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

A

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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