None listed
Conditions
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.
Interventions
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 t
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.
Sponsors
School of Dentistry, University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 12 Years
Healthy volunteers
Yes
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
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.
Outcome results
None listed