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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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4 May 2015 |
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Main ID: |
NCT02144324 |
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Date of registration:
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16/05/2014 |
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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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Changes Following the Treatment of Lower Jaw Protrusion Using Two Appliances
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Scientific title:
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A Comparison of the Skeletal and Dento-alveolar Changes After Treatment of Class III Malocclusion With a Modified Tandem Appliance Versus the Face Mask |
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Date of first enrolment:
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May 2014 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02144324 |
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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, 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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Ahamd Burhan, 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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Senior Lecturer in Orthodontics, University of Al-Baath Dental School, Hamah, Syria |
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Name:
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Amro Husson, 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, Department of Orthodontics, University of Damascus Dental School |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Skeletal Class III (ANB angle < 0 degree) with due to maxillary retrusion, or a
combination of maxillary retrusion and mandibular protrusion.
2. Angle Class III malocclusion with an anterior crossbite.
3. An optimum SN/GoGn angle (between 26 and 38 degrees).
4. Fully erupted maxillary incisors.
Exclusion Criteria:
1. Congenitally missing teeth or congenital syndromes such as a cleft lip/palate
2. History of previous orthodontic treatment
Age minimum:
8 Years
Age maximum:
10 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Class III Malocclusion in Growing Patients
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Intervention(s)
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Device: Tandem Appliance
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Primary Outcome(s)
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Change in the SNA angle
[Time Frame: This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.]
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Change in the spatial position of Point A
[Time Frame: This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.]
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Secondary Outcome(s)
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Change in the overjet value
[Time Frame: This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.]
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Change in the SNB angle
[Time Frame: This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.]
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Secondary ID(s)
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UDDS-Ortho-01-2014
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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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