- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02424422
The Effect of Expansion on Craniofacial Sutures in Children Using 3D Imaging
The Effect of Rapid Maxillary Expansion on Craniofacial Sutures in Children Using Cone Beam Computed Tomography
The aim of this study to test the immediate effect of rapid maxillary expansion on craniofacial sutures in children using cone beam computed tomography.
Materials and Methods: Subjects consisted of 15 growing patients between the ages of 8 and 12 with Skeletal transverse maxillary deficiency with unilateral or bilateral posterior cross bite.
All patients will be treated with A bonded Hyrax (a rapid palatal expander with an acrylic occlusal splint). The planned activation protocol consisted of 2 turns per day (0.25 mm per turn) until the resolution of posterior cross bite with 2 to 3 mm overcorrection of expansion then tying off the jackscrew with a ligature wire and placing a smooth composite material over it. The initial CBCT scan (T0) will be taken before cementation of the maxillary expander and again immediately after the end of the active expansion (T1). First, all CBCT images will be oriented then the craniofacial sutures(Intermaxillary Suture, Midpalatal Suture, Transpalatal Suture, Internasal Suture, Frontonasal suture, Zygomaticotemporal suture, Frontomaxillary suture, Zygomaticomaxillary suture, Nasomaxillary sutures, Spheno-occipital synchondrosis) will be examined. Where the linear measurements will be carried out directly on the CBCT image using the OnDemand 3D Imaging software program.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Damascsus
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Damascus, Damascsus, Syrian Arab Republic, DM20AM18
- Department of Orthodontics, University of Damascus Dental School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Growing patients between the age of 8 and 12 will be recruited from those who are visiting the Department of Orthodontics at University of Damascus Dental School.
The study will evaluate the impact of maxillary expansion on craniofacial sutures using CBCT imaging.
Description
Inclusion Criteria:
- skeletal maxillary transverse deficiency
- age between 8 and 12
- not previously treated orthodontically
- no presence of craniofacial syndromes or congenital deformities
- presence of unilateral or bilateral cross-bites
Exclusion Criteria:
- previous orthodontic treatment
- absence of any posterior cross-bite
- presence of any congenital malformations or dentofacial syndromes
- patients of non-Syrian ancestry
- mental retardation
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in craniofacial suture width
Time Frame: A CBCT image will be taken before the commencement of maxillary expansion and anther CBCT image will be taken within 3 days following orthopedic appliance removal
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The distance between the two edges of each suture. The following sutures will be measured: Intermaxillary Suture, Midpalatal Suture, Transpalatal Suture, Internasal Suture, Frontonasal suture, Zygomaticotemporal suture, Frontomaxillary suture, Zygomaticomaxillary suture, Nasomaxillary sutures, Spheno-occipital synchondrosis |
A CBCT image will be taken before the commencement of maxillary expansion and anther CBCT image will be taken within 3 days following orthopedic appliance removal
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nemat Al-Kaissi, DDS, MSc student at the Department of Orthodontics, University of Damascus Dental School
- Study Director: Mowaffak Ajaj, DDS MSc PhD, Associate Professor of Orthodontics, University of Damascus Dental School
Publications and helpful links
General Publications
- Bazargani F, Feldmann I, Bondemark L. Three-dimensional analysis of effects of rapid maxillary expansion on facial sutures and bones. Angle Orthod. 2013 Nov;83(6):1074-82. doi: 10.2319/020413-103.1. Epub 2013 Jun 7.
- Leonardi R, Cutrera A, Barbato E. Rapid maxillary expansion affects the spheno-occipital synchondrosis in youngsters. A study with low-dose computed tomography. Angle Orthod. 2010 Jan;80(1):106-10. doi: 10.2319/012709-56.1.
- Leonardi R, Sicurezza E, Cutrera A, Barbato E. Early post-treatment changes of circumaxillary sutures in young patients treated with rapid maxillary expansion. Angle Orthod. 2011 Jan;81(1):36-41. doi: 10.2319/050910-250.1.
- Gardner GE, Kronman JH. Cranioskeletal displacements caused by rapid palatal expansion in the rhesus monkey. Am J Orthod. 1971 Feb;59(2):146-55. doi: 10.1016/0002-9416(71)90046-7. No abstract available.
- Lee H, Ting K, Nelson M, Sun N, Sung SJ. Maxillary expansion in customized finite element method models. Am J Orthod Dentofacial Orthop. 2009 Sep;136(3):367-74. doi: 10.1016/j.ajodo.2008.08.023.
- Mah JK, Huang JC, Choo H. Practical applications of cone-beam computed tomography in orthodontics. J Am Dent Assoc. 2010 Oct;141 Suppl 3:7S-13S. doi: 10.14219/jada.archive.2010.0361.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UDDS-Ortho-01-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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