Arresting Early Childhood Caries With a Silver Diamine Fluoride Gel
- Conditions
- Early Childhood Caries
- Interventions
- Registration Number
- NCT06241261
- Lead Sponsor
- The University of Hong Kong
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 630
- generally healthy, have at least one tooth with cavitated dentine carious lesion
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Silver diamine fluoride solution Silver diamine fluoride solution 38% silver diamine fluoride solution Silver diamine fluoride gel Silver diamine fluoride gel 38% silver diamine fluoride gel
- Primary Outcome Measures
Name Time Method The hardness of cavity on tooth by probing The follow-up oral examinations will be conducted every 6 months for 30 months totally The number of active carious tooth surfaces that become arrested per child
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The University of Hong Kong
🇨🇳Hong Kong, China