Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries

Not Applicable

Completed

• Conditions: Early Childhood Caries
• Interventions: Drug: Nanosilver; Drug: Silver diamine fluoride

• Registration Number: NCT05255913
• Lead Sponsor: Alexandria University

Brief Summary

Aim of the study: To evaluate and compare the clinical cariostatic efficacy of NSF with 38% SDF solution after sex and twelve months in arresting ECC lesions.

The Null hypothesis will be that no statistically significant difference will be detected between the two groups in the arrest of carious lesions in children with ECC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-25
• Study Start: 2022-03-15
• Primary Completion: 2023-07-25
• Study Completion: 2023-08-03
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-23
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Children younger than 4 years old.
• The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II)
• Completion of an informed consent to participate in the study.

Exclusion Criteria

• Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess, obvious discoloration of the tooth and premature hypermobility.

  • Parental refusal to participate in the study.
  • Allergy or sensitivity to silver or any of the materials included in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	Nanosilver	-
group 2	Silver diamine fluoride	-

Primary Outcome Measures

Name	Time	Method
caries arrest	6 months and 1 year	percentage of arresting caries in primary teeth

Secondary Outcome Measures

Name	Time	Method
Comparing parental satisfaction and adverse effects with interventions	6 months	assessed by a self-rated questionnaire with responses on a 4-point Likert scale ranging from very satisfied, satisfied, unsatisfied, to very unsatisfied - Parents were also asked about adverse effects
Evaluating oral health related quality of life of children and their families.	6 months and 1 year	by using the Arabic version of the Early Childhood Oral Health Impact Scale (A-ECOHIS)
Assessing caries increment on remaining teeth in the oral cavity other than the tooth/ teeth receiving the preventive agent	6 months and 1 year	caries increment which is the number of new caries lesions developed over the study period detected using dmfs (change in dmfs score)

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Alexandria, Egypt