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Silver Diamine Fluoride: A Randomized Controlled Trial on Its Effectiveness As A Caries Arresting Agent

NCT05008718 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2023-11-18

No results posted yet for this study

Summary

The aim of the study is to assess the effectiveness of 38% Silver Diamine Fluoride (SDF) solution and to determine if it is superior to 5% NaF varnish in arresting carious lesions in the primary teeth of young children attending general dental clinic, Universiti Teknologi Mara.

Hypothesis: Topical application of a 38% SDF solution on the primary teeth is superior to that of a 5% NaF varnish in arresting caries lesions in children at 3-months follow-up

An intervention study is planned to compare the effectiveness of 38% SDF and 5% NaF in arresting caries lesions in primary teeth of 3-8 years old children attending general dental clinic, Universiti Teknologi Mara. The sample size needed (considering a 20% dropout rate) is 66 participants in each group. In addition, this study also aims to determine the demographic background, oral health-related habits, oral health-related quality of life of the participants and the parents acceptance on SDF treatment towards their child.

Conditions

  • Dental Caries
  • Quality of Life

Interventions

OTHER

38% SDF group

Participants will be randomized and will receive either 38% SDF treatment or 5% NaF treatment

OTHER

5% NaF group

Participants will be randomized and will receive either 38% SDF treatment or 5% NaF treatment

Sponsors & Collaborators

  • Universiti Teknologi Mara

    lead OTHER

Principal Investigators

  • Intan Elliayana binti Mohammed · Faculty of Dentistry, Universiti Teknologi Mara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-06-21
Primary Completion
2023-02-10
Completion
2024-02-29

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 NCT05008718 on ClinicalTrials.gov