Long-term remineralizing effect of MI Paste Plus on regression of early caries after orthodontic fixed appliance treatment: A 12-month follow-up randomized controlled trial

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)