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

Alexandria University

Status and phase: Completed; Phase 3

Conditions: Early Childhood Caries

Treatments: Drug: SDF; Drug: Sodium Fluoride Varnish (5%); Behavioral: Motivational Interviewing

Study type: Interventional

Funder types: Other

Identifiers

NCT05761041

0272 - 07 /2021

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 1 to 4 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Naf + MI

Experimental group

Description:

Sodium Fluoride Varnish 5% (Applied biannually) + two MI sessions: baseline face-to-face session and phone call after 3months.

Treatment:

Drug: Sodium Fluoride Varnish (5%)

Behavioral: Motivational Interviewing

SDF

Active Comparator group

Description:

Silver Diamine fluoride 38% (Applied biannually)

Treatment:

Drug: SDF