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Search / Trial NCT05872542

SDF Effectiveness on Arresting Caries in Children

Launched by UMM AL-QURA UNIVERSITY · May 22, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Silver Diamine Fluoride Arrested Caries Deciduous Teeth

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment called silver diamine fluoride (SDF) to help stop tooth decay (dental caries) in young children. Specifically, it aims to see how well SDF works compared to a traditional treatment called glass ionomer restoration, which is typically used to fill cavities. The trial is currently looking for preschool children aged between 1.5 to 5 years who have at least one untreated cavity that isn’t causing any pain. To be part of the study, children need to be generally healthy and not have any serious medical issues that require regular medication.

If your child is eligible and participates in the trial, they will receive either the SDF treatment or the conventional filling, and the researchers will monitor how well each method works in stopping the decay. It’s important to note that children with allergies to silver or certain dental materials, those with specific gum conditions, or those who are not willing to participate cannot join the study. This trial could help improve how we treat tooth decay in young children, so their dental health can be better managed in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Healthy children without a history of serious systemic conditions necessitating chronic use of medications.
  • Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS index: code 3-5) affecting primary molars.
  • Absence of former history of spontaneous pain from the offending tooth/teeth.
  • Teeth with normal vital pulp response when assessed using sensibility test and absence of any signs of irreversible pulpitis or necrotic pulp degeneration.
  • Absence of abnormal grade of tooth mobility, swelling, or tenderness on palpation or percussion.
  • Absence of any evidence of peri-radicular pathosis, or internal- or external resorption on radiographic examination.
  • Exclusion Criteria:
  • Patients with proven allergy to silver compounds or any component of dental materials to be applied.
  • Patients or guardians who refuse to participate in the study or had poor acceptance of SDF treatment.
  • Patients with ulcerative gingivitis or stomatitis.

About Umm Al Qura University

Umm Al-Qura University, located in Mecca, Saudi Arabia, is a prestigious institution dedicated to advancing education and research across various disciplines, including health sciences. As a clinical trial sponsor, the university is committed to fostering innovative research initiatives that contribute to the understanding and treatment of medical conditions. By leveraging its academic resources and expertise, Umm Al-Qura University aims to enhance clinical practices and improve patient outcomes through rigorous scientific investigation and collaboration with healthcare professionals and institutions.

Locations

Mecca, , Saudi Arabia

Patients applied

0 patients applied

Trial Officials

Abla Arafa

Principal Investigator

Assistant Professor

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported