Efficacy of Silver Diamine Fluoride and Its Parental Perception

University of Baghdad60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Caries in Children

Interventions

silver diamine fluorideDRUG

38% silver diamine fluoride liquid will be applied with a brush

MI VarnishDRUG

topical fluoride varnish with calcium and phosphate

Eligibility

Sex: ALLMin age: 4 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

al-Ameriya dental specialized center

Baghdad, Al-karkh, Iraq

Outcomes

Primary Outcomes

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

Time frame: 2 weeks

Secondary Outcomes

Parent perception

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

Time frame: 0 - 2 weeks

Data from ClinicalTrials.gov

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