Comparison of Caries Arrested & Prevented Among SDF, NaF Varnish and Combination in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Efficacy of Silver Diamine Fluoride (SDF) and Fluoride Varnish in Arresting and Preventing Dental Caries in Primary School Children: Randomized Controlled Clinical Trial

Conditions
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Quality of Life, Dental Caries in Children, Satisfaction, Cost Effectiveness, Oral Health

Intervention / Treatment
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* Device: SDF
* Device: Fluoride varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: School children aged 6- 7 years old. Have at least one or more active dentin caries lesions in primary canine/molar. Parents give consent. Exclusion Criteria: Uncooperative child Allergic reaction to silver or materials containing adhesive. Received topical fluoride 3 months prior to enrollment. Primary carers are unable to response to questionnaire.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SDF arm<br>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<br>* 38% silver diamine fluoride solution<br>* Other names: Silver diamine fluoride;|
| Experimental: Fluoride varnish arm<br>Fluoride varnish arm is application of 5% sodium fluoride varnish on all surface of every tooth. | Device: Fluoride varnish<br>* 5% sodium fluoride varnish<br>* Other names: Sodium fluoride varnish;|
| Experimental: Combination arm<br>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<br>* 38% silver diamine fluoride solution<br>* Other names: Silver diamine fluoride;Device: Fluoride varnish<br>* 5% sodium fluoride varnish<br>* Other names: Sodium fluoride varnish;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 18 months | 
| Parental satisfaction | parental satisfaction will be collected, by a seft-administered questionnaire, at 2 weeks. | 2 weeks | 
| Parental satisfaction | parental satisfaction will be collected, by a seft-administered questionnaire, at 18 months | 18 months | 
| Child satisfaction | Child satisfaction will be collected after fluoride application by interview. at 6 months | 6 months | 
| Child satisfaction | Child satisfaction will be collected after fluoride application by interview. at 12 months | 12 months | 
| Child satisfaction | Child satisfaction will be collected after fluoride application by interview. at 18 months | 18 months | 
| Cost Effectiveness | Cost effectiveness analysis of arrested caries lesion and new caries lesion at 18 months | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Silver Diamine Fluoride, Sodium Fluoride Varnish, Arrest caries, Caries prevention, Cost Effectiveness, Oral Health, Quality of Life