Optimum Micro-osteoperforations Accelerated Tooth Movement Interval, Related Pain Perception and Impact to Daily Functions - A Randomized Controlled Trial

1. TRIAL DESIGN This is a prospective randomized clinical trial and single centre study (Faculty of Dentistry, University of Malaya). Participants included are molar class I malocclusion, molar Class II & III < ½ unit, requiring extraction of all four permanent first premolar and maximum anchorage control with Temporary Anchorage Device (TAD).
2. SAMPLE SIZE CALCULATION Sample size calculation is based on a type 1 error frequency of 5% and the power of the statistical test set at 90% ( P = 0.9, B = 0.1 ) This is based on animal study as a guide to detect at least 50% difference in the rate of tooth movement. ( Teixeira CC et al.,2010). The sample size was calculated based on a formula described by Lisa Kuramoto from Vancouver Coastal Health Research Institute. Total participant needed with be 30 with minimum of 10 participants per group. We anticipate 20% drop-outs based on previous study. Thus, a minimum of 36 participants will be recruited.

4. ETHICAL APPROVAL Approval for the conduct of this study had been obtained from Medical Ethics Committee, University of Malaya 5. RANDOMIZATION This study will be conducted by one orthodontic resident together with one orthodontic Consultant from Faculty of Dentistry, University Malaya, who is the main supervisor of this study. A simple randomization method will be employed to assign patient into experimental site and also the for the frequency interval of micro-osteoperforation.

6. INTERVENTION Sequence of events during clinical trial is as follows:-

1. Diagnostic record taking (Study models, Photographs, and x-ray)
2. Randomization for experimental sites in maxilla and mandible & randomization for interval of micro-osteoperforation (Group 1: 4weeks maxilla & 8weeks mandible, Group 2: 8weeks maxilla & 12weeks mandible, Group 3: 12 weeks maxilla & 4 weeks mandible)
3. Treatment planning with Orthodontic Consultant
4. Placement of TADs bilaterally in maxilla and mandible & Clinical calibration for inter-observer error
5. Referral for extraction of 14,24,34 and 44 (Extraction must be done within 2 weeks after insertion of TADs)
6. One month after extraction, Banding and Bonding of upper and lower preadjusted edgewise fixed appliances (MBT prescription 0.022"x 0.028" slot).
7. Arch wire sequence for levelling and aligning are as follows:-

• Upper and lower 0.014 NiTi Arch wire
• Upper and lower 0.018 NiTi Arch wire
• Upper and lower 17 x 25 NiTi Arch wire
• Upper and lower 19 x 25 SS Arch wire