Study Results
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View full resultsBasic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2015-04-30
2016-11-30
Brief Summary
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Detailed Description
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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)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MOP side
Three small holes in cortical bone can be created by Miniscrews.Before application of the MOPs, Patient will be asked to wash their mouth twice by chlorhexidine for 1 minute. Local anesthesia will be given (2% lidocaine with 1:100,000 epinephrine). Microosteoperforation (MOPs) will be performed distal to canine.
Micro-osteoperforation
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.
control side
No intervention in the other side of maxilla (control side)
No interventions assigned to this group
Interventions
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Micro-osteoperforation
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* between 16 to 26 years old
* Class II Division 1 malocclusion or bimaxillary protrusion
* Average Lower facial height and Mandibular plane angle
* No systemic disease
* Healthy periodontal condition
* Non smoker
* Probing depth less than 4 mm in all teeth
Exclusion Criteria
* Poor oral hygiene
* Low and high angle cases
* Systemic disease
* Evidence of bone loss
* Active periodontal disease
* Smoker
* Probing depth more than 4 mm in all teeth
Cephalometric analysis of the included subjects was performed at baseline including
1. Sella-Nasion to A Point Angle (SNA): Measure Description: Sella-Nasion-A point (SNA) indicates the horizontal position of the maxilla relative to the cranial base.
2. Sella-Nasion to B Point Angle (SNB): Sella-Nasion-B point (SNB) indicates the horizontal position of the mandible relative to the cranial base.
3. A point to B Point Angle (ANB): A point- Nasion-B point (ANB) indicates the skeletal relationship between the maxilla and mandible.
4. Maxillary mandibular plane angle (MM): The angle formed between the Maxillary Plane and Mandibular Plane. Maxillary Plane is the plane demonstrated by a line through the anterior and posterior nasal spines.A mandibular plane is a plane demonstrated by a line through the gonion and menton.
5. Lower anterior facial height(LAFH)
6. Upper incisor inclination: The angle between the maxillary plane and the axis of the maxillary incisors.
16 Years
26 Years
ALL
Yes
Sponsors
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Jordan University of Science and Technology
OTHER
Responsible Party
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Amal Alkebsi
MClindent in Orthodontics, Department of Preventive Dentistry, Faculty of Dentistry
Principal Investigators
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Amal A Alkebsi, MClinDent
Role: PRINCIPAL_INVESTIGATOR
Jordan University of Science and Technology
Emad Al Maaitah, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Jordan University of Science and Technology
Hisham Alshorman, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Jordan University of Science and Technology
Elham S. Abu Alhaija, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Jordan University of Science and Technology
Locations
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Jordan University of Science and Technology
Irbid, , Jordan
Countries
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References
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Alkebsi A, Al-Maaitah E, Al-Shorman H, Abu Alhaija E. Three-dimensional assessment of the effect of micro-osteoperforations on the rate of tooth movement during canine retraction in adults with Class II malocclusion: A randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):771-785. doi: 10.1016/j.ajodo.2017.11.026.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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JordanUST
Identifier Type: -
Identifier Source: org_study_id