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Trial registered on ANZCTR


Registration number
ACTRN12616001124426
Ethics application status
Approved
Date submitted
15/08/2016
Date registered
18/08/2016
Date last updated
7/07/2020
Date data sharing statement initially provided
5/06/2019
Date results provided
7/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of treating of early childhood dental decay using minimally invasive Atraumatic Restorative Treatment-based approach
Scientific title
Minimum Intervention Dentistry—Atraumatic Restorative Treatment-based (ART-based) Approach to Manage Early Childhood Caries
Secondary ID [1] 289935 0
Nil
Universal Trial Number (UTN)
U1111-1186-4674
Trial acronym
GA_ART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental decay 299914 0
early childhood dental decay 299915 0
Condition category
Condition code
Oral and Gastrointestinal 299812 299812 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
Children with early childhood dental decay (<72 months age) on a wait list for treatment under general anaesthesia at the Oral Health Centre of Western Australia (OHCWA) will be randomised into standard care (oral rehabilitation under general anaesthesia) or test care (minimally invasive dental treatment using the Atraumatic Restorative Treatment approach). Children in the test group will be treated by dental therapists with at least 5 years post-graduate experience, using the ART-based approach, using hand instruments to remove dental decay and restoring of the prepared cavity with glass-ionomer cement or stainless steel crowns using the Hall technique. The procedure will take approximately 30 minutes for each appointment for treatment and will be undertaken in school dental service dental clinics. Test group children will also be provided with preventive care including fluoride varnish on the remaining at risk tooth surfaces and fissure sealing of at risk chewing tooth surfaces at baseline during the 30 minute appointments, and at each recall checkups. Six monthly dental checkups will be instituted as part of the oral care program to monitor changes in oral health status and further appointments made to affect preventive care and repair of restorations as needed for 12 months post enrolment. The type of treatments provided and attendance at appointments will be reviewed based on clinical notes.
Intervention code [1] 295616 0
Treatment: Surgery
Intervention code [2] 295617 0
Prevention
Comparator / control treatment
Children in the control group will be managed for the dental conditions by oral rehabilitation under general anaesthesia (including restorations of decayed teeth and any other care as determined by the treating clinicians and reviewed as per the prevailing protocols within OHCWA. The treatments will be undertaken at a public hospital by staff specialist paediatric dentists or trainee paediatric dentists at OHCWA. The time for treatment under general anaesthesia will vary depending on the extent of treatment required and may range between 0.5-1.0 hrs.
Control group
Active

Outcomes
Primary outcome [1] 299285 0
Proportion of children with ECC successfully managed in each arm of the trial by reviewing case notes to determine the number of children re-referred for specialist paediatric dental care under general anaesthesia.
Timepoint [1] 299285 0
12 months post-treatment
Secondary outcome [1] 326734 0
changes in oral health related quality of life using the Early Childhood Oral Health Impact Scale
Timepoint [1] 326734 0
immediately post-treatment and at 12 months post-treatment
Secondary outcome [2] 326735 0
dental decay increment using the International Caries Detection and Assessment System (ICDAS) by examiners blind to group allocation status.
Timepoint [2] 326735 0
12 months post treatment
Secondary outcome [3] 326736 0
incidence of dental infections will be determined through parent report of attendance for dental infections out of scheduled review appointments and review of clinical case notes.
Timepoint [3] 326736 0
12 months post treatment
Secondary outcome [4] 326737 0
changes in child dental anxiety will be determined through parental report of child dental anxiety using the Faces–Modified Child Dental Anxiety Scale.
Timepoint [4] 326737 0
immediate post treatment and 12 months post treatment

Eligibility
Key inclusion criteria
children younger than 72 months of age with early childhood dental decay and recommended for oral rehabilitation under general anaesthesia.
Minimum age
No limit
Maximum age
72 Months
Sex
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. Children unable to attend metropolitan Perth school dental service clinics for appointments.

