Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques
- Conditions
- Caries
- Interventions
- Device: Silver Diamine FluorideProcedure: Conventional Caries Management
- Registration Number
- NCT02601833
- Lead Sponsor
- University of Michigan
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Silver Diamine Fluoride Silver Diamine Fluoride This arm will receive Silver Diamine Fluoride applied to their carious lesion, in lieu of restoration placement, with the goal of arresting caries. Conventional Caries Management Conventional Caries Management 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.
- Primary Outcome Measures
Name Time Method Caries Arrest of Teeth in the SDF Group Measured by Dentin Color (Yellow, Brown, Black) 12 Months Color of the cavity at the end of the trial
Signs of Pulpal Pathology (Lesion Reaching the Pulp Requiring Pulpular Treatment-pulpotomy and/or Pulpectomy-, Reversible Pulpitis, Irreversible Pulpitis, Abscess) 12 Months Signs of pulpal pathology are treatment failures. Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment.
Caries Arrest of Teeth in the SDF Group Measured by Change in Size 12 Months Number of participants in the SDF arm that had an increase in lesion size at any point in the 12 months of the trial, as this is a treatment failure.
Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were then removed from the trial for further clinical treatment.Restoration Integrity for Teeth in Control Group (Secondary Caries, Lost Restoration, Restoration Needing Repair) 12 Months Secondary caries, lost restorations, or restorations needing repair are treatment failures.
Treatment failures were assessed throughout the 12 month duration of the trial, and children with treatment failures were removed from the trial for further clinical treatment.Caries Arrest of Teeth in the SDF Group Measured by Dentin Texture (Soft, Hard) 12 Months Texture of the cavity's dentin of soft means the cavity is still an active infection. If the cavity is hard, the cavity is no longer an active infection (has been arrested).
Please note dentin texture cannot be assessed for the Conventional group as the dentin is no longer accessible following baseline treatment.
- Secondary Outcome Measures
Name Time Method Number of Providers Who Find Treatment With SDF More Favorable in Preference of Treatment Modality (More Preferable, no Preference, Less Preferable) Baseline Costs of Treatment (Dollars) Baseline Cost of one application of SDF and one 1-2 surface conventional restoration. Cost was calculated by taking the average Medicaid reimbursement across all U.S. states.
Number of Providers Who Find Treatment With SDF More Favorable in Time for Treatment (More, Same, Less) Baseline Data collected at baseline only.
Time of Treatment Procedures (Duration of Time in Minutes) Baseline Parent Assessment of Appearance of Child's Teeth 12 Months Parents were asked "Are you concerned with the appearance of your child's teeth?"
Parent Assessment of Treatment Provided 12 Months Parents were asked "If your child had another cavity, would you be willing to have that tooth treated with the same treatment option provided to your child in this study?"
Child Assessment of Experience During Dental Visit (Didn't Hurt, Hurt a Little, Hurt a Lot) 12 Months Number of Providers Who Find Treatment With SDF More Favorable in Ease of Treatment (Easier, Harder, Same Difficulty) Baseline Child Assessment of Appearance of Teeth (Very Happy, Not Happy or Sad, Very Sad) 12 Months
Trial Locations
- Locations (2)
Mott Children's Health Center
🇺🇸Flint, Michigan, United States
University of Michigan School of Dentistry
🇺🇸Ann Arbor, Michigan, United States