A simple silver liquid may halt cavities in Toddlers—Without drilling
NCT ID NCT03649659
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial tests whether a liquid called silver diamine fluoride (SDF) can stop cavities in baby teeth. About 830 children aged 12 months to 5 years with active cavities will receive either SDF or a placebo applied to their teeth twice, six months apart. Researchers will check if the cavities become hard (arrested) after each treatment. The goal is to see if SDF is a better option than doing nothing to stop tooth decay in young children.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Silver diamine fluoride (SDF), a liquid applied to teeth to stop cavities
- What this could lead to
- If it works, this could offer a simple, non-invasive way to stop cavities in baby teeth, potentially reducing the need for drilling or fillings in young children.
- What could go wrong
- This is a Phase III trial, but results are not yet known. The treatment may not be more effective than placebo, and there could be side effects like tooth staining or temporary taste changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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830 people
The number who actually took part.
- Started
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Oct 2018
- Finished
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Apr 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 71 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 heavy metal ions. * Presence of any gingival or peri-oral ulceration, abscess or stomatitis. * Participating in the foster care system at trial initiation. * Toothache pain at baseline (based on Dental Discomfort Questionnaire score of 1 or higher). * Note: If toothache pain occurs after baseline, the child remains eligible to continue in the trial as long as he/she has at least one trial tooth that meets tooth inclusion/exclusion criteria. * Demonstrated inability to comply with trial protocol requirements (determination is at the Clinical Site Investigator's discretion). * Rickets. * Osteopenia or osteoporosis (e.g., Osteogenesis Imperfecta, Ehlers-Danlos Syndrome, Marfan Syndrome, etc.). * Chronic diseases such as chronic kidney disease, leukemia, lymphoma, rheumatic disorders, etc. * Metabolic bone disease (e.g., Galactosemia, Glycogen Storage Disease Type 1, etc.). * Chronic glucocorticoid, anticonvulsants, chemotherapy, bisphosphonate administration. * Hypothyroidism, hyperparathyroidism, impaired glucose tolerance, hypocalcemia or hypophosphatemia. * Tooth: * Pain due to caries (based on DDQ score of 1 or higher). * Note: If toothache pain occurs after baseline, the tooth is removed from the study. * Pulpal exposure, or signs of pulpal infection (abscess, fistula, swelling). * Mobility not associated with expected exfoliation patterns. * Parent/Legal Guardian: * Demonstrated inability to comply with trial protocol requirements (determination is at the Clinical Site Investigator's discretion). * Inability to read and comprehend the consent document or trial questionnaires in the translated languages available.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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New York University College of Dentistry
New York, New York, 10010, United States
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University of Iowa College of Dentistry
Iowa City, Iowa, 52242, United States
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University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109, United States
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