Efficacy of Silver Diamine Fluoride and Its Parental Perception

Phase 2

Suspended

• Conditions: Dental Caries in Children
• Interventions: Drug: silver diamine fluoride; Drug: MI Varnish

• Registration Number: NCT04213573
• Lead Sponsor: University of Baghdad

Brief Summary

This randomized clinical trial aims to compare the effectiveness of two topical fluoride application protocols, namely 38% silver diamine fluoride and sodium fluoride with added casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in arresting dental caries in children.

Detailed Description

The present randomized clinical study is aiming to evaluate the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions when compared to MI Varnish a 5% sodium fluoride varnish which also contains RECALDENT™\* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate. For this, healthy children aged 4-8 years with at least one active dentin carious lesion will be allocated randomly to one of two treatment groups: Group (1) SDF and Group (2) MI Varnish. Each participant will be assigned to one treatment group to avoid the possible synergistic effect of the different agents.

Parents/ guardians of each child will be fully informed regarding the study design, objectives and probable advantages and side effects especially the black discoloration of SDF before their involvement by written consent. The International Caries Detection and Assessment System (ICDAS II) will be used to determine caries diagnosis and activity.visual and tactile examination will be done with a WHO probe to assess the primary outcome. the secondary outcome will be conducted by a questionnaire given to the parents.

Study Timeline

• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-27
• Study First Posted: 2019-12-30
• Study Start: 2020-01-21
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26
• Primary Completion: 2020-10-20
• Study Completion: 2020-12-20

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Normal healthy children without any systemic disease ASA 1 physical status.
2. Children with at least one carious dentin lesion in their primary teeth, code 5 (ICDAS II)

Exclusion Criteria

1. Children who suffer from major systemic diseases and require long term medications.
2. Children refuse the study intervention.
3. Children with silver or milk product sensitivity.
4. Presence of any gingival or perioral ulceration or stomatitis.
5. Tooth with abscess, fistula or severe pain.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: topical application of silver diamine fluoride	silver diamine fluoride	38% silver diamine fluoride liquid
Group 2: topical application of MI varnish.	MI Varnish	MI Varnish:5% sodium fluoride varnish which also contains RECALDENT™\* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate

Primary Outcome Measures

Name	Time	Method
caries arrestment	2 weeks	The measure will be done using international caries detection and assessment system II (ICDAS II) criteria for diagnosing active and arrested caries by WHO probe

Secondary Outcome Measures

Name	Time	Method
Parent perception	0 - 2 weeks	parental perception for silver diamine fluoride staining will be conducted by questionnaire given to the parents

Trial Locations

Locations (1)

al-Ameriya dental specialized center; 🇮🇶 Baghdad, Al-karkh, Iraq