Comparisons of esthetic outcomes among treatment modalities for orthodontic-induced white spot lesions: split-mouth randomized clinical trial
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AIM: The aim of this study is to compare, in a randomized clinical trial, the appearance improvement of white spot carious lesions (WSL) treated with resin infiltration (RI) – ICON®, 5% sodium fluoride (22,600 parts per million (ppm) with fluoride varnish (FV), and to assess the synergistic effect of adding Casein Phosphopeptide-Amorphous Calcium Phosphate- MI Paste® (MIP) to these treatment modalities. METHODS: Forty subjects with unrestored WSL, after debanding fixed orthodontic appliances, were recruited from the Department of Orthodontics, Henry M. Goldman School of Dental Medicine, Boston University. A randomized, split-mouth, and double-blind clinical trial design was used to allocate subjects to resin infiltration and fluoride varnish without MI Paste® (RI and FV), 20 patients, and resin infiltration and fluoride varnish with MI Paste® (RI-MIP and FV-MIP), 20 patients. Patients in the MI Paste® present treatment group given 6-weeks supply of MI Paste®. The assessment methods were: 1) patient self-assessment, 2) expert panel subjective assessment, 3) clinical caries assessment using the International Caries Detection and Assessment System (ICDAS), and 4) actual lesion size assessment. Treatment efficacy was assessed after 4-6 weeks of application. The appearance improvement was analyzed at α level of 5% and a power of 90%. RESULTS: Over 4-6 weeks, RI treatment appeared to have a higher mean difference between baseline and follow-up compared to fluoride varnish with a statistically significant difference across all assessment methods. The patient self-assessment mean difference was 1.07 (±1.49); 95% CI [0.59 - 1.55], the expert panel subjective assessment mean difference was 0.75 (±1.06); 95% CI [0.61 - 0.88], the ICDAS mean difference was 0.38 (± 0.43); 95% CI [0.24 - 0.52], and the actual size assessment mean difference was 0.07 (±0.16); 95% CI [0.01 - 0.12]. There was no statistically significant difference between the mean differences between RI and RI-MIP, nor between FV and FV-MIP across all assessment methods. CONCLUSION: The results indicate that RI is significantly better in improving the appearance of WSLs when compared to FV. There is little evidence that use of MIP adds to the improvement of the appearance of WSL in conjunction with either modality.