Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood Caries

Early Childhood Caries Clinical Trial

Official title:

Effectiveness of Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification for Arresting Early Childhood Caries: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05761041
• Other study ID #: 0272 - 07 /2021
• Status: Completed
• Phase: Phase 3
• Start date: March 28, 2022
• Est. completion date: April 15, 2023

Study information

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

Clinical Trial Summary

Arresting dental caries using silver diamine fluoride (SDF) has gained attention recently for the management of early childhood caries (ECC). However, black staining is one of its drawbacks. A possible affordable alternative can be Sodium Fluoride (NaF) supported with good oral hygiene induced by parental Motivational Interviewing (MI).

The trial aims to compare the impact of SDF versus NaF supported by MI on lesion activity in preschool children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 15, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 4 Years

Eligibility

Inclusion Criteria:

1. Children aged = 4 years old.

2. 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)

3. Children whose caregivers have means of communication (mobile phones).

4. Completion of an informed consent to participate in the study.

Exclusion Criteria:

1. Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess.

2. Parental refusal to participate in the study.

3. Allergy or sensitivity to silver or any of the materials included in the study.

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

Drug:
• Sodium Fluoride Varnish (5%)
Applied at baseline

Behavioral:
• Motivational Interviewing
Two MI sessions: face-to-face at baseline and phone call at 3 months

Drug:
• SDF
Applied bianually

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Alexandria University	Science, Technology & Innovation Funding Authority (STDF)

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries Arrest	Percentage of arrested carious lesions	6 months
Secondary	Caries Increment	Number of new carious lesions will be assessed using decayed, missing (due to caries), and filled primary tooth surface index (dmfs)	6 months
Secondary	Parental satisfaction	Parents will be asked if application was an easy process, pain free for their child and taste is acceptable. Answers will be on a 5 point Likert scale (Strongly agree, Agree, Neutral , Disagree, Strongly disagree).	Baseline and 6 months