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Efficacy of Silver Diamine Fluoride and Its Parental Perception

Primary Purpose

Dental Caries in Children

Status
Suspended
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
silver diamine fluoride
MI Varnish
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries in Children

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • al-Ameriya dental specialized center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: topical application of silver diamine fluoride

Group 2: topical application of MI varnish.

Arm Description

38% silver diamine fluoride liquid

MI Varnish:5% sodium fluoride varnish which also contains RECALDENT™* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Parent perception
parental perception for silver diamine fluoride staining will be conducted by questionnaire given to the parents

Full Information

First Posted
December 18, 2019
Last Updated
March 24, 2020
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT04213573
Brief Title
Efficacy of Silver Diamine Fluoride and Its Parental Perception
Official Title
Parental Perception of Silver Diamine Fluoride Staining and Its Efficacy on Caries Arrestment in Comparison to Sodium Fluoride With Casein Phosphopeptide-amorphous Calcium Phosphate
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Suspended
Why Stopped
because of corona virus epidemic
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
October 20, 2020 (Anticipated)
Study Completion Date
December 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: topical application of silver diamine fluoride
Arm Type
Experimental
Arm Description
38% silver diamine fluoride liquid
Arm Title
Group 2: topical application of MI varnish.
Arm Type
Active Comparator
Arm Description
MI Varnish:5% sodium fluoride varnish which also contains RECALDENT™* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate
Intervention Type
Drug
Intervention Name(s)
silver diamine fluoride
Other Intervention Name(s)
SDF
Intervention Description
38% silver diamine fluoride liquid will be applied with a brush
Intervention Type
Drug
Intervention Name(s)
MI Varnish
Intervention Description
topical fluoride varnish with calcium and phosphate
Primary Outcome Measure Information:
Title
caries arrestment
Description
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
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Parent perception
Description
parental perception for silver diamine fluoride staining will be conducted by questionnaire given to the parents
Time Frame
0 - 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Normal healthy children without any systemic disease ASA 1 physical status. Children with at least one carious dentin lesion in their primary teeth, code 5 (ICDAS II) Exclusion Criteria: Children who suffer from major systemic diseases and require long term medications. Children refuse the study intervention. Children with silver or milk product sensitivity. Presence of any gingival or perioral ulceration or stomatitis. Tooth with abscess, fistula or severe pain.
Facility Information:
Facility Name
al-Ameriya dental specialized center
City
Baghdad
State/Province
Al-karkh
ZIP/Postal Code
10
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy of Silver Diamine Fluoride and Its Parental Perception

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