M Beerens

EFFECTS OF MI PASTE PLUS ® : A 12-MONTHS FOLLOW-UP 5 87 U -test was used to determine differences between both groups at debonding and 1-year post-debonding. The intraclass correlation coefficients (ICCs) were calculated to determine intra- and inter-examiner agreement. Intra- and inter- examiner agreements for the QLF images were high (ICC = 0.93 M.W.B. intra; ICC = 0.87 M.W.B. with experienced examiner MHV). Intra- and inter-examiner agreements for clinical photographs using ICDAS were calculated for examiner 1 (F.B.) and examiner 2 (M.W.B.): ICC = 0.65 (T1) and 0.73 (T5) F.B. intra; ICC = 0.66 (T1) and 0.72 (T5) M.W.B. intra; ICC = 0.71 (T1) and 0.73 (T5) F.B. with M.W.B.. The level of significance for all tests was set at 5 %. Subjects with missing interim data were included. Data were supplemented by the average of the previous and following data point by assessing the means. RESULTS Eligible participants were recruited from January 2008 to August 2009. From the 184 screened participants, 65 were enrolled in the study and randomly assigned into two groups: the MI Paste Plus ® group (group A; n = 35) and the control group (group B; n = 30). All participants received intended treatment. Inclusion of participants stopped when at least 30 subjects were enrolled in each groups and seen at the 6-week visit. A flow diagram, from enrolment and group allocation to study conclusion, is shown in Figure 2. A total of 14 patients dropped out between T0 and T5, 10 from the MI Paste Plus ® group and 4 from the control group. Reasons given for withdrawal were the time-consuming nature of the study or a shift of patient’s priority. Furthermore, exclusion after randomization occurred for one participant from the MI Paste Plus ® group where WSL were detected prior to debonding, but who was found to be WSL free after debonding. Fifty-one participants (27 males and 24 females; mean age ± SD, 15.32 ± 1.6 years) completed the study. A total of 25 participants were analysed in the MI Paste Plus ® group versus 26 in the control group. In Table 1, an overview of baseline data is given per intervention. No significant differences were found with respect to gender ratio, age of the participants, treatment duration, the number of decayed, missing (due to caries) and filled surfaces of permanent teeth (DMFS), and bleeding on probing. Electric- and manual- brushing methods were distributed similar over the groups at baseline.