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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03480516
Enrollment
300
Registered
2018-03-29
Start date
2017-09-01
Completion date
2019-07-31
Last updated
2019-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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

Interventions

DEVICESDF

38% silver diamine fluoride solution

DEVICEFluoride varnish

5% sodium fluoride varnish

Sponsors

Khon Kaen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Years to 7 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of arrested caries lesion changed from baseline18 monthsNumber 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

MeasureTime frameDescription
Increasing number of new caries lesion from baseline6 monthsThe dental caries status was evaluated at 6 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
Parental satisfaction2 weeksparental satisfaction will be collected, by a seft-administered questionnaire, at 2 weeks.
Child satisfaction6 monthsChild satisfaction will be collected after fluoride application by interview. at 6 months
Cost Effectiveness18 monthsCost effectiveness analysis of arrested caries lesion and new caries lesion at 18 months
Oral Health-Related Quality of life12 monthsOral health related quality of life in children is being measured using the Child-Oral Impacts on Daily Performance Index (Child-OIDP) at 12 months

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026