on each occasions while the number of occasions of treatment will vary, depending on the level of need for care. Children will also be provided with fluoride varnish applications and oral health promotion intervention by the dental therapist to the child and their carers to reduce the incidence of dental decay. The fluoride varnish, 0.25 ml of Duraphat varnish (22,600 ppm fluoride) will be applied to at risk surfaces at each checkup visit. The oral health promotion will also be delivered by dental therapists, face-to-face at recall check-ups and in group setting within the community, using the Aboriginal-specific resource kit for early childhood caries developed by the Dental Health Services (DHS), comprising flashcards on specific topics with relevant information. Face-to face intervention will take between 5-10 minutes while group sessions will be undertaken at the baseline, six-month and 12-month visit to the communities and will take approximately 45 minutes. Interested significant community members will also be provided with training and continuing support by dental therapists to undertake community oral health promotion activities, including “yarning” sessions with parents of newborn children, again using the DHS resource kit, based on anticipatory guidance and motivational interviewing approaches. The half-day training will involve a presentation outlining the causes of early childhood dental decay and role-play in the use of traditional "yarning" as a process of delivering information and motivating mothers/carers to change behaviour. The children will have six-monthly dental check-ups for 12 months, a total of 3 checkups, one at baseline, then at 6 months and then at 12 months; and further treatment as required will be provided at the appointments. Types of treatments provided and attendance for care will be reviewed from case-notes of the participants.
Intervention code [1] 296241 0
Treatment: Surgery
Intervention code [2] 296242 0
Prevention
Intervention code [3] 296243 0
Behaviour
Comparator / control treatment
The comparator will be children in the communities allocated to the standard care arm of the trial, which comprise screening of children by health care workers and application of fluoride varnish to prevent dental decay. Children found to be in need of restorative care will be provided with appropriate referral for care to be delivered by local oral health care practitioners, as per the prevailing standard care pathway. The children will be reviewed for the study evaluations after 12 months, after which time the communities will be offered the option of participating in the intervention treatment as delayed intervention.
Control group
Active

Outcomes
Primary outcome [1] 300000 0
Proportion of children with dental decay successfully managed in each arm of the trial by reviewing case notes to determine the number of children referred for specialist paediatric dental care under general anaesthesia.
Timepoint [1] 300000 0
12 months post-treatment
Primary outcome [2] 300001 0
Changes in child oral health related quality of life using the Early Childhood Oral Health Impact Scale.
Timepoint [2] 300001 0
Change from baseline and 12 months post-treatment.
Primary outcome [3] 300002 0
Dental decay increment using the International Caries Detection and Assessment System (ICDAS) by examiners masked to group allocation status.
Timepoint [3] 300002 0
Change from baseline and 12 months post-treatment.
Secondary outcome [1] 328783 0
Evaluate the child dental anxiety by using the Modified Child Dental Anxiety Scale –FACES (MCDAS) where appropriate.
Timepoint [1] 328783 0
Change from baseline and 12 months post-treatment.
Secondary outcome [2] 328784 0
Incidence of dental infections from parent/carer reports and clinical case notes.
Timepoint [2] 328784 0
12 months post-treatment.

Eligibility
Key inclusion criteria
Children younger than 72 months of age with early childhood dental decay within an Aboriginal community.
Minimum age
No limit
Maximum age
72 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with medical or developmental conditions requiring specialist treatment under general anaesthesia. Children with acute dental infections requiring urgent dental care.

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)
The study is a cluster randomised trial where participating communities will be randomly allocated to intervention or control group. Group assignment will be undertaken by the central study coordinator not involved in treatment of the children.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation will be determined through a computer-generated random list.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The study will use a delayed intervention whereby the control group will be offered the intervention after a 12-month period. Because of the lack of access to dental care by children in Aboriginal communities, and while only children younger than 72 months of age will be evaluated within the study, all children within the community will be offered care, depending on resources availability. Masking of treatment clinicians nor study participants to the intervention will not be possible. The 12-month post-treatment evaluation will be undertaken by masked calibrated examiners.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
sample size — estimate based on recently completed study in WA, which reported a nine-fold difference in the proportion of children referred for specialist paediatric dentist care (5% vs 49%) using ART. A conservative difference in effect size of 2.5 was assumed to estimate the sample size (10% vs 25%). The intra cluster correlation was estimated from the caries experience of Aboriginal children participating in another cluster randomized trial (0.05). Using these parameters, with 15 clusters available in each arm of the trial, the estimated sample size required, at 80% power and alpha at 0.05, was 165 in each arm of the trial with 11 children per cluster. Allowing for loss to follow-up of 25%, the estimated sample size is 220 per arm of the study or 15 children per cluster.
Statistical Analysis — Data will be analysed on an intention-to-treat, and per protocol basis. Descriptive statistics will be presented and baseline variables will be compared between groups to test for fairness with respect to the randomisation. Test of proportions and logistic regression to control for potentially confounding factors will be used to assess proportion of children referred for specialist care. Changes in health utility and COHRQoL will be tested using paired (within group) and unpaired (between groups) and parametric and non-parametric tests as appropriate, and multivariate analysis using linear regression for continuous variables and Poisson regression for count variables to control for possible inter-group imbalances. Responsiveness of the COHRQoL scale will be determined by calculation of effect sizes for the scale overall and specific domains. Statistical significance will be set at alpha 0.05. All analyses will take account of the cluster design and will incorporate multi-level analyses where indicated. Multiple imputation of missing data will be further undertaken to evaluate its impact on the primary and secondary outcomes.

