Trials / Completed
CompletedNCT02601833
Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques
The Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques: A 12 Month Randomized Controlled Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 98 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 2 Years – 10 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Silver Diamine Fluoride | No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet. |
| PROCEDURE | Conventional Caries Management | These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic. 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. |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2020-09-18
- Completion
- 2020-09-18
- First posted
- 2015-11-10
- Last updated
- 2021-11-22
- Results posted
- 2021-11-22
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02601833. Inclusion in this directory is not an endorsement.