Effect Of Silverdiamine Fluoride Gel, Sodium Fluoride With CPP-ACP, APF On Early Childhood Caries… (NCT07371117) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Effect Of Silverdiamine Fluoride Gel, Sodium Fluoride With CPP-ACP, APF On Early Childhood Caries - A Randomised Controlled Trial
Saudi Arabia90 participantsStarted 2025-11-01
Plain-language summary
Early Childhood Caries (ECC) remains a global public health concern, necessitating minimally invasive, fluoride-based alternatives to conventional restorative therapy. Silver Diamine Fluoride (SDF), Sodium Fluoride with Casein Phosphopeptide-Amorphous Calcium Phosphate (NaF + CPP-ACP), and Acidulated Phosphate Fluoride (APF) gel are widely employed chemotherapeutic agents; however, comparative clinical evidence of their effectiveness in ECC management remains limited.
This randomized controlled clinical trial will evaluate and compare the efficacy of SDF gel, NaF + CPP-ACP, and APF gel in arresting and preventing ECC.
Who can participate
Age range
2 Years – 9 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:
* The participants who had at least one untreated cavitated active caries lesion with dentin exposed based on the Nyvad criteria (level 3: "Enamel/dentin cavity easily visible with the naked eye where the surface of cavity feels soft or leathery on gentle probing", characterized by dentin exposure without signs of pulp involvement, pain, abscess, sinus tract, or mobility.
* Medically healthy children with no systemic disorders or developmental anomalies
Exclusion Criteria:
* Parents refused consent for study
* Any child with special health care needs or with any systemic ailments will be excluded from the study
* Teeth exhibiting irreversible pulpitis, abscess, pathological mobility, pathological radiographic changes
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.
What they're measuring
1
Dental caries arrest
Timeframe: Caries arrest will be assessed 6 months after intervention