Study design: Double blind randomised controlled trial
Intervention: Sixty patients undergoing orthodontic treatment were randomised to receive either MI Paste Plus (GC America, Alsip III) or a placebo paste (Tom's of Main, Salisbury, UK). To be included, the patients had to be 12 years of age or over, in the permanent dentition, and be considered to be compliant with using the paste. Patients were excluded if they; had been undergoing extensive fluoride regimes, had an impacting medical or dental condition, had been receiving fluoride treatment for white spots, be planning to move within 6 months, or have an allergy to IgE casein. The pastes were self-administered in a fluoride tray for 3 to 5 minutes each night after brushing, for a period of 3 months.
Outcome measures: Outcomes were measured at baseline, then at 4, 8, and 12 weeks into treatment) using 2 measures. Standardised photographic records were used to assess WSLs using Banks and Richmond's decalcification index score, from first premolar to first premolar in the maxilla and mandible. Three operators scored the photographs independently. The International Caries Detection and Assessment System (ICDAS) was used for the labial surfaces of the teeth and the scores (0-6) for surfaces were added together to give an overall score.
Results: Five patients refused to participate before the trial began and out of the 60 patients randomised, 50 completed the study (26 MI Paste Plus group 24 in placebo group). There was a 53.5% in the enamel decalcification index score in the MI Paste Plus group but an increase of 91.1% in the placebo group at the end of the 12 week period; ICDAS scores were added together to give an overall score for all teeth; the MI Paste Plus group score was 145 at baseline and 80 after 12 weeks, a 44.8%reduction; in the placebo group, the scores were 116 and 166 respectively, an increase of 43%.
Conclusions: MI Paste Plus prevented and decreased the number of WSLs during orthodontic treatment with the placebo paste group having an increase in the number of WSLs during the trial. These effects were most noticeable on the gingival surfaces. Incisal enamel decalcification index scores were consistently higher than other tooth surfaces, including gingival.