CompletedPhase 3

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

Egypt220 participantsStarted 2022-03-01

Plain-language summary

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.

Who can participate

Age range1 Year – 4 Years

SexALL

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Inclusion criteria

✓. Children ≤ 4 years old.
✓. 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.
✓. The Carious lesion has to be active according to Lesion Activity criteria of coronal caries of ICDAS II.
✓. Parental consent for children's participation in the study.

Exclusion criteria

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

What they're measuring

The percentage of arrested carious lesions

Timeframe: 6 months

Trial details

NCT IDNCT05642494

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-30

View on ClinicalTrials.gov More Early Childhood Caries trials