RESUMEN
Background: Casein-phosphopeptide-amorphous-calcium-fluoride-phosphate (CPP-ACFP) can remineralize subsurface lesions. It is the active ingredient of MI-Paste-Plus® (MPP). The long-term remineralization efficacy is unknown. Objective: To evaluate the long-term effect of MPP versus a placebo paste on remineralization of enamel after fixed orthodontic treatment over a 12-month period. Design: This trial was designed as a prospective, double-blinded, placebo-controlled RCT. Methods: Patients with subsurface lesions scheduled for removal of the appliance were included. They applied either MPP or control paste once a day at bedtime for 12 months, complementary to normal oral hygiene. Main outcome measures: Changes in enamel lesions (primary outcome) were fluorescence loss and lesion area determined by quantitative light-induced fluorescence (QLF). Secondary outcomes were Microbial composition, by conventional plating, and acidogenicity of plaque, by capillary ion analysis (CIA), and lesion changes scored visually on clinical photographs. Randomization: Participants [age = 15.5 years (SD = 1.6)] were randomly assigned to either the MPP or the control group, as determined by a computer-randomization scheme, created and locked before the start of the study. Participants received neutral-coloured concealed toothpaste tubes marked A or B. Blinding: The patients and the observers were blinded with respect to the content of tube A or B. Results: A total of 51 patients were analysed; MPP (n = 25) versus control group (n = 26); data loss (n = 14). There was no significant difference between the groups over time for all the used outcome measures. There was a significant improvement in enamel lesions (fluorescence loss) over time in both groups (P < 0.001 and P < 0.001), with no differences between groups. Limitations: Being an in vivo study, non-compliance of the subjects could have influenced the result. Conclusion: The additional use of MPP in patients with subsurface enamel lesions after orthodontic fixed appliance treatment did not improve these lesions during the 1 year following debonding. Registration: This trial is registered at the medical ethical committee of the VU Medical Centre in Amsterdam (NL.199226.029.07).