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

Phase 3

Completed

• Conditions: Early Childhood Caries
• Interventions: Drug: Sodium Fluoride Varnish (5%); Drug: SDF; Behavioral: Motivational Interviewing

• Registration Number: NCT05761041
• Lead Sponsor: Alexandria University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-28
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-09
• Primary Completion: 2023-03-30
• Study Completion: 2023-04-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naf + MI	Sodium Fluoride Varnish (5%)	Sodium Fluoride Varnish 5% (Applied biannually) + two MI sessions: baseline face-to-face session and phone call after 3months.
Naf + MI	Motivational Interviewing	Sodium Fluoride Varnish 5% (Applied biannually) + two MI sessions: baseline face-to-face session and phone call after 3months.
SDF	SDF	Silver Diamine fluoride 38% (Applied biannually)

Primary Outcome Measures

Name	Time	Method
Caries Arrest	6 months	Percentage of arrested carious lesions

Secondary Outcome Measures

Name	Time	Method
Parental satisfaction	Baseline and 6 months	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).
Caries Increment	6 months	Number of new carious lesions will be assessed using decayed, missing (due to caries), and filled primary tooth surface index (dmfs)

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt