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OpenTrials
Completed

NCT Number: NCT05761041

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

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.

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Key information

Conditions

Early Childhood Caries

Age range

1 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alexandria University

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged ≤ 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)
  • Children whose caregivers have means of communication (mobile phones).
  • 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.
  • Parental refusal to participate in the study.
  • Allergy or sensitivity to silver or any of the materials included in the study.

Treatment and study plan

Sodium Fluoride Varnish (5%)

Drug

Applied at baseline

Motivational Interviewing

Behavioral

Two MI sessions: face-to-face at baseline and phone call at 3 months

SDF

Drug

Applied bianually

Primary outcomes

  1. Caries Arrest

    Time frame: 6 months

    Percentage of arrested carious lesions

Secondary outcomes

  1. Caries Increment

    Time frame: 6 months

    Number of new carious lesions will be assessed using decayed, missing (due to caries), and filled primary tooth surface index (dmfs)

  2. Parental satisfaction

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Collaborators

  • Science,Technology & Innovation Funding Authority, Egypt

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 9, 2023
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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