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SDF Effectiveness on Arresting Caries in Children

NCT05872542 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-04

No results posted yet for this study

Summary

Purpose: To assess the clinical effectiveness of silver diamine fluoride (SDF) to control asymptomatic cavitated carious lesions compared to conventional glass ionomer restoration in preschool children.

Conditions

  • Dental Caries in Children

Interventions

DRUG

Silver Diamine Fluoride (SDF)

Proper isolation of the operating field and removal of gross debris. Minimize contact with the gingiva and mucus membrane. Gentle dryness with compressed air. Dip and dab micro brush on the side of the dapper dish. Apply SDF to the affected surface (one drop/ appointment). Gentle dryness with compressed air for one minute. Remove excess SDF with gauze or cotton pellets. Continue to isolate the site for up to three minutes.

OTHER

Glass Ionomer Restoration (GI)

Application of GI restoration necessitates removal of carious tissue using round bur rotating on low-speed contra and excavation of infected carious dentin. Followed by restoring the prepared cavity with glass ionomer restoration according to the manufacturer's instructions. The restoration will be checked for any high spots and occlusal interference (if any) will be corrected.

OTHER

Sodium fluoride varnish with nano-sliver particles (NaF-AgNP)

Proper isolation of the operating field and removal of gross debris. Minimize contact with the gingiva and mucus membrane. Gentle dryness with compressed air. Dip and dab micro brush on the side of the dapper dish. Apply NaF-AGNP to the affected surface (one drop/ appointment). Gentle dryness with compressed air for one minute. Continue to isolate the site for up to three minutes.

Sponsors & Collaborators

  • Umm Al-Qura University

    lead OTHER

Principal Investigators

  • Abla Arafa · Assistant Professor

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-12-31
Completion
2024-06-30
FDA Drug
Yes

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05872542 on ClinicalTrials.gov