Using silver diamine fluoride gel to treat early childhood cavities
Randomised Clinical Trial to Arrest Early Childhood Caries With a Silver Diamine Fluoride Gel
PHASE2 · The University of Hong Kong · NCT06241261
This study is testing if a gel form of silver diamine fluoride can help stop cavities in preschool children better than the traditional liquid version.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 630 (estimated) |
| Ages | 3 Years to 5 Years |
| Sex | All |
| Sponsor | The University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06241261 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a 38% silver diamine fluoride (SDF) gel compared to a traditional 38% SDF solution in arresting carious lesions in preschool children. The study will involve 630 children aged 3 to 4 years, who will receive either treatment every six months over a 30-month period. The primary outcome will be the proportion of active carious tooth surfaces that show arrest at the 30-month follow-up, with all participants and examiners blinded to the treatment received. The trial will also collect data on children's oral health behaviors and socioeconomic backgrounds to assess any potential effects on outcomes.
Who should consider this trial
Good fit: Ideal candidates are generally healthy preschool children aged 3 to 4 years with at least one tooth exhibiting a cavitated dentine carious lesion.
Not a fit: Patients who are uncooperative, have severe oral diseases, or are undergoing other dental treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a cost-effective and non-invasive method for managing early childhood caries.
How similar studies have performed: Previous studies have shown promise with silver diamine fluoride solutions, but the gel formulation is novel and has not been clinically tested before.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- The University of Hong Kong — Hong Kong, China (RECRUITING)
Study contacts
- Principal investigator: Chun Hung Chu, Ph.D — The University of Hong Kong
- Study coordinator: Chun Hung Chu, Ph.D
- Email: chchu@hku.hk
- Phone: (+852)28590287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Early Childhood Caries, Silver Diamine Fluoride, Caries, Arrest, Gel, Children