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Trial registered on ANZCTR
Registration number
ACTRN12612000474853
Ethics application status
Approved
Date submitted
29/04/2012
Date registered
1/05/2012
Date last updated
1/05/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Dental therapist treatment of early childhood dental decay among preschool children
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Scientific title
Effectiveness of dental therapist treatment of early childhood dental caries among preschool children
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Secondary ID [1]
280418
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
The treatment of early childhood dental caries
286387
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Condition category
Condition code
Oral and Gastrointestinal
286636
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment of early childhood dental caries by school dental therapists using the Atraumatic Restorative Treatment approach (ART) compared with the standard care provided by dentists within public dental services. Children will have teeth requiring restorations treated using hand instruments, without the use of local analgesia and the prepared tooth restored with a glass-ionomer cement. The duration of each treatment session is expected to last approximately 15-20 minutes. Preventive application of fluoride varnish to interproximal areas and areas with white spot lesions will also be undertaken every 6 months. Children will be assessed 12 months after treatment completed
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Intervention code [1]
284773
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Treatment: Other
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Comparator / control treatment
Standard dental treatment provided by dentists within public dental services using standard treatment protocols. Children requiring restorative treatment will have teeth prepared using engine driven instruments and local analgesia, and the prepared cavity restored with the material chosen at clinician's discretion. Preventive therapeutic agents will be provided the discretion of the treating clinician. Children will be evaluated 12 months after treatment.
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Control group
Active
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Outcomes
Primary outcome [1]
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Quality of restorations will be assessed at 12 months following the criteria of Frencken et.al. (1996) by examining each child participant.
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Assessment method [1]
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Timepoint [1]
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Evaluated 12 months after post intervention
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Primary outcome [2]
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Incidence of dental caries will be evaluated after 12 months using the criteria of Drury et.al. (1999)by a clinical examination of each child participant.
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Assessment method [2]
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Timepoint [2]
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Evaluated after 12 months
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Secondary outcome [1]
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Child oral health-related quality of life will be evaluated by parent completed questionnaire of ECOHIS of Pahel et.al. (2007) at baseline and at the 12 month clinical examination.
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Assessment method [1]
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Timepoint [1]
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evaluated at baseline and after 12 months
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Secondary outcome [2]
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cost-effectiveness of the intervention using cost-consequence analysis. Input costs will be derived from the salary of clinicians and dental assistants and estimates of time spent in
providing care (including re-treatments) will be derived from information recorded in clinical records of study participants and Public Dental Services' Patient Management System. Material costs will also be estimated from clinical records on type and amount of materials used and the cost of materials (obtained from Public Dental Service). Fixed costs (buildings and infrastructure) and overheads and utility costs are common and similar in magnitude to both arms of the trial and will not be considered. Differences in costs and in
effectiveness will be compared in a cost consequence analysis using the primary and secondary effectiveness measures.
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Assessment method [2]
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Timepoint [2]
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Evaluated at the conclusion of the trial after 24 months
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Secondary outcome [3]
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Parent/carer acceptability of care provided. Focus group interviews will be undertaken with a sample of study participants at the conclusion of the study. Nvivo9 computer software will be used to code the transcripts from the focus groups. Emergent themes from the focus groups will then be explored. Transparent validation of emergent themes and content will be performed by using two coders. Thematic analysis will be performed as such an approach allows for contextual differences between perceptions, experiences and belief to be developed and explored.
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Assessment method [3]
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Timepoint [3]
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Evaluated at the conclusion of the trial after 24 months
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Eligibility
Key inclusion criteria
Children aged 4 years or younger.
parent/carer able to communicate effectively in English.
Child has early childhood dental caries.
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Minimum age
No limit
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Maximum age
4
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Child with pain from dental caries and requires urgent/emergency dental treatment.
Child has medical conditions requiring specialist care or require hospitalisation.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consenting parent/child dyad allocated to intervention or comparison using computer-generated randomised blocks. Central trial coordinator will allocate to intervention or control group using table of random numbers for blocks upon receipt of completed and signed consent.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomised blocks.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
nil
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/06/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Health Department Western Australia: Targeted Research Fund
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Address [1]
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Research Development Unit
Department of Health
PO Box 8172 Perth Business Centre WA 6849
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Country [1]
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Australia
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Primary sponsor type
Government body
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Name
Dental Health Services
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Address
43 Mt Henry Road Como, 6152
Western Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of western Australia Human Research ethics Committee
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Ethics committee address [1]
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Human Research Ethics Committee
Research Services, University of Western Australia
35 Stirling Highway, Crawley WA 6009.
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/04/2011
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Approval date [1]
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24/06/2011
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Ethics approval number [1]
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RA/4/1/4765
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Summary
Brief summary
The aim of the study is to compare the effectiveness of school dental therapist treatment of early childhood caries against the standard care within Dental Health Services of dentist provided treatment of early childhood caries among children 4 years of age or younger.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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peter arrow
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Address
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43 Mt Henry Road
Como, 6152
Perth, Western Australia
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Country
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Australia
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Phone
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+61 08 93130600
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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peter arrow
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Address
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43 Mt Henry Road
Como, 6152
Perth, Western Australia
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Country
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Australia
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Phone
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+61 08 93130600
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Current supporting documents:
Updated to:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23222
Other
publications available on request
23817
Other
published manuscripts available
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4355
Study results article
Yes
Evaluation of the Early Childhood Oral Health Impa...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Minimum intervention dentistry approach to managing early childhood caries: a randomized control trial.
2015
https://dx.doi.org/10.1111/cdoe.12176
N.B. These documents automatically identified may not have been verified by the study sponsor.
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