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

NCT05761041 | Completed Phase 3 FDA Drug

• 1 other identifier: 0272 - 07 /2021
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Childhood Caries

Keywords

ECC; 38% SDF; 5% NaF; Motivational Interviewing; Preschoolers

Outcome Measures

Primary Outcomes (1)

• Caries Arrest

  Percentage of arrested carious lesions

  6 months

Secondary Outcomes (2)

• Caries Increment

  6 months

• Parental satisfaction

  Baseline and 6 months

Study Arms (2)

Naf + MI

EXPERIMENTAL

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

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

SDF

ACTIVE COMPARATOR

Silver Diamine fluoride 38% (Applied biannually)

Drug: SDF

Interventions

Sodium Fluoride Varnish (5%) DRUG

Applied at baseline

Naf + MI

Motivational Interviewing BEHAVIORAL

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

Naf + MI

SDF DRUG

Applied bianually

SDF

Eligibility Criteria

• Age: 1 Year - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead
• Science, Technology & Innovation Funding Authority (STDF): collaborator

Study Sites (1)

Alexandria University

Alexandria, Egypt

Location

Related Publications (1)

• Yassin R, Amer H, Tantawi ME. Effectiveness of silver diamine fluoride versus sodium fluoride varnish combined with mother's motivational interviewing for arresting early childhood caries: a randomized clinical trial. BMC Oral Health. 2023 Oct 4;23(1):710. doi: 10.1186/s12903-023-03456-3.

  PMID: 37789300 DERIVED

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 9, 2023
• Study Start: March 28, 2022
• Primary Completion: March 30, 2023
• Study Completion: April 15, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)