Recruitment
Recruitment status
Active, not 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)
WA

Funding & Sponsors
Funding source category [1] 294819 0
Government body
Name [1] 294819 0
National Health and Medical Research Council
Address [1] 294819 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 294819 0
Australia
Primary sponsor type
Government body
Name
Dental Health Services, Western Australia
Address
Dental Health Services
Locked Bag 15
Bentley Delivery Centre 6983
Perth, Western Australia
Country
Australia
Secondary sponsor category [1] 293664 0
None
Name [1] 293664 0
Address [1] 293664 0
Country [1] 293664 0
Other collaborator category [1] 279283 0
University
Name [1] 279283 0
University of Adelaide
Address [1] 279283 0
Australian Research Centre for Population Oral Health
The University of Adelaide, AUSTRALIA 5005
Country [1] 279283 0
Australia
Other collaborator category [2] 279284 0
University
Name [2] 279284 0
Deakin University
Address [2] 279284 0
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country [2] 279284 0
Australia
Other collaborator category [3] 279285 0
University
Name [3] 279285 0
Griffith University
Address [3] 279285 0
Griffith University (Nathan campus - N78 1.11)
170 Kessels Road
Nathan Qld 4111, Australia
Country [3] 279285 0
Australia
Other collaborator category [4] 279286 0
Other
Name [4] 279286 0
Kimberley Aboriginal Medical Services
Address [4] 279286 0
12 Napier Terrace
PO Box 1377,
Broome
Western Australia, 6725
Country [4] 279286 0
Australia
Other collaborator category [5] 279287 0
University
Name [5] 279287 0
University of Western Australia
Address [5] 279287 0
The University of Western Australia
35 Stirling Highway
Perth WA 6009
Australia
Country [5] 279287 0
Australia
Other collaborator category [6] 279288 0
University
Name [6] 279288 0
Flinders University
Address [6] 279288 0
GPO Box 2100
Adelaide 5001, South Australia
Country [6] 279288 0
Australia
Other collaborator category [7] 279289 0
University
Name [7] 279289 0
Murdoch University
Address [7] 279289 0
90 South Street, Murdoch
Western Australia 6150
Country [7] 279289 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296210 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [1] 296210 0
450 Beaufort Street, Highgate
Perth WA 6003
Ethics committee country [1] 296210 0
Australia
Date submitted for ethics approval [1] 296210 0
30/11/2016
Approval date [1] 296210 0
08/08/2017
Ethics approval number [1] 296210 0
WAAHEC HREC Project Reference: 790
Ethics committee name [2] 298422 0
University of Adelaide HREC
Ethics committee address [2] 298422 0
Level 4, Rundle Mall Plaza
50 Rundle Mall
Adelaide, SA, 5000
Ethics committee country [2] 298422 0
Australia
Date submitted for ethics approval [2] 298422 0
24/11/2016
Approval date [2] 298422 0
27/02/2017
Ethics approval number [2] 298422 0
H-2017-015
Ethics committee name [3] 298423 0
Western Australia Country Health Service HREC
Ethics committee address [3] 298423 0
WA Country Health Service, HREC
189 Wellington Street
Perth, WA, 6000
Ethics committee country [3] 298423 0
Australia
Date submitted for ethics approval [3] 298423 0
19/01/2017
Approval date [3] 298423 0
09/08/2017
Ethics approval number [3] 298423 0

Summary
Brief summary
The principal aim of the proposed study is to develop, implement and evaluate a minimally invasive model of care to deliver effective primary dental services, including treatment and preventive services, to Aboriginal pre-school children. This will be compared with standard care for cost and benefits in terms of improved dental health, quality of life and reduced childhood dental anxiety.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1972 1972 0 0
Attachments [3] 1974 1974 0 0

Contacts
Principal investigator
Name 69998 0
Dr peter arrow
Address 69998 0
WA Dental Health Services
Locked Bag 15
Bentley Delivery Centre 6983
Perth, Western Australia
Country 69998 0
Australia
Phone 69998 0
+61 8 93130 600
Fax 69998 0
+61 8 9313 1302
Email 69998 0
parrow@ozemail.com.au
Contact person for public queries
Name 69999 0
Dr peter arrow
Address 69999 0
WA Dental Health Services
Locked Bag 15
Bentley Delivery Centre 6983
Perth, Western Australia
Country 69999 0
Australia
Phone 69999 0
+61 8 93130 600
Fax 69999 0
+61 8 9313 1302
Email 69999 0
parrow@ozemail.com.au
Contact person for scientific queries
Name 70000 0
Dr peter arrow
Address 70000 0
WA Dental Health Services
Locked Bag 15
Bentley Delivery Centre 6983
Perth, Western Australia
Country 70000 0
Australia
Phone 70000 0
+61 8 93130 600
Fax 70000 0
+61 8 9313 1302
Email 70000 0
parrow@ozemail.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
protect identity of participating communities.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary