The purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay.
A 3-year prospective, randomized control clinical trial (RCT) is designed incorporating a split mouth intra-oral design. Young volunteers (18-24 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by resin infiltration therapy as adjunct to standard-of-care preventative measures. Lesion status (non-cavitated) is clinically confirmed prior to implementing the assigned therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification. ICON product: FDA-510(k): K100062
Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.
Saunders USADC
West Point, New York, United States
Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)
Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year)
Time frame: 3 Years
Number of Lesions With Progression as Measured by Depth Category (N=Lesions)
Radiographic lesion depth categories: E2 (inner enamel), D1 (outer dentin) and D2-rest (middle dentin or restored). Lesion depth assessment on single radiograph (baseline, 3 yr).
Time frame: 3 Years
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