Jordan University of Science and Technology
Irbid, 22110, Jordan
NCT Number: NCT02473471
The purpose of this study is determine the effect the Microosteoperforation (MOPs) using the miniscrew on the rate tooth movement. Moreover, measurement of the level of the pain and pain's interference, the level of satisfaction and comfort using this protocol. Finally root resorption associate with this technique will be evaluated.
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Notify Me16 year–26 year
All sexes
Interventional
Not applicable
Irbid, 22110, Jordan
This study will be randomized, split mouth design controlled trial with a 1:1 allocation ratio. One resident (A.A), calibrated by the main supervisor (S.M), will be reliable for recruiting the subjects, undertaking the orthodontic treatment under the supervision. The eligibility of the cases will be reevaluated by main supervisor (E.M) before the start of treatment.
Split mouth design will be utilized with MOPs that will be randomly assigned to the patients' left or right sides to eliminate the possibility of uneven occlusal forces because of habitual occlusion predominantly on 1 side and also the eliminate the biological variability between subjects. The allocation sequence will be concealed from the researcher (A.A) enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes with the participant's the name and date of birth are written before the intervention. Allocation concealment seeks to prevent selection bias, protects the assignment sequence until allocation.
A Ethical approval will be granted by Jordan University of science and technology research center, and permission will be given at postgraduate dental clinics at Jordan University of science and technology, Irbid, Jordan.
We hypothesized that 50% increased in rate of tooth movement in MOP group would produce a clinically significant difference. The sample size was calculated depend on a type I error frequency of 5%. According to the power analysis and assuming a large effect size difference between groups with 50% of acceleration rate of tooth movement, the power analysis yields a total sample size estimate of 44 samples at a conventional alpha-level (p = 0.05) and desired power (1 - β err prob) of 0.90, yielding 22 samples per group (means 22 patients that represent 22 MOP group and 22 Control group). Assuming an overall attrition rate of 15%, initial recruitment should target a total of 55 samples with 18 patients per group. All calculations were performed with the computer application G-Power (Erdfelder et al., 1996)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cephalometric analysis of the included subjects was performed at baseline including
Three Micro-osteoperforation (MOPs) will be performed distal to canine by Mini screw. Before the application of the MOPs, Patient will be asked to wash their mouth twice by chorhexidine for 1 minute.
Other names: Selective alveolar decortication
Time frame: Baseline to 1st month
The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines.
Time frame: Baseline to 2nd month
The baseline 3D digital model was superimposed to 3D digital models of 2nd month to determine the anterioposterior displacement of canines.
Time frame: Baseline to 3rd month
The baseline 3D digital model was superimposed to 3D digital models of 3rd month to determine the anterioposterior displacement of canines.
Time frame: Baseline to 1st month
Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.
Time frame: Baseline to 2nd month
Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.
Time frame: Baseline to 3 month
Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.
Time frame: Baseline to 3rd month
It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period
Time frame: within 7 days after the intervention
It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.
Time frame: within 7 days after the intervention
It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.
Time frame: within 7 days after the intervention
It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.
Time frame: within 7 days after the intervention
It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no swelling and 10 = worst swelling.
Time frame: within 7 days after the intervention
It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no discomfort and 10 = worst discomfort.
Time frame: After 7 days of MOP application
It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = unsatisfied and 10 = most satisfaction.
Time frame: within 3 months
the relationship between the rate of tooth movement and Menstrual cycle
Jordan University of Science and Technology
Other
Micro-osteoperforations and Tooth Movement: A Randomized Controlled Clinical Trial
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