An interventional study of SDF and Fluoride varnish in Dental Caries in Children, Satisfaction and Cost Effectiveness, sponsored by Khon Kaen University. Completed at 1 site in Thailand. Open to participants aged 6 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-06.
Sponsored by Khon Kaen University · Not applicable, Interventional, and Treatment
Tooth decay is one of the most common chronic infectious disease found in children worldwide and if left untreated, is rapidly progress. Severe tooth decay in children is not only affect child's health and school performance, but also has impact on the family well-being. Oral rehabilitation in children requires time, resources and effort of dental specialists, the child and parents. Caries is a destructive condition of organic and inorganic components of the tooth structures but reversible and most importantly, preventable. Topical fluoride therapy, delivered by dentists has been effectively used to speed up the repair process as well as to strengthen the surface of intact tooth structure. Topical fluoride is available in various preparations. Regular application of sodium fluoride varnish is every three months, by far, considered as effective method in preventing new caries, particularly in the high-risk children. It has the advantage of containing therapeutic concentration of fluoride and ability to flow over and stick to the tooth surface. Whereas silver ion and relatively higher fluoride concentration in Silver Diamine Fluoride (SDF) has been shown to be the most effective in harden the decay, stop the caries progress and eliminate pathogenic bacteria. It can be hypothesize that when use in combination in school children, both reagents might have synergistic effect on arresting existing caries as well as preventing new caries.
Fluoride varnish is a good choice to consider. For caries prevention in young children, It has high efficacy in caries prevention.
Fluoride varnish has a high F concentration and prolong contact time with enamel, So it can prevent new caries and remineralize initial enamel caries. Silver diamine fluoride solution is effective in arresting dentine caries. Silver diamine fluoride has high fluoride concentration and contain silver ion. when apply dentine caries or cavitated caries can increase hardness of dentine and arresting caries.
When use in combination, it might enhance, the Efficacy in Arresting and Preventing Dental Caries in children
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Exclusion Criteria:
SDF arm is application of 38% silver diamine fluoride solution (SDF) on cavitated caries in primary molar, , cavities in anterior teeth will be applied only on additional consent obtained.
Device: SDF
Fluoride varnish arm is application of 5% sodium fluoride varnish on all surface of every tooth.
Device: Fluoride varnish
Combination arm is application of 38% silver diamine fluoride solution(SDF) on cavitated caries in primary molar, , cavities in anterior teeth will be applied only on additional consent obtained and then apply of 5% sodium fluoride varnish on all surface of every tooth.
Device: SDF · Device: Fluoride varnish
38% silver diamine fluoride solution
Also known as: Silver diamine fluoride
5% sodium fluoride varnish
Also known as: Sodium fluoride varnish
Number of arrested caries lesion changed from baseline
Number of arrested caries lesion changed from baseline. The arresting dentine caries lesion was evaluated at 18 months after first application. Evaluation criteria included the condition of the hardness and discoloration of carious lesion. The carious lesion was re-categorized as a binary outcome: Dental caries (active/inactive)
Time frame: 18 months
Increasing number of new caries lesion from baseline
The dental caries status was evaluated at 6 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
Time frame: 6 months
Increasing number of new caries lesion from baseline
The dental caries status was evaluated at 12 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
Time frame: 12 months
Increasing number of new caries lesion from baseline
The dental caries status was evaluated at 18 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
Time frame: 18 months
Parental satisfaction
parental satisfaction will be collected, by a seft-administered questionnaire, at 2 weeks.
Time frame: 2 weeks
Parental satisfaction
parental satisfaction will be collected, by a seft-administered questionnaire, at 18 months
Time frame: 18 months
Child satisfaction
Child satisfaction will be collected after fluoride application by interview. at 6 months
Time frame: 6 months
Child satisfaction
Child satisfaction will be collected after fluoride application by interview. at 12 months
Time frame: 12 months
Child satisfaction
Child satisfaction will be collected after fluoride application by interview. at 18 months
Time frame: 18 months
Cost Effectiveness
Cost effectiveness analysis of arrested caries lesion and new caries lesion at 18 months
Time frame: 18 months
Oral Health-Related Quality of life
Oral health related quality of life in children is being measured using the Child-Oral Impacts on Daily Performance Index (Child-OIDP) at 12 months
Time frame: 12 months
Plan to share: No
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