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The Pharmacokinetics of Silver Diamine Fluoride (SDF) in Healthy Children

NCT04766775 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-03-03

No results posted yet for this study

Summary

This study focus on the pharmacokinetic characteristic of silver diamine fluoride (SDF) in healthy children. All of the children received treatment for the decayed teeth in the same way. A medication called silver diamine fluoride is used to treat the decayed teeth. It contains a high concentration of fluoride (range from 14100 ppm to 51013 ppm) and silver. This medication halts the decay process through the combined effects of anti-bacterial from silver and remineralization from fluoride. As this product contains the highest concentration of fluoride level found in the market and the metal element of silver, the investigators aim to study the body's reaction towards SDF. The investigators collect the hair and urine samples at different time points and then analyze them to determine the silver and/or fluoride levels. The outcomes include 1. the silver level in the hair and urine samples 2. the fluoride level in the urine samples. The investigators analyze the silver level in hair and urine samples using Inductively Coupled Plasma Mass Spectrometry (ICP-MS); fluoride level in urine samples using Ion-Selective Electrode.

Conditions

  • Dental Caries in Children

Interventions

DEVICE

Silver Diamine Fluoride

Silver Diamine Fluoride (Riva Star) which contains silver, fluoride, ammonia and water.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Siau Peng Lim, DDS (USM) · University of Malaya, Faculty of Dentistry

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-03
Primary Completion
2020-11-26
Completion
2021-11-26

Countries

  • Malaysia

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 NCT04766775 on ClinicalTrials.gov