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Search / Trial NCT06797882

Preventive Effects of Silver Diamine Fluoride on Early Enamel Caries

Launched by NATIONAL UNIVERSITY OF MALAYSIA · Jan 27, 2025

Trial Information

Current as of November 05, 2025

Not yet recruiting

Keywords

Early Caries Lesions Silver Diamine Fluoride (Sdf) Fixed Orthodontic Appliances Caries Prevention Fluoride Varnish White Spot Lesions

ClinConnect Summary

This clinical trial is studying the effects of silver diamine fluoride (SDF) on preventing early tooth decay, specifically white spot lesions, in patients undergoing fixed orthodontic treatment with braces. White spot lesions are small, pale areas on teeth that can develop due to demineralization and are often a concern for people with braces. The researchers want to find out if applying SDF around the braces is more effective than traditional fluoride varnish in keeping teeth healthy during treatment.

To participate in this study, you must be at least 18 years old, be about to start fixed orthodontic treatment, and be generally healthy. The trial will include 99 participants, and they will be randomly assigned to one of three groups: one receiving SDF, one receiving fluoride varnish, and one receiving a placebo (a treatment with no active ingredients). Over the course of a year, participants will have their teeth examined several times to check for any changes in the white spots on their teeth. This study aims to provide valuable information that could improve dental care for orthodontic patients in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Subjects about to undergo fixed orthodontic treatment at the Faculty of Dentistry, UKM.
  • Subjects must be aged 18 years and above.
  • Consented for treatment. Patients will be informed of the risk and benefit of the study for each treatment group through the patient information sheet given to them before obtaining their consent.
  • Orthodontic brackets placed at least on the upper incisors.
  • Patients undergoing orthodontic treatment with conventional orthodontic brackets placed on the labial surface.
  • Any degree of malocclusion
  • Fit and healthy patient
  • Non-smoker
  • Subjects can understand and possessed basic command in English
  • Exclusion Criteria:
  • History of fixed orthodontic treatment
  • Presence of any dental anomalies or developmental defects of enamel (DDE) on labial surfaces of teeth, such as preexisting fluorosis or enamel hypoplasia.
  • Presence of any or direct/indirect restorations on the labial surface of teeth
  • History of long-term antibiotic usage
  • Presence of untreated cavitated lesions, especially on upper and lower incisors and canines
  • Plaque levels \>30%.
  • Patient allergic to any of the content of the intervention material (sodium fluoride, silver diamine fluoride, potassium iodide).
  • Patients with lingual brackets.

About National University Of Malaysia

The National University of Malaysia (Universiti Kebangsaan Malaysia, UKM) is a prestigious institution dedicated to advancing medical research and clinical trials that contribute significantly to the fields of healthcare and biomedical sciences. As a leading academic and research university, UKM is committed to fostering innovation and excellence in clinical research, promoting collaboration among multidisciplinary teams, and enhancing the quality of patient care. The university's robust infrastructure and experienced research faculty facilitate rigorous clinical trials aimed at addressing critical health challenges, thereby improving health outcomes both locally and globally. Through its dedication to ethical research practices and adherence to regulatory standards, UKM strives to enhance the understanding of diseases and develop effective interventions that benefit society.

Locations

Kuala Lumpur, Federal Territory Of Kuala Lumpur, Malaysia

Patients applied

0 patients applied

Trial Officials

Ahmad Shuhud Irfani Zakaria, MClinDent

Principal Investigator

National University of Malaysia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported