Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-29 @ 2:22 AM
Study NCT ID:
NCT06241261
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2024-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arresting Early Childhood Caries With a Silver Diamine Fluoride Gel
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
Randomised Clinical Trial to Arrest Early Childhood Caries With a Silver Diamine Fluoride Gel
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to determine whether the efficacy of a 38% silver diamine fluoride (SDF) gel is non-inferior to a 38% SDF solution for arresting carious lesions in preschool children when applied at half-yearly intervals over a 30-month period.
Detailed Description:
Aim: Silver diamine fluoride (SDF) is typically available as a 38% aqueous solution, which is runny and difficult to apply. A 38% SDF gel has been introduced but it has not been tested clinically. The objective is to determine whether the efficacy of a 38% SDF gel is non-inferior to a 38% SDF solution for arresting carious lesions in preschool children.
Methods / Design: This non-inferiority randomised clinical trial will recruit 630 3- to 4-year-old children to receive either SDF gel or SDF solution on their carious lesions every 6 months. The primary outcome is the proportion of active carious tooth surfaces that arrest at the 30-month follow-up. The same examiner will conduct all examinations at the kindergartens over 30 months. The examiner, the children, and the children's parents will be blinded to treatments. The parents will be surveyed on their child's oral health-related behaviours and socioeconomic background to allow adjustment for effect modification.
Significance: If the result is as anticipated, SDF gel will prolong contact of SDF with the carious lesion to promote remineralisation. As SDF gel is cost-effective, simple, non-invasive, and non-aerosol-generating, it can be widely recommended for caries control.
Methods / Design: This non-inferiority randomised clinical trial will recruit 630 3- to 4-year-old children to receive either SDF gel or SDF solution on their carious lesions every 6 months. The primary outcome is the proportion of active carious tooth surfaces that arrest at the 30-month follow-up. The same examiner will conduct all examinations at the kindergartens over 30 months. The examiner, the children, and the children's parents will be blinded to treatments. The parents will be surveyed on their child's oral health-related behaviours and socioeconomic background to allow adjustment for effect modification.
Significance: If the result is as anticipated, SDF gel will prolong contact of SDF with the carious lesion to promote remineralisation. As SDF gel is cost-effective, simple, non-invasive, and non-aerosol-generating, it can be widely recommended for caries control.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: