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

Sponsor

Alexandria University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05761041

Collaborator

Science, Technology & Innovation Funding Authority (STDF) (Other)

140

Enrollment

Location

Arms

12.6

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Early Childhood Caries	Drug: Sodium Fluoride Varnish (5%) Behavioral: Motivational Interviewing Drug: SDF	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 13, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Naf + MI Sodium Fluoride Varnish 5% (Applied biannually) + two MI sessions: baseline face-to-face session and phone call after 3months.	Drug: Sodium Fluoride Varnish (5%) Applied at baseline Behavioral: Motivational Interviewing Two MI sessions: face-to-face at baseline and phone call at 3 months
Active Comparator: SDF Silver Diamine fluoride 38% (Applied biannually)	Drug: SDF Applied bianually

Arm

Intervention/Treatment

Experimental: Naf + MI

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

Drug: Sodium Fluoride Varnish (5%)

Applied at baseline

Behavioral: Motivational Interviewing

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

Active Comparator: SDF

Silver Diamine fluoride 38% (Applied biannually)

Drug: SDF

Applied bianually

Outcome Measures

Primary Outcome Measures

Caries Arrest [6 months]
Percentage of arrested carious lesions

Secondary Outcome Measures

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)
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 4 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.