Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries
1 other identifier
interventional
360
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2023
CompletedSeptember 26, 2023
September 1, 2023
1.4 years
February 16, 2022
September 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
caries arrest
percentage of arresting caries in primary teeth
6 months and 1 year
Secondary Outcomes (3)
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
Study Arms (2)
group 1
EXPERIMENTALgroup 2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry
Alexandria, Egypt
Related Publications (2)
Quritum M, Abdella A, Amer H, El Desouky LM, El Tantawi M. Effectiveness of nanosilver fluoride and silver diamine fluoride in arresting early childhood caries: a randomized controlled clinical trial. BMC Oral Health. 2024 Jun 18;24(1):701. doi: 10.1186/s12903-024-04406-3.
PMID: 38890627DERIVEDQuritum M, Abdella A, Amer H, El Tantawi M. Effect of silver diamine fluoride and nano silver fluoride on oral health-related quality of life of children with early childhood caries: A randomized clinical trial. J Dent. 2024 Mar;142:104878. doi: 10.1016/j.jdent.2024.104878. Epub 2024 Feb 2.
PMID: 38311016DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dentist
Study Record Dates
First Submitted
February 16, 2022
First Posted
February 25, 2022
Study Start
March 15, 2022
Primary Completion
July 25, 2023
Study Completion
August 3, 2023
Last Updated
September 26, 2023
Record last verified: 2023-09