Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03149016 |
Date of registration:
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09/05/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The Use of Corticotomy for Upper Incisors Retraction
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Scientific title:
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Evaluation of Treatment Outcomes of Corticotomy-accelerated Upper Incisors' Retraction: A Randomized Controlled Trial |
Date of first enrolment:
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August 20, 2016 |
Target sample size:
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30 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03149016 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Syrian Arab Republic
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Contacts
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Name:
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Ghaith Al Imam, DDS |
Address:
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Telephone:
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Email:
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Affiliation:
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MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients 15 to 27 years , with permanent dentition , without hypodontia .
- Overjet less than 10 mm
- Normal or increased growth pattern (Diagnosed by Y-axis angle)
- Mild to moderate crowding (Less than 3 mm)
- After canines retraction , at least 3 mm space should be available distal the lateral
incisors
- Midline deviation shouldn't be more than 3 mm
Exclusion Criteria:
- Medically contraindicated patients to oral surgery .
- Existence of general health issue that affect orthodontic teeth movement
- Previous orthodontic treatment
- Mixed dentition
- Hypodontia (Except third molars)
- Bad oral hygiene
Age minimum:
15 Years
Age maximum:
27 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Class II Division 1 Malocclusion
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Intervention(s)
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Procedure: Corticotomy-assisted Retraction
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Primary Outcome(s)
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Rate of retraction
[Time Frame: This will be measured at the completion of the retraction procedure, and is expected to take 2 months in the experimental group and four months in the control group.]
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Time required for retraction
[Time Frame: This will be measured at the completion of the retraction procedure, and is expected to be within 2 months in the accelerated group and 4 months in the control group.]
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Secondary Outcome(s)
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Change in the axial inclination of upper incisors
[Time Frame: A radiograph will be taken at T1: one day before upper incisors' retraction and T2: one day after the completion of upper incisors' retraction. Completion of upper incisors' retraction is expected to be within 2 months in the accelerated group and 4 mo]
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Anchorage loss
[Time Frame: This will be measured one day following the completion of retraction of the upper four incisors using plaster study models and is expected to be within 2 months in the accelerated group and 4 months in the control group]
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Root resorption
[Time Frame: An panoramic image will be taken at T1: one day before the commencement of incisor retraction and T2: one day following the completion of retraction and is expected to be within 2 months in the accelerated group and 4 months in the control group]
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Secondary ID(s)
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UDDS-Ortho-02-2017
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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