Clinical trial

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

Name

UW 23-064

Description

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.

Trial arms

Trial start

2024-01-01

Estimated PCD

2027-08-31

Trial end

2027-12-31

Status

Recruiting

Phase

Early phase I

Treatment

Silver diamine fluoride gel

Application of 38% SDF gel every 6 months

Arms:

Silver diamine fluoride gel

Other names:

SDF gel

Silver diamine fluoride solution

Application of 38% SDF solution every 6 months

Arms:

Silver diamine fluoride solution

Other names:

SDF solution

Size

630

Primary endpoint

The hardness of cavity on tooth by probing

The follow-up oral examinations will be conducted every 6 months for 30 months totally

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 630, 'type': 'ESTIMATED'}}

Updated at

2024-02-07

1 organization

2 products

1 indication

Organization

The University of Hong Kong

Product

Silver diamine fluoride

Indication

Early Childhood Caries

Product

Silver Diamine Fluoride