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)
participants will return consent and questionnaire to a centrally located project coordinator who will allocate using random permuted block into test or control
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
blinding of participants and clinicians into treatment groups will not be possible. Post treatment clinical assessment will be undertaken by examiners blind to group allocation status of participants.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimation is based on detecting a 33% change in the childhood oral health quality of life. A recently completed study in WA found COHRQoL using the ECOHIS of children with ECC in a primary care setting to be 11.1 (SD 8.2). The baseline COHRQoL of children on GA list was estimated at 15; 33% poorer COHRQoL than children with ECC in primary care settings. To detect a 33% difference in COHRQoL at 90 percent power and alpha at 0.05 would require a sample size of 65. Allowing for a 33% loss to follow-up at 12 months increased the estimated required sample size to 100 in each arm of the trial. This sample size would also have sufficient power (0.9) to demonstrate the non-inferiority of treatment outcomes between two arms of the study if the test arm was at most 20% less successful than the control (assuming 95% successfully treated in control).
Data will be anlaysed on intention to treat and per protocol basis using parametric and non-parametric tests as appropriate. Descriptive statistics will be presented and baseline variables will be compared between groups to test for fairness with respect to the randomisation. Grouped outcome measures will be compared between groups using chi-square statistics, and mean scores will be tested using paired (within group) and unpaired (between groups) parametric and non-parametric tests. Multivariate analysis will use linear regression for continuous variables and Poisson regression (negative binomial regression for over-dispersed data) for count variables to control for possible inter-group imbalances. Multiple imputations will be undertaken to manage missing data. 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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2016
Actual
13/06/2017
Date of last participant enrolment
Anticipated
31/07/2018
Actual
27/08/2018
Date of last data collection
Anticipated
27/08/2019
Actual
27/08/2019
Sample size
Target
200
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294307 0
Government body
Name [1] 294307 0
Telethon–Perth Children's Hospital Research Fund
Country [1] 294307 0
Australia
Funding source category [2] 294308 0
Government body
Name [2] 294308 0
Dental Health Services
Country [2] 294308 0
Australia
Primary sponsor type
Government body
Name
Dental Health Services
Address
Locked Bag 15, Bentley Delivery Centre, 6093
Western Australia
Country
Australia
Secondary sponsor category [1] 293148 0
University
Name [1] 293148 0
University of Western Australia, Oral Health Centre of Western Australia
Address [1] 293148 0
17 Monash Avenue
Nedlands, Perth
Western Australia 6009
Country [1] 293148 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295734 0
Princess Margaret Hospital Human Research Ethics Committee
Ethics committee address [1] 295734 0
Ethics committee country [1] 295734 0
Australia
Date submitted for ethics approval [1] 295734 0
01/09/2016
Approval date [1] 295734 0
16/02/2017
Ethics approval number [1] 295734 0
HREC Ref: 2016143EP

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

Contacts
Principal investigator
Name 68266 0
Dr peter arrow
Address 68266 0
Dental Health Services, Locked Bag 15, Bentley Delivery Centre, 6983, Western Australia
Country 68266 0
Australia
Phone 68266 0
+61 8 93130600
Fax 68266 0
+61 8 93131302
Email 68266 0
parrow@ozemail.com.au
Contact person for public queries
Name 68267 0
peter arrow
Address 68267 0
Dental Health Services, Locked Bag 15, Bentley Delivery Centre, 6983, Western Australia
Country 68267 0
Australia
Phone 68267 0
+61 8 93130600
Fax 68267 0
+61 8 93131302
Email 68267 0
parrow@ozemail.com.au
Contact person for scientific queries
Name 68268 0
peter arrow
Address 68268 0
Dental Health Services, Locked Bag 15, Bentley Delivery Centre, 6983, Western Australia
Country 68268 0
Australia
Phone 68268 0
+61 8 93130600
Fax 68268 0
+61 8 93131302
Email 68268 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


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
SourceTitleYear of PublicationDOI
EmbaseAtraumatic restorative treatments improve child oral health-related quality of life: A noninferiority randomized controlled trial.2020https://dx.doi.org/10.1111/cdoe.12539
Dimensions AIAtraumatic restorative treatments reduce the need for dental general anaesthesia: a non-inferiority randomized, controlled trial2020https://doi.org/10.1111/adj.12749
N.B. These documents automatically identified may not have been verified by the study sponsor.