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
ACTRN12616000456459
Ethics application status
Approved
Date submitted
23/03/2016
Date registered
7/04/2016
Date last updated
26/08/2019
Date data sharing statement initially provided
26/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Management of tooth decay in refugee children: a conservative approach
Scientific title
Efficacy of topical silver diamine fluoride application on arresting dental caries in refugee children
Secondary ID [1] 288675 0
Nil known
Universal Trial Number (UTN)
U1111-1180-2684
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental Caries 297882 0
Condition category
Condition code
Oral and Gastrointestinal 298051 298051 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 under 12 years of age presenting to the Refugee Health Service (RHS) will undergo dental assessment as per current protocols. The option of fluoride treatment will be offered to the parents of children presenting with at least one carious lesion. Eligible children will then undergo simple sequential randomisation and single dose controlled application of 0.05ml Silver Diamine Fluoride (SDF) (intervention group) or 0.4ml 5% Sodium Fluoride varnish (NaF) (control group) will be applied to the carious lesions using a micro brush and adequate isolation.

Dental review and SDF or NaF applications will be conducted such that:
- SDF or NaF will be applied to carious lesions on initial screening if the eligibility criteria is satisfied
- SDF or NaF application will then be performed again at 6 months, 12 months and a final review of each carious lesion will be completed at 18 months post-initial application. As such if a carious lesion is detected on initial screening it will receive a total of three SDF or three NaF applications at the aforementioned intervals. The carious lesions will be documented and reviewed at each of these intervals with a final review and dental charting conducted at 18 post initial visit.
Intervention code [1] 294095 0
Prevention
Comparator / control treatment
Following sequential randomisation, fluoride varnish (5% Sodium Fluoride) will be applied to children in the control group at initial visit, 6 months and 12 months with a final review at 18 months.
Control group
Active

Outcomes
Primary outcome [1] 297567 0
The arrest of dental caries:
Progression of dental caries will be assessed using clinical examination, ICDAS classification, clinical photographs and shade comparisons. Dmft scores will also be recorded at baseline and redone throughout the duration of the study at each review.
Timepoint [1] 297567 0
Progression of dental caries will be assessed at each review/SDF application i.e 6 months, 12 months and finally 18 months post-initial SDF application
Secondary outcome [1] 321411 0
Changes in Oral Health-Related Quality of Life will be assessed using Early Childhood Oral Health Impact Scale (ECOHIS) and the Child Oral Health-Related Quality of Life scale (COHRQoL)
Timepoint [1] 321411 0
Quality of life will be assessed using questionnaires at each review appointment i.e 6 months, 12 months and finally 18 months post-initial SDF application
Secondary outcome [2] 322581 0
Prevented fraction as assessed by changes in the dmft index
Timepoint [2] 322581 0
The dmft index of each child will be recorded at baseline and then re-evaluated and recorded at the final 18 month review. Prevented fractions will be calculated by comparing the dmft indices.
Secondary outcome [3] 322582 0
Need for emergency dental treatment: The need or uptake of emergency dental treatment due to teeth that develop pain, abscess and undergo emergency treatment such as extraction will be recorded. Information such as which teeth required emergency treatment, the nature of emergency treatment e.g. extraction under general anaesthesia, service accessed e.g. private clinic or public hospital will be collected.
Timepoint [3] 322582 0
This information will be obtained through clinical examination and information collected from patient history during each review appointment (6 months, 12 months and 18 months)

Eligibility
Key inclusion criteria
- Refugee children under 12 years of age deemed eligible for treatment through the Refugee Health Service i.e. satisfying visa conditions etc set out by the Humanitarian Entrant Health Service
- Children found to have atleast one carious lesion i.e. children who are caries free will not be included, however they may be included if at 6 month review are found to have developed a carious lesion

Minimum age
No limit
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Non-vital teeth (determined by pulpal exposure, presence of an abscess or a sinus, obvious discoloration, and premature hypermobility) will be excluded from treatment as extraction is better indicated in these situations. These cases will be referred for appropriate management through the current referral pathways.
- Children found to be caries free will be excluded from this study. However, they will be reviewed in 6 months and may be included if a carious lesion has developed.
- Parents who do not wish their child to participate or children who refuse treatment will not be included.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple sequential randomisation using computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
An estimated sample size of 100 children per group is required based on an absolute difference of 10% in the rate of caries arrest, with the power of the study set at 90% and with a=0.05 as the statistical significance level. Accounting for an anticipated drop-out rate of 20%, 120 children per group, a total of 240 children will need to be recruited.

