Efficacy of Silver Diamine Fluoride and Its Parental Perception

University of Baghdad

Status and phase: Suspended; Phase 3; Phase 2

Conditions: Dental Caries in Children

Treatments: Drug: MI Varnish; Drug: silver diamine fluoride

Study type: Interventional

Funder types: Other

Identifiers

NCT04213573

AMKhammas

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group 1: topical application of silver diamine fluoride

Experimental group

Description:

38% silver diamine fluoride liquid

Treatment:

Drug: silver diamine fluoride

Group 2: topical application of MI varnish.

Active Comparator group

Description:

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

Treatment:

Drug: MI Varnish