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

This is an interventional treatment trial for Cavities of Teeth Read More

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.