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Clinical Trials/NCT05255913
NCT05255913CompletedNot Applicable

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

Alexandria University1 site in 1 country360 target enrollmentStarted: March 15, 2022Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
360
Locations
1
Primary Endpoint
caries arrest
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 4 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

group 1

Experimental

Intervention: Nanosilver (Drug)

group 2

Active Comparator

Intervention: Silver diamine fluoride (Drug)

Outcomes

Primary Outcomes

caries arrest

Time Frame: 6 months and 1 year

percentage of arresting caries in primary teeth

Secondary Outcomes

  • Comparing parental satisfaction and adverse effects with interventions(6 months)
  • Evaluating oral health related quality of life of children and their families.(6 months and 1 year)
  • Assessing caries increment on remaining teeth in the oral cavity other than the tooth/ teeth receiving the preventive agent(6 months and 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maryam Quritum

dentist

Alexandria University

Study Sites (1)

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