Comparison of Caries Arrested & Prevented Among SDF, NaF Varnish and Combination in Children
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SDF arm 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
38% silver diamine fluoride solution
Other Names:
|
| Experimental: Fluoride varnish arm Fluoride varnish arm is application of 5% sodium fluoride varnish on all surface of every tooth. |
Device: Fluoride varnish
5% sodium fluoride varnish
Other Names:
|
| Experimental: Combination arm 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
38% silver diamine fluoride solution
Other Names:
Device: Fluoride varnish
5% sodium fluoride varnish
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of arrested caries lesion changed from baseline [18 months]
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)
Secondary Outcome Measures
- Increasing number of new caries lesion from baseline [6 months]
The dental caries status was evaluated at 6 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
- Increasing number of new caries lesion from baseline [12 months]
The dental caries status was evaluated at 12 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
- Increasing number of new caries lesion from baseline [18 months]
The dental caries status was evaluated at 18 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
- Parental satisfaction [2 weeks]
parental satisfaction will be collected, by a seft-administered questionnaire, at 2 weeks.
- Parental satisfaction [18 months]
parental satisfaction will be collected, by a seft-administered questionnaire, at 18 months
- Child satisfaction [6 months]
Child satisfaction will be collected after fluoride application by interview. at 6 months
- Child satisfaction [12 months]
Child satisfaction will be collected after fluoride application by interview. at 12 months
- Child satisfaction [18 months]
Child satisfaction will be collected after fluoride application by interview. at 18 months
- Cost Effectiveness [18 months]
Cost effectiveness analysis of arrested caries lesion and new caries lesion at 18 months
- Oral Health-Related Quality of life [12 months]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
School children aged 6- 7 years old.
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Have at least one or more active dentin caries lesions in primary canine/molar.
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Parents give consent.
Exclusion Criteria:
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Uncooperative child
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Allergic reaction to silver or materials containing adhesive.
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Received topical fluoride 3 months prior to enrollment.
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Primary carers are unable to response to questionnaire.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Dentistry , Khon Kaen University | Khon Kaen | Thailand | 40002 |
Sponsors and Collaborators
- Khon Kaen University
Investigators
- Principal Investigator: Kemporn Kitsahawong, DDS., MSc., Faculty of Dentistry, Khon Kaen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KKUHE602106