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NCT Number: NCT03480516

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

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.

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Key information

Conditions

Dental Caries in Children Behavior Cost Effectiveness Oral Health Personal Satisfaction Quality of Life Satisfaction

Age range

6 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry , Khon Kaen University

Khon Kaen, 40002, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SDF

Device

38% silver diamine fluoride solution

Other names: Silver diamine fluoride

Fluoride varnish

Device

5% sodium fluoride varnish

Other names: Sodium fluoride varnish

Primary outcomes

  1. Number of arrested caries lesion changed from baseline

    Time frame: 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 outcomes

  1. Increasing number of new caries lesion from baseline

    Time frame: 6 months

    The dental caries status was evaluated at 6 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index

  2. Increasing number of new caries lesion from baseline

    Time frame: 12 months

    The dental caries status was evaluated at 12 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index

  3. Increasing number of new caries lesion from baseline

    Time frame: 18 months

    The dental caries status was evaluated at 18 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index

  4. Parental satisfaction

    Time frame: 2 weeks

    parental satisfaction will be collected, by a seft-administered questionnaire, at 2 weeks.

  5. Parental satisfaction

    Time frame: 18 months

    parental satisfaction will be collected, by a seft-administered questionnaire, at 18 months

  6. Child satisfaction

    Time frame: 6 months

    Child satisfaction will be collected after fluoride application by interview. at 6 months

  7. Child satisfaction

    Time frame: 12 months

    Child satisfaction will be collected after fluoride application by interview. at 12 months

  8. Child satisfaction

    Time frame: 18 months

    Child satisfaction will be collected after fluoride application by interview. at 18 months

  9. Cost Effectiveness

    Time frame: 18 months

    Cost effectiveness analysis of arrested caries lesion and new caries lesion at 18 months

  10. Oral Health-Related Quality of life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2018
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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