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

NCT03649659 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: HUM00147622U01DE027372
• Study Type: interventional
• Target: 830
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cavities of Teeth

Outcome Measures

Primary Outcomes (1)

• The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo

  Arrested trial lesions will be assessed by determining if the lesion is hard or soft by pressing on the lesion using a standard probe as assessed by calibrated examiners.

  6 months

Secondary Outcomes (3)

• The Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After Two Treatments With SDF or Placebo

  8 months

• Proportion of Arrested Trial Lesions Per Child in Each Treatment Arm After One Treatment With SDF or Placebo

  3 months

• Proportion of Trial Lesions With Pain Prior to or at the 8-month Visit

  Baseline, 24-48 hour call, 1.5 month, 3 month, 4.5 month, 6 month, 24-48 hours after 6 month, 7 month, 8 month

Study Arms (2)

Silver Diamine Fluoride (SDF)

EXPERIMENTAL

SDF will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.

Drug: Silver Diamine Fluoride

Placebo

PLACEBO COMPARATOR

The placebo will be applied to the affected teeth twice during the study. Once at screening/baseline and again at the 6-month visit.

Drug: Placebo

Interventions

Silver Diamine Fluoride DRUG

SDF will be applied twice during the study

Also known as: Diammine Silver Fluoride

Silver Diamine Fluoride (SDF)

Placebo DRUG

This is being compared to the SDF and will also be applied twice

Placebo

Eligibility Criteria

• Age: 12 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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).
• 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).

Sponsors & Collaborators

• University of Michigan: lead
• NYU Langone Health: collaborator
• University of Iowa: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (3)

University of Iowa College of Dentistry

Iowa City, Iowa, 52242, United States

Location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

New York University College of Dentistry

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

silver diamine fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Limitations and Caveats

The trial was stopped early due to efficacy after the interim analysis. All subjects enrolled when the early termination was decided were allowed to finish the trial and their data were included in the analyses.

Results Point of Contact

• Title: Dr. Margherita Fontana
• Organization: University of Michigan

mfontan@umich.edu

734-763-3988

Study Officials

• Margherita Fontana, DDS, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 28, 2018
• Study Start: October 8, 2018
• Primary Completion: April 11, 2023
• Study Completion: April 27, 2023
• Last Updated: January 7, 2025
• Results First Posted: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)