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
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 11, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedAugust 6, 2019
September 1, 2018
1.8 years
March 11, 2018
August 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Increasing number of new caries lesion from baseline
6 months
Increasing number of new caries lesion from baseline
12 months
Increasing number of new caries lesion from baseline
18 months
Parental satisfaction
2 weeks
Parental satisfaction
18 months
- +5 more secondary outcomes
Study Arms (3)
SDF arm
EXPERIMENTALSDF 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.
Fluoride varnish arm
EXPERIMENTALFluoride varnish arm is application of 5% sodium fluoride varnish on all surface of every tooth.
Combination arm
EXPERIMENTALCombination 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.
Interventions
38% silver diamine fluoride solution
5% sodium fluoride varnish
Eligibility Criteria
You may qualify if:
- School children aged 6- 7 years old.
- Have at least one or more active dentin caries lesions in primary canine/molar.
- Parents give consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry , Khon Kaen University
Khon Kaen, 40002, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kemporn Kitsahawong, DDS., MSc.
Faculty of Dentistry, Khon Kaen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 11, 2018
First Posted
March 29, 2018
Study Start
September 1, 2017
Primary Completion
June 30, 2019
Study Completion
July 31, 2019
Last Updated
August 6, 2019
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share