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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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6 October 2015 |
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Main ID: |
NCT02332421 |
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Date of registration:
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03/01/2015 |
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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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The Use of a Modified Dentoalveolar Distractor to Retract Maxillary Canines
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Scientific title:
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A Comparison Of The Short-Term Therapeutic Effects Between Two Distractors Used For The Retraction Of Maxillary Canines By Dentoalveolar Distraction Osteogenesis |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02332421 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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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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Yassir Al-Medallal, 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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Associate Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School |
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Name:
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Khaled Alainawi, DDS |
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Address:
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Telephone:
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Email:
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Affiliation:
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MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School |
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Name:
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Mohammad Y Hajeer, 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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Associate Professor of Orthodontics, University of Damascus Dental School |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Indication for extraction of upper first premolar and conducting canine retraction
- Good oral hygiene
Exclusion Criteria:
- Buccal or palatal inclination of the canines
- Mesial or distal inclination of the canines
- Contraindication to minor surgery
- Previous orthodontic or surgical treatment
- Root canal treatment to the canines
- Malformation of the canines
Age minimum:
18 Years
Age maximum:
25 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Orthodontic Patients Requiring Canine Retraction
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Intervention(s)
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Device: modified dentoalveolar distractor
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Primary Outcome(s)
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Change in the mesiodistal inclination of the canine
[Time Frame: This will be measured at three times: T0, one day before installing the distractor; T1, in the same day of finishing the retraction phase; T2, in the same day of device removal from the mouth.]
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Secondary Outcome(s)
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Patient acceptance to each distractor
[Time Frame: This is going to be measured at: (T1) first day following surgery, (T2) five days following surgery, (T3) two weeks following surgery, and (T4) at the time of appliance removal.]
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Change in Canine Pulp Vitality
[Time Frame: This will be measured at three times: T0, one day before installing the distractor; T1, in the same day of finishing the retraction phase; T2, in the same day of device removal from the mouth.]
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Molars Anchorage Loss
[Time Frame: Upper first molar position will be measured at three assessment times: T0, one day before installing the distractor; T1, in the same day of finishing the retraction phase; T2, in the same day of device removal from the mouth.]
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Secondary ID(s)
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UDDS-OMFS-02-2015
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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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