Clinical trial NCT03480516: Comparison of Caries Arrested & Prevented Among SDF, NaF Varnish and Combination in Children
Official title: Efficacy of Silver Diamine Fluoride (SDF) and Fluoride Varnish in Arresting and Preventing Dental Caries in Primary School Children: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Satisfaction
Cost Effectiveness
Oral Health
Quality of Life
Keywords: Silver Diamine Fluoride
Sodium Fluoride Varnish
Arrest caries
Caries prevention
Cost Effectiveness
Oral Health
Quality of Life
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of arrested caries lesion changed from baseline
timeFrame: 18 months
Secondary outcomes:
measure: Increasing number of new caries lesion from baseline
timeFrame: 6 months
measure: Increasing number of new caries lesion from baseline
timeFrame: 12 months
measure: Increasing number of new caries lesion from baseline
timeFrame: 18 months
measure: Parental satisfaction
timeFrame: 2 weeks
measure: Parental satisfaction
timeFrame: 18 months
measure: Child satisfaction
timeFrame: 6 months
measure: Child satisfaction
timeFrame: 12 months
measure: Child satisfaction
timeFrame: 18 months
measure: Cost Effectiveness
timeFrame: 18 months
measure: Oral Health-Related Quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Faculty of Dentistry , Khon Kaen University
Study officials:
affiliation: Faculty of Dentistry, Khon Kaen University
name: Kemporn Kitsahawong, DDS., MSc.
role: PRINCIPAL_INVESTIGATOR
References: