Accelerated Tooth Movement Interval Clinical Trial
Official title:
Optimum Micro-osteoperforations Accelerated Tooth Movement Interval, Related Pain Perception and Impact to Daily Functions - A Randomized Controlled Trial
This study is intended to investigate the optimum interval between micro-osteoperforations
to accelerate orthodontic tooth movement. Overall, the investigator will be comparing the
rate of tooth movement between micro-osteoperforated site and non micro-osteoperforated
site. Next, the investigator will be comparing the rate of orthodontic tooth movement for
micro-osteperforation performed at 4, 8 and 12 weeks' intervals. In addition, the
investigator will be evaluating the pain intensity and impact of pain on quality of life
during different intervals of micro-osteoperforations at 4, 8 and 12 weeks. Finally, the
investigator will be comparing the rate of orthodontic tooth movement between maxilla and
mandible.
The significance of the outcome is to determine optimum recommended interval for
micro-osteopeforation which can be used to accelerate orthodontic tooth movement. By finding
out the optimum interval, the investigator can come with a recommended interval of
micro-osteoperforation which can be used routinely in patients to fasten orthodontic tooth
movement.
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
- Dead coil will be placed to maintain the extraction space of premolars
- Interval between each arch wire sequence is 6 weeks
8. One month after the insertion of working arch wire, micro-osteoperforations will be
performed & Inter-obverver error measurement will be done 2 weeks after insertion of
working arch wire and on the day of mirco-osteoperforations.
9. Three micro-osteoperforations will be placed at the buccal aspect on the buccal
cortical bone at the site of premolar extraction(experimental site only) and both
canine will be retracted bilaterally with NiTi Coil Spring.
10. Participants will be given questionnaire after the procedure and the questionnaire will
be collected the following visit 11 From now onwards, participants will be reviewed at
their respective interval. Either 4,8 or 12 weeks interval.
12. This is the critical period of this study in which micro-osteoperforations will be
performed and questionnaire will be given to participants.
13. Data collection will be conducted for a period of 16weeks(4 months) - during canine
retraction
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment