Arresting Early Childhood Caries With a Silver Diamine Fluoride Gel

NCT06241261 | Active Not Recruiting Phase 2

• 1 other identifier: UW 23-064
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Childhood Caries

Keywords

Silver Diamine Fluoride; Caries; Arrest; Gel; Children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Silver diamine fluoride gel

EXPERIMENTAL

38% silver diamine fluoride gel

Drug: Silver diamine fluoride gel

Silver diamine fluoride solution

ACTIVE COMPARATOR

38% silver diamine fluoride solution

Drug: Silver diamine fluoride solution

Interventions

Silver diamine fluoride gel DRUG

Application of 38% SDF gel every 6 months

Also known as: SDF gel

Silver diamine fluoride gel

Silver diamine fluoride solution DRUG

Application of 38% SDF solution every 6 months

Also known as: SDF solution

Silver diamine fluoride solution

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

Related Publications (1)

• Cheng AY, Chen J, Zheng FM, Duangthip D, Chu CH. Arresting Early Childhood Caries with Silver Diamine Fluoride Gel Among Preschool Children: Protocol for a Randomised Clinical Trial. Dent J (Basel). 2024 Dec 22;12(12):419. doi: 10.3390/dj12120419.

  PMID: 39727476 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Chun Hung Chu, Ph.D

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)