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

Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries (a Randomized Clinical Trial)

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.

Study Overview

• Status: Completed
• Conditions: Early Childhood Caries
• Intervention / Treatment: Drug: Nanosilver; Drug: Silver diamine fluoride

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 4 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1	Drug: Nanosilver; preventive material for arresting caries
Active Comparator: group 2	Drug: Silver diamine fluoride; preventive material for arresting caries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
caries arrest	percentage of arresting caries in primary teeth	6 months and 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing parental satisfaction and adverse effects with interventions	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	6 months
Evaluating oral health related quality of life of children and their families.	by using the Arabic version of the Early Childhood Oral Health Impact Scale (A-ECOHIS)	6 months and 1 year
Assessing caries increment on remaining teeth in the oral cavity other than the tooth/ teeth receiving the preventive agent	caries increment which is the number of new caries lesions developed over the study period detected using dmfs (change in dmfs score)	6 months and 1 year

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): August 3, 2023

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 23, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Caries arrest, early childhood caries, Nanosilver fluoride
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: 0265-07/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No