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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Dental Caries in Children; Satisfaction; Oral Health; Cost Effectiveness
• Intervention / Treatment: Device: SDF; Device: Fluoride varnish

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

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Faculty of Dentistry , Khon Kaen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Silver diamine fluoride; Device: Fluoride varnish; 5% sodium fluoride varnish; Other Names: Sodium fluoride varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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	12 months
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	18 months
Parental satisfaction	parental satisfaction will be collected, by a seft-administered questionnaire, at 2 weeks.	2 weeks
Parental satisfaction	parental satisfaction will be collected, by a seft-administered questionnaire, at 18 months	18 months
Child satisfaction	Child satisfaction will be collected after fluoride application by interview. at 6 months	6 months
Child satisfaction	Child satisfaction will be collected after fluoride application by interview. at 12 months	12 months
Child satisfaction	Child satisfaction will be collected after fluoride application by interview. at 18 months	18 months
Cost Effectiveness	Cost effectiveness analysis of arrested caries lesion and new caries lesion at 18 months	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	12 months

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Investigators: Principal Investigator: Kemporn Kitsahawong, DDS., MSc., Faculty of Dentistry, Khon Kaen University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: March 11, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Quality of Life; Cost Effectiveness; Oral Health; Silver Diamine Fluoride; Sodium Fluoride Varnish; Arrest caries; Caries prevention
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Sodium Fluoride; Fluorides, Topical
• Other Study ID Numbers: KKUHE602106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No