Status:

UNKNOWN

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

Lead Sponsor:

University of Malaya

Conditions:

Dental Caries in Children

Eligibility:

All Genders

4-10 years

Phase:

NA

Brief 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 ...

Detailed Description

This research aims to determine the pharmacokinetics characteristics of silver and fluoride following topical application of Silver Diamine Fluoride (SDF) in healthy children. The use of Silver Diamin...

Eligibility Criteria

Inclusion

  • 1\. Healthy children aged between 4 to 10 years old
  • With at least one decayed primary tooth without clinical signs or symptoms suggesting reversible or irreversible pulpitis.
  • Radiographically the deepest layer of caries lesion does not encroach on pulp, and inter-radicular supporting structures appear normal

Exclusion

  • Children aged below 4 years and above 10 years
  • Healthy children aged between 4 to 10 years old
  • Do not have decayed teeth
  • The decayed tooth with clinical signs or symptoms suggesting reversible or irreversible pulpitis
  • Radiographically the deepest layer of caries lesion does encroach on pulp, and inter-radicular supporting structures appear abnormal
  • No consent and permission to join the study
  • Taking medications/over the counter medications/supplements
  • Known allergy to silver or fluoride
  • Presence of ulcer in the mouth which has not heal completely
  • Presence of at least one tooth treated with silver fillings or stainless steel crown.
  • Presence of at least one tooth filled with a material that contains glass particles known as glass ionomer within a year before this research.
  • Children with medical problems

Key Trial Info

Start Date :

July 3 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 26 2021

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT04766775

Start Date

July 3 2020

End Date

November 26 2021

Last Update

March 3 2021

Active Locations (1)

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1

University of Malaya

Kuala Lumpur, Kuala, Malaysia, 50603