Clinical trial NCT02601833: Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques
Official title: The Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques: A 12 Month Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Caries
Keywords: Caries
Cavity
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Mott Children's Health Center
First posted: 2015-11-10
Enrollment: 98
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Caries Arrest of Teeth in the SDF Group Measured by Change in Size
timeFrame: 12 Months
measure: Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black)
timeFrame: 12 Months
measure: Caries Arrest of Teeth in the SDF Group Measured by Dentin Texture (Soft, Hard)
timeFrame: 12 Months
measure: Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair)
timeFrame: 12 Months
measure: Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess)
timeFrame: 12 Months
Secondary outcomes:
measure: Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less)
timeFrame: Baseline
measure: Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty)
timeFrame: Baseline
measure: Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable)
timeFrame: Baseline
measure: Parent Assessment of Appearance of Child's Teeth
timeFrame: 12 Months
measure: Parent Assessment of Treatment Provided
timeFrame: 12 Months
measure: Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad)
timeFrame: 12 Months
measure: Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot)
timeFrame: 12 Months
measure: Costs of Treatment (Dollars)
timeFrame: Baseline
measure: Time of Treatment Procedures (Duration of Time in Minutes)
timeFrame: Baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
city: Flint
country: United States
facility: Mott Children's Health Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Margherita R Fontana, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cleary J, Al-Hadidi R, Scully A, Yahn W, Zaid Z, Boynton JR, Eckert GJ, Yanca E, Fontana M. A 12-Month Randomized Clinical Trial of 38% SDF vs. Restorative Treatment. JDR Clin Trans Res. 2022 Apr;7(2):135-144. doi: 10.1177/23800844211072741. Epub 2022 Feb 4.