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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
6/09/2024
Date data sharing statement initially provided
6/09/2024
Date results information initially provided
6/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Dental therapist treatment of early childhood dental decay among preschool children
Scientific title
Effectiveness of dental therapist treatment of early childhood dental caries among preschool children
Secondary ID [1] 280418 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The treatment of early childhood dental caries 286387 0
Condition category
Condition code
Oral and Gastrointestinal 286636 286636 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 284773 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 287035 0
Quality of restorations will be assessed at 12 months following the criteria of Frencken et.al. (1996) by examining each child participant.
Timepoint [1] 287035 0
Evaluated 12 months after post intervention
Primary outcome [2] 287036 0
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.
Timepoint [2] 287036 0
Evaluated after 12 months
Secondary outcome [1] 297254 0
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.
Timepoint [1] 297254 0
evaluated at baseline and after 12 months
Secondary outcome [2] 297255 0
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.
Timepoint [2] 297255 0
Evaluated at the conclusion of the trial after 24 months
Secondary outcome [3] 297256 0
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.
Timepoint [3] 297256 0
Evaluated at the conclusion of the trial after 24 months

Eligibility
Key inclusion criteria
Children aged 5 years or younger.
parent/carer able to communicate effectively in English.
Child has early childhood dental caries.
Minimum age
No limit
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomised blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
30/06/2012
Actual
12/06/2012
Date of last participant enrolment
Anticipated
Actual
27/11/2013
Date of last data collection
Anticipated
Actual
28/10/2014
Sample size
Target
400
Accrual to date
Final
254
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 285173 0
Government body
Name [1] 285173 0
Health Department Western Australia: Targeted Research Fund
Country [1] 285173 0
Australia
Primary sponsor type
Government body
Name
Dental Health Services
Address
43 Mt Henry Road Como, 6152
Western Australia
Country
Australia
Secondary sponsor category [1] 284041 0
None
Name [1] 284041 0
Address [1] 284041 0
Country [1] 284041 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287180 0
University of Western Australia Human Research ethics Committee
Ethics committee address [1] 287180 0
Human Research Ethics Committee
Research Services, University of Western Australia
35 Stirling Highway, Crawley WA 6009.
Ethics committee country [1] 287180 0
Australia
Date submitted for ethics approval [1] 287180 0
01/04/2011
Approval date [1] 287180 0
24/06/2011
Ethics approval number [1] 287180 0
RA/4/1/4765

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.
Trial website
Trial related presentations / publications
Minimal intervention dentistry for early childhood caries and child dental anxiety: a randomized controlled trial.
Arrow P, Klobas E.
Aust Dent J. 2017 Jun;62(2):200-207.

Cost-effectiveness analysis of the atraumatic restorative treatment-based approach to managing early childhood caries.
Tonmukayakul U, Arrow P.
Community Dent Oral Epidemiol. 2017 Feb;45(1):92-100.

Restorative Outcomes of a Minimally Invasive Restorative Approach Based on Atraumatic Restorative Treatment to Manage Early Childhood Caries: A Randomised Controlled Trial.
Arrow P.
Caries Res. 2016;50(1):1-8.

Child oral health-related quality of life and early childhood caries: a non-inferiority randomized control trial.
Arrow P, Klobas E.
Aust Dent J. 2016 Jun;61(2):227-35.

Responsiveness and sensitivity of the Early Childhood Oral Health Impact Scale to primary dental care for early childhood caries.
Arrow P.
Community Dent Oral Epidemiol. 2016 Feb;44(1):1-10.

Minimum intervention dentistry approach to managing early childhood caries: a randomized control trial.
Arrow P, Klobas E.
Community Dent Oral Epidemiol. 2015 Dec;43(6):511-20.

Evaluation of the Early Childhood Oral Health Impact Scale in an Australian preschool child population.
Arrow P, Klobas E.
Aust Dent J. 2015 Sep;60(3):375-81.
Public notes

Contacts
Principal investigator
Name 34121 0
Dr peter arrow
Address 34121 0
locked bag 15, Bentley delivery centre, 6983, Western Australia
Country 34121 0
Australia
Phone 34121 0
+61 08 93130600
Fax 34121 0
Email 34121 0
[email protected]
Contact person for public queries
Name 17368 0
peter arrow
Address 17368 0
43 Mt Henry Road
Como, 6152
Perth, Western Australia
Country 17368 0
Australia
Phone 17368 0
+61 08 93130600
Fax 17368 0
Email 17368 0
[email protected]
Contact person for scientific queries
Name 8296 0
peter arrow
Address 8296 0
43 Mt Henry Road
Como, 6152
Perth, Western Australia
Country 8296 0
Australia
Phone 8296 0
+61 08 93130600
Fax 8296 0
Email 8296 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Evaluation of the Early Childhood Oral Health Impa... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMinimum intervention dentistry approach to managing early childhood caries: a randomized control trial.2015https://dx.doi.org/10.1111/cdoe.12176
N.B. These documents automatically identified may not have been verified by the study sponsor.