Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Cavitated Caries Lesions (NCT03649659) | Clinical Trial Compass
TerminatedPhase 3
Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Cavitated Caries Lesions
Stopped: The trial stopped early due to meeting interim analysis early stopping rules. Active participants at the time of the interim analyses results did complete their remaining study visits. No new participants were enrolled.
United States830 participantsStarted 2018-10-08
Plain-language summary
This trial is a Phase III, multisite, randomized, placebo-controlled trial, with two parallel groups. The groups are SDF or placebo and they are applied every 6 months. The primary hypothesis of the trial is that SDF is better than placebo for stopping cavities with dentin exposed in baby teeth when assessed at 6 months after initial application.
Who can participate
Age range
12 Months – 71 Months
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:
* Child:
* Male or female, between 12-71 months of age at baseline, up to the day the child turns 6 years old.
* Must allow examination of the oral cavity and application of treatment by the examiners at baseline.
* Must have S-ECC \[defined as: In children younger than age 3, any sign (non-cavitated or cavitated lesion) of caries in any tooth surface (i.e., most common for this age group will be on erupted smooth surfaces). From ages 3 through 5, ≥1 dmfs in maxillary anterior teeth; or a dmfs score of ≥4 (age 3), ≥5 (age 4), or ≥6 (age 5) constitutes S-ECC. Note: The "d" component of the dmfs index is defined as including cavitated and non-cavitated lesions, thus ICDAS\>1\].
* Have at least one SDF-target tooth with
* Soft cavitated caries lesions extending into dentin \[ICDAS 5 or 6\];
* Cavitated lesion(s) that allow for direct hardness assessment and application of SDF (microbrush applicator must fit the cavity and be able to access all exposed dentin).
* Parent/Legal Guardian:
* Provide written informed consent for the child and her/himself prior to participation.
* Must be at least 18 years old, or an emancipated minor who provides documentation of emancipation.
* Must be willing and able to participate in trial activities.
Exclusion Criteria:
* Child:
* Hereditary generalized developmental dental defects such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta.
* Known allergy/sensitivity to silver or other heav…
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
The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo