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

NCT ID: NCT03480516

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-07-31

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

SDF

Intervention Type: DEVICE

38% silver diamine fluoride solution

Fluoride varnish arm

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

Group Type: EXPERIMENTAL

Fluoride varnish

Intervention Type: DEVICE

5% sodium fluoride varnish

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.

Group Type: EXPERIMENTAL

SDF

Intervention Type: DEVICE

38% silver diamine fluoride solution

Fluoride varnish

Intervention Type: DEVICE

5% sodium fluoride varnish

Interventions

SDF

38% silver diamine fluoride solution

Intervention Type: DEVICE

Fluoride varnish

5% sodium fluoride varnish

Intervention Type: DEVICE

Other Intervention Names

Silver diamine fluoride; Sodium fluoride varnish

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Kemporn Kitsahawong

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kemporn Kitsahawong, DDS., MSc.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Khon Kaen University

Locations

Faculty of Dentistry , Khon Kaen University

Khon Kaen, , Thailand

Countries

Thailand

Other Identifiers

KKUHE602106

Identifier Type: -

Identifier Source: org_study_id