Silver Diamine Fluoride(SDF) Versus SDF Combined With Sodium Fluoride Varnish in the Arrest of Ea… (NCT05642494) | Clinical Trial Compass
CompletedPhase 3
Silver Diamine Fluoride(SDF) Versus SDF Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries
Egypt220 participantsStarted 2022-03-01
Plain-language summary
Early childhood caries (ECC) is the most common chronic childhood disease worldwide. Early restorative intervention may treat the disease but this is often difficult especially with uncooperative children so it may be left untreated. Remineralization of affected dentin using silver diamine fluoride (SDF) can arrest these lesions.
This trial aims to compare the effectiveness of 38% SDF solution versus 38% SDF solution with 5% sodium fluoride (NaF) varnish after six months in arresting ECC lesions.
Who can participate
Age range
1 Year – 4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Children ≤ 4 years old.
. The presence of at least one carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II, Appendix 1, Table 1), detected by visual examination.
. The Carious lesion has to be active according to Lesion Activity criteria of coronal caries of ICDAS II.
. Parental consent for children's participation in the study.
Exclusion criteria
. Children reporting spontaneous or elicited pain from caries, or showing any signs of pulpal infection, swelling and/or abscess.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.