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

Primary Purpose

Dental Caries in Children, Satisfaction, Cost Effectiveness

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
SDF
Fluoride varnish
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries in Children focused on measuring Silver Diamine Fluoride, Sodium Fluoride Varnish, Arrest caries, Caries prevention, Cost Effectiveness, Oral Health, Quality of Life

Eligibility Criteria

6 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Dentistry , Khon Kaen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SDF arm

Fluoride varnish arm

Combination arm

Arm Description

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.

Fluoride varnish arm is application of 5% sodium fluoride varnish on all surface of every tooth.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Increasing number of new caries lesion from baseline
The dental caries status was evaluated at 6 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
Increasing number of new caries lesion from baseline
The dental caries status was evaluated at 12 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
Increasing number of new caries lesion from baseline
The dental caries status was evaluated at 18 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
Parental satisfaction
parental satisfaction will be collected, by a seft-administered questionnaire, at 2 weeks.
Parental satisfaction
parental satisfaction will be collected, by a seft-administered questionnaire, at 18 months
Child satisfaction
Child satisfaction will be collected after fluoride application by interview. at 6 months
Child satisfaction
Child satisfaction will be collected after fluoride application by interview. at 12 months
Child satisfaction
Child satisfaction will be collected after fluoride application by interview. at 18 months
Cost Effectiveness
Cost effectiveness analysis of arrested caries lesion and new caries lesion at 18 months
Oral Health-Related Quality of life
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

Full Information

First Posted
March 11, 2018
Last Updated
August 5, 2019
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT03480516
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SDF arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Fluoride varnish arm
Arm Type
Experimental
Arm Description
Fluoride varnish arm is application of 5% sodium fluoride varnish on all surface of every tooth.
Arm Title
Combination arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SDF
Other Intervention Name(s)
Silver diamine fluoride
Intervention Description
38% silver diamine fluoride solution
Intervention Type
Device
Intervention Name(s)
Fluoride varnish
Other Intervention Name(s)
Sodium fluoride varnish
Intervention Description
5% sodium fluoride varnish
Primary Outcome Measure Information:
Title
Number of arrested caries lesion changed from baseline
Description
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)
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Increasing number of new caries lesion from baseline
Description
The dental caries status was evaluated at 6 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
Time Frame
6 months
Title
Increasing number of new caries lesion from baseline
Description
The dental caries status was evaluated at 12 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
Time Frame
12 months
Title
Increasing number of new caries lesion from baseline
Description
The dental caries status was evaluated at 18 months after fluoride application. Evaluation criteria included decay(d), missing(m), filling(f) index
Time Frame
18 months
Title
Parental satisfaction
Description
parental satisfaction will be collected, by a seft-administered questionnaire, at 2 weeks.
Time Frame
2 weeks
Title
Parental satisfaction
Description
parental satisfaction will be collected, by a seft-administered questionnaire, at 18 months
Time Frame
18 months
Title
Child satisfaction
Description
Child satisfaction will be collected after fluoride application by interview. at 6 months
Time Frame
6 months
Title
Child satisfaction
Description
Child satisfaction will be collected after fluoride application by interview. at 12 months
Time Frame
12 months
Title
Child satisfaction
Description
Child satisfaction will be collected after fluoride application by interview. at 18 months
Time Frame
18 months
Title
Cost Effectiveness
Description
Cost effectiveness analysis of arrested caries lesion and new caries lesion at 18 months
Time Frame
18 months
Title
Oral Health-Related Quality of life
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kemporn Kitsahawong, DDS., MSc.
Organizational Affiliation
Faculty of Dentistry, Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry , Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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

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