This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.
A 3-year longitudinal, prospective, randomized control clinical trial (RCT) is designed incorporating a split-mouth intra-oral design. Young volunteers (14-35 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 infiltrating the lesions. The infiltration protocol included application of on-market materials and applicators, and was performed in one session.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
17
Split-mouth design (at least two lesions per patient): Treatment of one caries lesion with resin infiltration therapy
Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements
University of Toledo Medical Center
Toledo, Ohio, United States
Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)
Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).
Time frame: Baseline through 3 years
Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories
Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).
Time frame: Baseline through 3 years
Lesion Survival After 3 Years
Discrete time survival analysis of time to first lesion progression.
Time frame: 3 years
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