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

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ClinicalTrials.gov Identifier: NCT03480516
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Kemporn Kitsahawong, Khon Kaen University

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
Dental Caries in Children Satisfaction Cost Effectiveness Oral Health Quality of Life Device: SDF Device: Fluoride varnish Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


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 Name: Silver diamine fluoride

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 Name: Sodium fluoride varnish

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 Name: Silver diamine fluoride

Device: Fluoride varnish
5% sodium fluoride varnish
Other Name: Sodium fluoride varnish




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   6 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480516


Locations
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Thailand
Faculty of Dentistry , Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
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Principal Investigator: Kemporn Kitsahawong, DDS., MSc. Faculty of Dentistry, Khon Kaen University

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Responsible Party: Kemporn Kitsahawong, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT03480516     History of Changes
Other Study ID Numbers: KKUHE602106
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kemporn Kitsahawong, Khon Kaen University:
Silver Diamine Fluoride
Sodium Fluoride Varnish
Arrest caries
Caries prevention
Cost Effectiveness
Oral Health
Quality of Life
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Listerine
Fluorides
Sodium Fluoride
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents