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

• Status: Recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR); New York University School of Medicine; NYU Langone Health; University of Iowa
• Treatments: Fluorides

Criteria

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.