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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480516
• Other study ID #: KKUHE602106
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: September 2018
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• SDF
38% silver diamine fluoride solution
• Fluoride varnish
5% sodium fluoride varnish

Locations

Country	Name	City	State
Thailand	Faculty of Dentistry , Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

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