Skip to main content
OpenTrials
Completed

NCT Number: NCT05655286

Effectiveness of SDF With Different Post-treatment Protocols in Arresting Dental Caries

To compare the effectiveness of the semi-annual application of 38% SDF with two post-treatment protocols in arresting dental caries in preschool children

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The university of Hong Kong

Hong Kong, China

About this study

Methods: The randomized clinical trial will recruit 254 healthy kindergarten children aged 3-4 years old with caries and with parental consent. All the tooth surfaces with carious lesions will receive the semi-annual application of 38% SDF solution. After the treatment, children will be allocated to two groups by an independent research assistant. Two post-treatment protocols are as follows.

Group A - Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children.

Group B - Children are instructed not to eat and drink for at least 30 minutes. Clinical examinations after 6-months will be conducted to assess whether the caries is arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 12-months follow-up. The analysis will determine the significance of differences between the percentage of arrested caries at the various follow-ups.

Significance: This study will help determine the optimal post-op treatment in SDF treatment. The study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 3-5 year old children attending the first to the third year of kindergarten;
  • free from any systemic conditions and generally healthy;
  • parents sign informed consent;
  • having at least 1 tooth with cavitated dentine carious lesion

Exclusion criteria

  • are uncooperative to accept oral examination or treatment;
  • have a significant systematic disease or long-term medications;
  • have abnormal dentition.
  • Teeth having signs or symptoms of irreversible pulpitis and non-vitality will be excluded.

Treatment and study plan

38% SDF treatment

Drug

Children with active caries will receive 38% silver diamine fluoride treatment

not to rinse for at least 30 minutes after SDF treatment

Behavioral

After receiving 38% silver diamine fluoride treatment, Children will be asked not to rinse their mouths for at least 30 minutes.

rinse mouth immediately after SDF treatment

Behavioral

After receiving 38% silver diamine fluoride treatment, Children will be asked to rinse their mouths immediately.

Primary outcomes

  1. Caries status

    Time frame: at 12-month follow-up

    The proportion of the soft (active) carious tooth lesion surfaces that harden (arrested) at 12 months of follow-up will be measured

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

The Effectiveness of Silver Diamine Fluoride Treatment With Different Post-treatment Protocols in Arresting Dental Caries in Primary Teeth of Preschool Children

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2022
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.