Efficacy of Silver Diamine Fluoride and Its Parental Perception

Parental Perception of Silver Diamine Fluoride Staining and Its Efficacy on Caries Arrestment in Comparison to Sodium Fluoride With Casein Phosphopeptide-amorphous Calcium Phosphate

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.

Study Overview

• Status: Suspended
• Conditions: Dental Caries in Children
• Intervention / Treatment: Drug: silver diamine fluoride; Drug: MI Varnish

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iraq
  • Al-karkh
    • Baghdad, Al-karkh, Iraq, 10
      • al-Ameriya dental specialized center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: topical application of silver diamine fluoride; 38% silver diamine fluoride liquid	Drug: silver diamine fluoride; 38% silver diamine fluoride liquid will be applied with a brush; Other Names: SDF
Active Comparator: Group 2: topical application of MI varnish.; MI Varnish:5% sodium fluoride varnish which also contains RECALDENT™* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate	Drug: MI Varnish; topical fluoride varnish with calcium and phosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
caries arrestment	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	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent perception	parental perception for silver diamine fluoride staining will be conducted by questionnaire given to the parents	0 - 2 weeks

Collaborators and Investigators

• Sponsor: University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Anticipated): October 20, 2020
• Study Completion (Anticipated): December 20, 2020

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 27, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: AMKhammas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes