N/A
N=51
Treatment of Interproximal Cavities on Primary Molar Teeth With Silver Diamine Fluoride
Dental Caries in Children · Dental Caries Class II · Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT03770286 ↗Enrolled (actual)
51
Serious AEs
—
Results posted
Oct 2024
Primary outcome: Primary: Interproximal Caries Zone of Radiolucency — 9; 7; 10; 12 Number of teeth
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 5% Fluoride Varnish (Device); 38% Silver diamine fluoride (Device); Super Floss (Device)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Los Angeles
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Interproximal Caries Zone of Radiolucency |
8; 8; 10; 10; 20; 13 | — |
| PRIMARY Interproximal Caries Zone of Radiolucency |
8; 8; 10; 10; 20; 13 | — |
| PRIMARY Interproximal Caries Zone of Radiolucency |
8; 8; 10; 10; 20; 13 | — |
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 Super Floss is more effective in arresting or remineralizing initial interproximal lesion in comparison to SDF applied without Super Floss or fluoride varnish applied alone.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03770286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.