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Comparing the Effectiveness of Papain Based Chemico-mechanical Caries Removal Gel and 38% Silver Diamine Fluoride for Treating Active Caries Lesion of Primary Molars

NCT06412731 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-05-08

No results posted yet for this study

Summary

This study aims to investigate the efficacy of silver diamine fluoride (SDF) and Papain-based chemico-mechanical caries removal gel and using ceramic bur as a control in treating dentine caries in primary molars aged 7-8 years children. by investigating the following outcomes:

1. Arrestment of caries lesion and the emergence of a new one
2. Time required for the treatment
3. Adverse events
4. Children's anxiety

Conditions

  • Dental Caries in Children

Interventions

OTHER

Cera-bur

Dental caries removal using a low-speed handpiece and a ceramic bur and restoring the cavity with Glass ionomer filling material

OTHER

Brix3000

Chemical-dissolving active dental caries and hand instrument used for removing the lesion then restoring with Glass ionomer filling material

OTHER

E-SDF

Arresting the infected dentin and the demineralized lesion covered with Glass-ionomer filling

Sponsors & Collaborators

  • Al-Mustansiriyah University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2024-05-23
Completion
2024-07-01

Countries

  • Iraq

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 NCT06412731 on ClinicalTrials.gov