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

Early Childhood Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05255913
• Other study ID #: 0265-07/2021
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: August 3, 2023

Study information

• Verified date: September 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: August 3, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 4 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

Drug:
• Nanosilver
preventive material for arresting caries
• Silver diamine fluoride
preventive material for arresting caries

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	caries arrest	percentage of arresting caries in primary teeth	6 months and 1 year
Secondary	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
Secondary	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
Secondary	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