Effect Of Silverdiamine Fluoride Gel, Sodium Fluoride With CPP-ACP, APF On Early Childhood Caries - A Randomised Controlled Trial (SDF)

University of Jazan

Status and phase: Active, not recruiting; Phase 2

Conditions: Dental Caries; Early Childhood Caries (ECC)

Treatments: Drug: Silver Diamine Fluoride (SDF, 38%); Drug: Acidulated phospahate fluoride gel 1.23%; Drug: Sodium Fluoride with CPP-ACP

Study type: Interventional

Funder types: Other

Identifiers

NCT07371117

CODJU-21041

Details and patient eligibility

About

Early Childhood Caries (ECC) remains a global public health concern, necessitating minimally invasive, fluoride-based alternatives to conventional restorative therapy. Silver Diamine Fluoride (SDF), Sodium Fluoride with Casein Phosphopeptide-Amorphous Calcium Phosphate (NaF + CPP-ACP), and Acidulated Phosphate Fluoride (APF) gel are widely employed chemotherapeutic agents; however, comparative clinical evidence of their effectiveness in ECC management remains limited.

This randomized controlled clinical trial will evaluate and compare the efficacy of SDF gel, NaF + CPP-ACP, and APF gel in arresting and preventing ECC.

Enrollment: 90 estimated patients

Sex: All

Ages: 2 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The participants who had at least one untreated cavitated active caries lesion with dentin exposed based on the Nyvad criteria (level 3: "Enamel/dentin cavity easily visible with the naked eye where the surface of cavity feels soft or leathery on gentle probing", characterized by dentin exposure without signs of pulp involvement, pain, abscess, sinus tract, or mobility.
• Medically healthy children with no systemic disorders or developmental anomalies

Exclusion criteria

• Parents refused consent for study
• Any child with special health care needs or with any systemic ailments will be excluded from the study
• Teeth exhibiting irreversible pulpitis, abscess, pathological mobility, pathological radiographic changes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

Cavitated/Non cavitated caries lesions involving only enamel

Experimental group

Description:

Reversible pulpitis

Treatment:

Drug: Sodium Fluoride with CPP-ACP

Drug: Acidulated phospahate fluoride gel 1.23%

Drug: Silver Diamine Fluoride (SDF, 38%)

Experimental arm including cavitated/ non cavitated caries lesions involving enamel,dentin but not p

Active Comparator group

Treatment:

Drug: Sodium Fluoride with CPP-ACP

Drug: Acidulated phospahate fluoride gel 1.23%

Drug: Silver Diamine Fluoride (SDF, 38%)