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A simple silver liquid may halt cavities in Toddlers—Without drilling

NCT ID NCT03649659

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

830 people

The number who actually took part.

Started

Oct 2018

Finished

Apr 2023

Lead sponsor

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

12 to 71 months

Sex

Anyone

Healthy volunteers

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

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

  • New York University College of Dentistry

    New York, New York, 10010, United States

  • University of Iowa College of Dentistry

    Iowa City, Iowa, 52242, United States

  • University of Michigan School of Dentistry

    Ann Arbor, Michigan, 48109, United States

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