Dental Caries Clinical Trial
Official title:
Treatment of Interproximal Carious Lesions on Primary Molar Teeth With SDF and Super Floss Application Versus SDF Without Super Floss Versus Fluoride Varnish Alone: a Pilot Phase 3 Randomized Controlled Trial
Verified date | June 2024 |
Source | Children's Hospital Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | May 31, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 12 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Childrens Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles | University of Southern California |
United States,
Hammersmith KJ, DePalo JR, Casamassimo PS, MacLean JK, Peng J. Silver Diamine Fluoride and Fluoride Varnish May Halt Interproximal Caries Progression in the Primary Dentition. J Clin Pediatr Dent. 2020;44(2):79-83. doi: 10.17796/1053-4625-44.2.2. — View Citation
Horst JA, Ellenikiotis H, Milgrom PL. UCSF Protocol for Caries Arrest Using Silver Diamine Fluoride: Rationale, Indications and Consent. J Calif Dent Assoc. 2016 Jan;44(1):16-28. — View Citation
Rosenblatt A, Stamford TC, Niederman R. Silver diamine fluoride: a caries "silver-fluoride bullet". J Dent Res. 2009 Feb;88(2):116-25. doi: 10.1177/0022034508329406. — View Citation
Schwendicke F, Meyer-Lueckel H, Stolpe M, Dorfer CE, Paris S. Costs and effectiveness of treatment alternatives for proximal caries lesions. PLoS One. 2014 Jan 27;9(1):e86992. doi: 10.1371/journal.pone.0086992. eCollection 2014. — View Citation
Sihra R, Schroth RJ, Bertone M, Martin H, Patterson B, Mittermuller BA, Lee V, Patterson B, Moffatt ME, Klus B, Fontana M, Robertson L. The Effectiveness of Silver Diamine Fluoride and Fluoride Varnish in Arresting Caries in Young Children and Associated Oral Health-Related Quality of Life. J Can Dent Assoc. 2020 Jun;86:k9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Interproximal caries zone of radiolucency | Bitewing radiographs will be taken of target lesions at Day 1 (baseline). Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS).
Category 1 = Radiolucency in the outer 1/2 of enamel Category 2 = Radiolucency in the inner 1/2 of enamel Category 3 = Radiolucency in the outer 1/3 of dentin |
Baseline | |
Primary | Interproximal caries zone of radiolucency | Bitewing radiographs will be taken of target lesions at 6 months and compared. Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS).
Category 1 = Radiolucency in the outer 1/2 of enamel Category 2 = Radiolucency in the inner 1/2 of enamel Category 3 = Radiolucency in the outer 1/3 of dentin |
6 months | |
Primary | Interproximal caries zone of radiolucency | Bitewing radiographs will be taken of target lesions at 12 months and compared. Target interproximal carious lesion(s) will be rated based on the zone of radiolucency on the radiographs using the International Caries Classification and Management System (ICCMS).
Category 1 = Radiolucency in the outer 1/2 of enamel Category 2 = Radiolucency in the inner 1/2 of enamel Category 3 = Radiolucency in the outer 1/3 of dentin |
12 months |
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