Effectiveness of Silver Diamine Fluoride as a Treatment for Caries in Comparison to Traditional Restorative Techniques
NCT ID: NCT02601833
Last Updated: 2021-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
98 participants
INTERVENTIONAL
2016-01-31
2020-09-18
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
10 Years
ALL
No
Sponsors
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Mott Children's Health Center
OTHER
University of Michigan
OTHER
Responsible Party
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Margherita Fontana
Professor
Principal Investigators
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Margherita R Fontana, DDS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan School of Dentistry
Ann Arbor, Michigan, United States
Mott Children's Health Center
Flint, Michigan, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HUM00097829
Identifier Type: -
Identifier Source: org_study_id