Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques

University of Michigan

Status and phase: Completed; Phase 3

Conditions: Caries

Treatments: Device: Silver Diamine Fluoride; Procedure: Conventional Caries Management

Study type: Interventional

Funder types: Other

Identifiers

NCT02601833

HUM00097829

Details and patient eligibility

About

The purpose of this study is to compare standard fillings and silver diamine fluoride (SDF) for treatment of cavities in baby teeth. The investigators will compare the effectiveness of stopping the cavity, cost of the treatments and the opinions of the families and the dental providers.

Full description

To determine the effectiveness of the application of silver diamine fluoride (SDF) in comparison to conventional restorative treatments in International Caries Detection and Assessment System criteria (ICDAS) 5 and 6, one and two surface carious lesions in primary molars which will be assessed based on major and minor failure criteria when followed for one year. Additionally, parents'/children's and providers' perceptions will be assessed as well as the cost of both regimens, to include both chair time spent and materials' costs.

Enrollment: 98 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of at least one active (soft) cavitated carious lesions in the primary dentition, extending into dentin (ICDAS 5 or 6)
• The selected tooth must have a one or two surface lesion (more than 1/3 of the crown of the tooth must be remaining) and must allow for direct application of SDF
• Study teeth will not have any spontaneous or elicited pain due to caries, tooth mobility, or signs of pulpal infection
• Selected primary teeth must have an anticipated exfoliation date greater than 12 months away

Exclusion criteria

• Hereditary developmental defects such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
• Severe medical conditions that do not allow the child to be managed in the clinic
• Known allergy /sensitivity to dental materials being used, including SDF
• Inability of the child to cooperate for treatment, recall examinations, or periapical radiographs
• Wards of the State, for consenting reasons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Silver Diamine Fluoride

Experimental group

Description:

This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries.

Treatment:

Device: Silver Diamine Fluoride

Conventional Caries Management

Active Comparator group

Description:

Restorative dental care according to American Academy of Pediatric Dentistry guidelines. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.

Treatment:

Procedure: Conventional Caries Management