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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2018 |
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Main ID: |
NCT02865213 |
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Date of registration:
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22/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Molar Intrusion in Open Bite Treatment
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Scientific title:
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Assessment of Skeletal and Dentoalveolar Changes Resulting From Posterior Teeth Intrusion in Treatment of the Anterior Open Bite - a Randomized Controlled Trial |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02865213 |
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Study type:
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Interventional |
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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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Mohamad Yousef, DDS MSc PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Damascus University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with skeletal open bite determined by an increased B angle (angle between the
maxillary plane and mandibular plane), the Sum of Bjork and the mandibular plane angle
(angle between SN plane and mandibular plane).
- Patients between 12 and 18 years old in permanent dentition stage.
- Negative over-bite of more than a mm
- Class I or Class II skeletal anteroposterior relationship.
Exclusion Criteria:
- Previous orthodontic treatment.
- Patients with syndromes, clefts, or craniofacial abnormalities.
- Class III skeletal anteroposterior relationship.
Age minimum:
12 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anterior Open Bite
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Intervention(s)
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Device: Miniplates
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Device: Miniscrews
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Device: OBA
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Primary Outcome(s)
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Overbite
[Time Frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months]
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Secondary Outcome(s)
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Mandibular autorotation
[Time Frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months]
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Molar intrusion
[Time Frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months]
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Anterior facial height
[Time Frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months]
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Change in the anteroposterior position of the point "B"
[Time Frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months]
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Secondary ID(s)
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UDDS-Ortho-01-2016
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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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