Arresting Early Childhood Caries With a Silver Diamine Fluoride Gel

Early Childhood Caries Clinical Trial

Official title:

Randomised Clinical Trial to Arrest Early Childhood Caries With a Silver Diamine Fluoride Gel

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241261
• Other study ID #: UW 23-064
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: The University of Hong Kong
• Contact: Chun Hung Chu, Ph.D
• Phone: (+852)28590287
• Email: chchu[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 630
• Est. completion date: December 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

Inclusion Criteria:

• generally healthy, have at least one tooth with cavitated dentine carious lesion

Exclusion Criteria:

• uncooperative and difficult to manage, with severe forms of hypoplasia of fluorosis or other oral diseases, wearing orthodontic devices or under dental treatment, have major systemic diseases, or are on long-term medication

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

Drug:
• Silver diamine fluoride gel
Application of 38% SDF gel every 6 months
• Silver diamine fluoride solution
Application of 38% SDF solution every 6 months

Locations

Country	Name	City	State
China	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The hardness of cavity on tooth by probing	The number of active carious tooth surfaces that become arrested per child	The follow-up oral examinations will be conducted every 6 months for 30 months totally