Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Cavitated Caries Lesions

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Cavities of Teeth

In brief

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.

Key facts

Study ID

NCT03649659

Run by

University of Michigan

People needed

830

Starts

2018-10-08

Expected to finish

2023-04-27

Last updated by the study team

2025-01-07

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Iowa College of Dentistry — Iowa City, Iowa, United States
• University of Michigan School of Dentistry — Ann Arbor, Michigan, United States
• New York University College of Dentistry — New York, New York, United States

Full record on ClinicalTrials.gov

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