Silver Diamine Fluoride(SDF) Versus SDF Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries

Alexandria University

Status and phase: Completed; Phase 3

Conditions: Early Childhood Caries

Treatments: Device: SDF; Device: NaF

Study type: Interventional

Funder types: Other

Identifiers

NCT05642494

0272-07/2021

Details and patient eligibility

About

Early childhood caries (ECC) is the most common chronic childhood disease worldwide. Early restorative intervention may treat the disease but this is often difficult especially with uncooperative children so it may be left untreated. Remineralization of affected dentin using silver diamine fluoride (SDF) can arrest these lesions.

This trial aims to compare the effectiveness of 38% SDF solution versus 38% SDF solution with 5% sodium fluoride (NaF) varnish after six months in arresting ECC lesions.

Enrollment: 220 patients

Sex: All

Ages: 1 to 4 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children ≤ 4 years old.
2. The presence of at least one carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II, Appendix 1, Table 1), detected by visual examination.
3. The Carious lesion has to be active according to Lesion Activity criteria of coronal caries of ICDAS II.
4. Parental consent for children's participation in the study.

Exclusion criteria

1. Children reporting spontaneous or elicited pain from caries, or showing any signs of pulpal infection, swelling and/or abscess.
2. Children showing a definite negative behavior (Score 1 Frankel's classification) during clinical examination.
3. Allergy or sensitivity to silver or any of the materials included in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups

SDF+NaF

Experimental group

Description:

Silver Diamine fluoride 38% (Applied biannually)+ Sodium Fluoride Varnish 5% (Applied every 3 months)

Treatment:

Device: SDF

Device: NaF

SDF

Active Comparator group

Description:

Silver Diamine fluoride 38% (Applied biannually)

Treatment:

Device: SDF