Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Young Children

October University for Modern Sciences and Arts

Status: Not yet enrolling

Conditions: Early Childhood Caries (ECC); Active Dentin Caries in Primary Molars

Treatments: Drug: Nano-Silver Fluoride; Drug: Silver Diamine Fluoride

Study type: Interventional

Funder types: Other

Identifiers

NCT07382245

Khaled SDF

Details and patient eligibility

About

Early childhood caries is a major public health problem affecting preschool children worldwide. Silver Diamine Fluoride is a well-established non-invasive treatment for arresting caries; however, it causes black discoloration of treated lesions. Nano-Silver Fluoride has been introduced as an alternative that may arrest caries without discoloration.

This randomized clinical trial aims to compare the efficacy of Silver Diamine Fluoride and Nano-Silver Fluoride in arresting active dentin caries in primary teeth and to assess discoloration, post-operative pain, and parental satisfaction over a 12-month follow-up period.

Full description

This randomized clinical trial will be conducted on 30 children aged 3-5 years attending the outpatient clinic of Pediatric Dentistry, Faculty of Dentistry, Suez Canal University. Children with active dentin caries in primary molars will be randomly allocated into two groups: Silver Diamine Fluoride group and Nano-Silver Fluoride group.

Both materials will be applied topically without caries excavation. Clinical evaluation will be performed at baseline and at 1, 3, 6, 9, and 12 months using ICDAS criteria, visual and tactile examination, assessment of post-operative pain, discoloration through standardized photographs, and parental satisfaction questionnaires.

The primary outcome is caries arrest. Secondary outcomes include discoloration, pain, and parental satisfaction.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Apparently healthy children.
• Children with age ranged from 3-5 years from both genders.
• Children who refused dental treatment with Frankl Behavior Rating Scale 1 and 2.
• Children having molars with active dentin caries score (2,3,4) according to International Caries Detection and Assessment System- ICDAS II, detected by visual and tactile.
• Parents/guardians accept treatment and write informed consent.

Exclusion criteria

• Children with allergy to silver from their medical history.
• Children with ulcerative gingivitis.
• Children with primary molars with the following criteria:
• Symptomatic
• Involving the pulp
• Presence of fistula or sinus
• Presence of gingival inflammation and Pain on percussion
• Close to exfoliation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Arm A: Nano-Silver Fluoride

Experimental group

Description:

Topical application of Nano-Silver Fluoride varnish containing silver nanoparticles, chitosan, and fluoride applied to active dentin caries lesions in primary molars. Application will be performed twice: at baseline and after 6 months, without caries excavation or restoration.

Treatment:

Drug: Nano-Silver Fluoride

Arm B: Silver Diamine Fluoride

Active Comparator group

Description:

Topical application of 38% Silver Diamine Fluoride varnish applied to active dentin caries lesions in primary molars. Application will be performed twice: at baseline and after 6 months, without caries excavation or restoration.

Treatment:

Drug: Silver Diamine Fluoride