M Beerens

88 CHAPTER 5 Assessed for eligibility (n = 184 ) Enrolment (n = 65 ) Randomization Allocated to intervention Group A (n =35 ) Received allocated intervention (n =35 ) Allocated to intervention Group B (n =30 ) Received allocated intervention (n =30 ) Excluded (n =119 ) Not meeting inclusion criteria: At screening < 2 WSL (n =98 ) At debond < 2 WSL (n =6 ) Caries profunda (n =5 ) To old of age (n =2 ) Partly MB appliance (n =3 ) Extended fluorosis dentalis (n =1 ) S ystemic diseas (n =1 ) Refused to participate (n =2 ) Data at screening incomplete (n =1 ) Allocation Lost to follow-up (n =10 ) Not present at visit ( n =7 ) Decided not to participate any further (n =3 ) Lost to follow-up (n =4 ) Not present at visit ( n =1 ) Decided not to participate any further (n =3 ) Analyzed (n =25 ) Excluded from analysis (n =1 ) No lesions detected Discontinued intervention due to Non-compliance (n =6 ) though included Analyzed (n =26 ) Excluded from analysis (n =0 ) Follow-up Analysis FIGURE 2. Flow of participants through the study. Group A received the MI Paste Plus ® product paste and Group B received the control paste.