The university of Hong Kong
Hong Kong, China
NCT Number: NCT05655286
To compare the effectiveness of the semi-annual application of 38% SDF with two post-treatment protocols in arresting dental caries in preschool children
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Notify Me3 year–4 year
All sexes
Interventional
Not applicable
Hong Kong, China
Methods: The randomized clinical trial will recruit 254 healthy kindergarten children aged 3-4 years old with caries and with parental consent. All the tooth surfaces with carious lesions will receive the semi-annual application of 38% SDF solution. After the treatment, children will be allocated to two groups by an independent research assistant. Two post-treatment protocols are as follows.
Group A - Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children.
Group B - Children are instructed not to eat and drink for at least 30 minutes. Clinical examinations after 6-months will be conducted to assess whether the caries is arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 12-months follow-up. The analysis will determine the significance of differences between the percentage of arrested caries at the various follow-ups.
Significance: This study will help determine the optimal post-op treatment in SDF treatment. The study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Children with active caries will receive 38% silver diamine fluoride treatment
After receiving 38% silver diamine fluoride treatment, Children will be asked not to rinse their mouths for at least 30 minutes.
After receiving 38% silver diamine fluoride treatment, Children will be asked to rinse their mouths immediately.
Time frame: at 12-month follow-up
The proportion of the soft (active) carious tooth lesion surfaces that harden (arrested) at 12 months of follow-up will be measured
The University of Hong Kong
Other
The Effectiveness of Silver Diamine Fluoride Treatment With Different Post-treatment Protocols in Arresting Dental Caries in Primary Teeth of Preschool Children
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