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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03480516
Other study ID # KKUHE602106
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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