Clinical trial NCT05642494: Silver Diamine Fluoride(SDF) Versus SDF Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries
Official title: Comparison of the Effectiveness of Silver Diamine Fluoride Versus Silver Diamine Fluoride Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries: A Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Early Childhood Caries
Keywords: ECC
SDF 38%
NaF 5%
preschoolers
Lead sponsor: Alexandria University
Sponsor class: OTHER
Collaborators: name: Science, Technology & Innovation Funding Authority (STDF)
First posted: 2022-12-08
Enrollment: 220
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The percentage of arrested carious lesions
timeFrame: 6 months
Secondary outcomes:
measure: Caries Increment (number of new caries lesions)
timeFrame: 6 months
measure: Parental satisfaction with SDF application
timeFrame: Baseline and at 6 months
measure: Parental satisfaction with SDF application
timeFrame: Baseline and at 6 months
measure: Parental satisfaction with SDF application
timeFrame: Baseline and at 6 months
measure: Parental satisfaction with SDF application
timeFrame: Baseline and at 6 months
measure: Adverse effects reported after application of the interventions
timeFrame: Baseline and at 6 months
measure: Adverse effects reported after application of the interventions
timeFrame: Baseline and at 6 months
measure: Adverse effects reported after application of the interventions
timeFrame: Baseline and at 6 months
measure: Adverse effects reported after application of the interventions
timeFrame: Baseline and at 6 months
measure: Adverse effects reported after application of the interventions
timeFrame: Baseline and at 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty Of Dentistry Alexandria University
Study officials:
affiliation: Alexandria University
name: Enas B Abdellatif, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: