Status:
COMPLETED
Treatment of Interproximal Cavities on Primary Molar Teeth With Silver Diamine Fluoride
Lead Sponsor:
Children's Hospital Los Angeles
Collaborating Sponsors:
University of Southern California
Conditions:
Dental Caries in Children
Dental Caries Class II
Eligibility:
All Genders
3-12 years
Phase:
NA
Brief Summary
This study investigates whether 1) Silver diamine fluoride (SDF) application using Super Floss can arrest and/or reverse initial interproximal caries on primary molars and 2) whether SDF applied with ...
Detailed Description
Interproximal carious lesions are challenging to control and arrest due to difficulty reaching the contact area (in between teeth), limited salivary access, and poor flossing compliance in children an...
Eligibility Criteria
Inclusion
- ASA I and ASA II children, aged 3-12
- Behavior of 3 or 4 on Frankl scale
- Radiographic decay within enamel or extending to the dentin-enamel junction based on International Caries Classification and Management System (ICCMS) Categories 1, 2 and 3 "Initial stages".
- Target interproximal lesion does not have existing restoration, recurrent decay, or adjacent teeth with existing restorations.
Exclusion
- Children who are not ASA I or ASA II
- Children who are allergic to or intolerant of SDF
- Children who have known sensitivity to silver or heavy metal-ions, or have abnormal skin sensitization.
- Children who have ulcerative gingivitis or stomatitis.
- Carious interproximal lesions on primary molars in ICCMS Category 4, 5, or 6 18 , which signify the extent of the carious lesion radiographically reaching the middle 1/3 of dentin, inner 1/3 of dentin, and into the pulp respectively.
- Behavior of a child within the Frankl 1 or 2 category, indicating a "Definitely Negative" and "Negative" behavior, which may compromise safe application of SDF.
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03770286
Start Date
January 22 2019
End Date
May 31 2023
Last Update
October 15 2024
Active Locations (1)
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1
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027