RecruitingPhase 4ACTRN12616000456459

Management of tooth decay in refugee children: a conservative approach

Efficacy of topical silver diamine fluoride application on arresting dental caries in refugee children


Sponsor

School of Dentistry, University of Western Australia

Enrollment

240 participants

Start Date

Sep 11, 2017

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMax Age: 12 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing two different fluoride treatments to prevent and stop tooth decay (dental caries) in refugee children. One treatment is a traditional fluoride varnish (sodium fluoride, or NaF), and the other is silver diamine fluoride (SDF), which may be more effective and is easier to apply. The aim is to find a non-invasive, effective way to treat tooth decay in refugee children who may have limited access to regular dental care. You may be eligible if: - Your child is a refugee under 12 years of age - Your child has been seen through the Refugee Health Service and meets visa eligibility - Your child has at least one cavity (carious lesion) detected during examination You may NOT be eligible if: - Your child has teeth that are not alive (non-vital), such as those with an abscess or severe infection — these would need extraction instead - Your child has no cavities (though they may be checked again in 6 months) - You or your child does not wish to participate Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 o

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.


Locations(1)

WA, Australia

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ACTRN12616000456459


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