Descriptive analysis: PPHs among refugee children, estimated treatment costs, length of stay
Quantitative Analysis: Prevented fraction, caries progression, need for emergency management
Qualitative Analysis: Changes in QoL, analysis of dental treatment burden

Recruitment
Recruitment status
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] 293033 0
University
Name [1] 293033 0
The University of Western Australia
Address [1] 293033 0
17 Monash Ave, Nedlands WA 6009
Country [1] 293033 0
Australia
Primary sponsor type
University
Name
School of Dentistry, University of Western Australia
Address
17 Monash Ave, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 291808 0
None
Name [1] 291808 0
Address [1] 291808 0
Country [1] 291808 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294544 0
Princess Margaret Hospital for Children Human Research Ethics Committee
Ethics committee address [1] 294544 0
Roberts Rd, Subiaco WA 6008
Ethics committee country [1] 294544 0
Australia
Date submitted for ethics approval [1] 294544 0
01/08/2016
Approval date [1] 294544 0
14/11/2016
Ethics approval number [1] 294544 0
2016117EP

Summary
Brief summary
Dental caries (tooth decay) in the early childhood, known as Early Childhood Caries (ECC) can be debilitating, significantly impacting on a child’s growth, nutrition, sleep, learning, appearance and quality of life. Children from refugee backgrounds face significant barriers in accessing timely care and therefore continue to experience significant disparities in oral health. The persisting barriers to seek and provide dental care inevitably leads to emergency hospitalisations and dental extractions.

Topical fluoride varnish application, specifically 5% sodium fluoride varnish (NaF), has been recommended in the prevention and control of dental caries in children. This forms part of current best practice in caries prevention along with provision of oral hygiene and dietary advice. Silver diamine fluoride (SDF) is another topical fluoride modality that has shown to have greater efficacy than NaF and is non-invasive, easy to apply, and effective treatment modality to arrest dental caries in high-risk children.
The aims of this project are to evaluate the:
(i) effectiveness of SDF in arresting carious lesions in refugee children
(ii) quality of life (QoL) changes in refugee children before and after SDF application

Refugee children under the age of 12 years will undergo a dental examination through the RHS, as per current protocols. The option of fluoride treatment will be offered to the parents of children presenting with at least one carious lesion. Eligible children will then undergo simple sequential randomisation and SDF or NaF will be applied to the carious lesions at initial visit, 6 months and 12 months at RHS and final review will be conducted at OHCWA at 18 months. Follow-up QoL surveys, dental charting and intra-oral photographs will be taken to assess changes in the carious lesions.

The expected outcome of this study is to develop the use of SDF as an adjunctive treatment modality for refugee children, thereby improving their quality of life and reducing the need for emergency dental treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64082 0
Dr Jilen Patel
Address 64082 0
School of Dentistry M512
The University of Western Australia
17 Monash Ave, Nedlands WA 6009
Country 64082 0
Australia
Phone 64082 0
+61 8 9346 7868
Fax 64082 0
Email 64082 0
jilen.patel@uwa.edu.au
Contact person for public queries
Name 64083 0
A/Prof Robert Anthonappa
Address 64083 0
School of Dentistry M512
The University of Western Australia
17 Monash Ave, Nedlands WA 6009
Country 64083 0
Australia
Phone 64083 0
+61 8 9346 7868
Fax 64083 0
Email 64083 0
robert.anthonappa@uwa.edu.au
Contact person for scientific queries
Name 64084 0
A/Prof Robert Anthonappa
Address 64084 0
School of Dentistry M512
The University of Western Australia
17 Monash Ave, Nedlands WA 6009
Country 64084 0
Australia
Phone 64084 0
+61 8 9346 7868
Fax 64084 0
Email 64084 0
robert.anthonappa@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per ethical approval
What supporting documents are/will be available?
No other documents available
Summary results
No Results