Efficacy of Silver Diamine Fluoride and Its Parental Perception

Dental Caries in Children Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04213573
• Other study ID #: AMKhammas
• Status: Suspended
• Phase: Phase 2/Phase 3
• Start date: January 21, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: March 2020
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: December 20, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Drug:
• silver diamine fluoride
38% silver diamine fluoride liquid will be applied with a brush
• MI Varnish
topical fluoride varnish with calcium and phosphate

Locations

Country	Name	City	State
Iraq	al-Ameriya dental specialized center	Baghdad	Al-karkh

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Parent perception	parental perception for silver diamine fluoride staining will be conducted by questionnaire given to the parents	0 - 2 weeks