Skeletal Maxillary Transverse DeficiencyNCT02424422
The Effect of Expansion on Craniofacial Sutures in Children Using 3D Imaging
An observational study of Skeletal Maxillary Transverse Deficiency, run by Damascus University at 1 site in Syria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Skeletal Maxillary Transverse Deficiency
- How many people
- 15 participants
- Where
- 1 siteSyria
- Study dates
- Feb 2015to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- previous orthodontic treatment
- absence of any posterior cross-bite
- presence of any congenital malformations or dentofacial syndromes
- patients of non-Syrian ancestry
- mental retardation
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, University of Damascus Dental School
Damascus, Damascsus, DM20AM18
About this study
Official title: 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.
Read the detailed description
Rapid maxillary expansion (RME) treatment has been used widely since the mid 1960s. It is frequently used to correct maxillary width deficiency, posterior crossbite or to expand arch perimeters to alleviate dental crowding or patients with Class III malocclusion who often are treated with RME because of an insufficient maxillary arch width. Although, the major effect of this treatment is noticed clinically in the dentition and maxilla area. RME therapy appears to involve an ample portion of the craniofacial complex, as the maxilla is associated with 10 bones in the face and head. Although, the RME force is concentrated on widening the maxilla, concomitant changes occur in circumaxillary sutures. Moreover, it has been claimed that the transverse forces generated during rapid maxillary expansion are transmitted, via the pterygomaxillary connection, to the unpaired sphenoid bone of the cranial base, where they lead to stress. The extent and effects of this have not yet been studied extensively, nor have they been well determined. In orthodontics, the cranial base has received attention because of the fact that its growth influences the maxillary-mandibular complex. Some authors in fact consider the cranial base as a guide rail for development of the maxilla, midface, and lower facial complex. This involvement has been hypothesized following investigations based on histologic methods, radiologic imaging, photoelastic models, bone scintigraphy, and finite element analysis. However, even though the above studies have been well designed, some issues may have affected their conclusions. In fact, histological findings are limited to experimental studies in animals. Moreover, accuracy of the results of the finite element model (FEM) depends on the detailed geometry, material properties, and boundary conditions of the FEM. Therefore, until now, there have been only speculations about whether RME can or cannot disarticulate these structures in humans. With advanced technology and the introduction of three-dimensional computed tomography imaging, that allow clinicians and researchers to quantitatively evaluate bone changes with minimal distortion and lower radiation dosage, Due to the high dose of x-ray of CT, high cost and the lack of study on the effect of the RME on circumaxillary sutures and spheno-occipital synchondrosis using imaging three-dimensional radiographic (CT). Because of the importance of the effect of the maxillary expansion on maxillary displacement, and the resulting significant clinical effects, especially at the level of improvement in the third class at the children. From here stems the need for this study on the effect of rapid maxillary expansion RME on the craniofacial sutures in children using cone beam computed tomography
- Conditions
- Skeletal Maxillary Transverse Deficiency
- Keywords
- Corrective Orthodontics, CBCT, Rapid Maxillary Expansion, Cone Beam Computed Tomography, Hyrax Expansion, Craniofacial Sutures
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in craniofacial suture width
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Skeletal Maxillary Transverse DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nemat Al-Kaissi, DDS, Principal investigator, MSc student at the Department of Orthodontics, University of Damascus Dental SchoolMowaffak Ajaj, DDS MSc PhD, Study director, Associate Professor of Orthodontics, University of Damascus Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424422
- Sponsor's protocol ID
- UDDS-Ortho-01-2015
- Status last verified
- Jun 2016
- First submitted
- 20 Apr 2015
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 23745976Leonardi 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.
PubMed 19852648Leonardi 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.
PubMed 20936952Gardner 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.
PubMed 4993115Lee 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.
PubMed 19732671Mah 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.
PubMed 20884934
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rapid Maxillary Expansion on Craniofacial Sutures in Children Using Cone Beam Computed Tomography
- ClinicalTrials.gov ID
- NCT02424422
- Acronym / sponsor ID
- UDDS-Ortho-01-2015
- Conditions
- Skeletal Maxillary Transverse Deficiency
- Keywords
- Corrective Orthodontics, CBCT, Rapid Maxillary Expansion, Cone Beam Computed Tomography, Hyrax Expansion, Craniofacial Sutures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rapid maxillary expansion (RME) treatment has been used widely since the mid 1960s. It is frequently used to correct maxillary width deficiency, posterior crossbite or to expand arch perimeters to alleviate dental crowding or patients with Class III malocclusion who often are treated with RME because of an insufficient maxillary arch width. Although, the major effect of this treatment is noticed clinically in the dentition and maxilla area. RME therapy appears to involve an ample portion of the craniofacial complex, as the maxilla is associated with 10 bones in the face and head. Although, the RME force is concentrated on widening the maxilla, concomitant changes occur in circumaxillary sutures. Moreover, it has been claimed that the transverse forces generated during rapid maxillary expansion are transmitted, via the pterygomaxillary connection, to the unpaired sphenoid bone of the cranial base, where they lead to stress. The extent and effects of this have not yet been studied extensively, nor have they been well determined. In orthodontics, the cranial base has received attention because of the fact that its growth influences the maxillary-mandibular complex. Some authors in fact consider the cranial base as a guide rail for development of the maxilla, midface, and lower facial complex. This involvement has been hypothesized following investigations based on histologic methods, radiologic imaging, photoelastic models, bone scintigraphy, and finite element analysis. However, even though the above studies have been well designed, some issues may have affected their conclusions. In fact, histological findings are limited to experimental studies in animals. Moreover, accuracy of the results of the finite element model (FEM) depends on the detailed geometry, material properties, and boundary conditions of the FEM. Therefore, until now, there have been only speculations about whether RME can or cannot disarticulate these structures in humans. With advanced technology and the introduction of three-dimensional computed tomography imaging, that allow clinicians and researchers to quantitatively evaluate bone changes with minimal distortion and lower radiation dosage, Due to the high dose of x-ray of CT, high cost and the lack of study on the effect of the RME on circumaxillary sutures and spheno-occipital synchondrosis using imaging three-dimensional radiographic (CT). Because of the importance of the effect of the maxillary expansion on maxillary displacement, and the resulting significant clinical effects, especially at the level of improvement in the third class at the children. From here stems the need for this study on the effect of rapid maxillary expansion RME on the craniofacial sutures in children using cone beam computed tomography
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- previous orthodontic treatment
- absence of any posterior cross-bite
- presence of any congenital malformations or dentofacial syndromes
- patients of non-Syrian ancestry
- mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Background: PubMed 23745976Bazargani 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.
- Background: PubMed 19852648Leonardi 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.
- Background: PubMed 20936952Leonardi 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.
- Background: PubMed 4993115Gardner 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.
- Background: PubMed 19732671Lee 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.
- Background: PubMed 20884934Mah 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.
- Individual participant dataSharing planned: No
Related trials for Skeletal Maxillary Transverse Deficiency
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Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
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Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
Maxillary Constriction
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Effects of Invisalign Palatal Expander vs Rapid Palatal Expander With Facemask in Growing Class III Patients
Skeletal Class III Malocclusion, Transverse Maxillary Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nemat Al-Kaissi, DDS principal investigator
MSc student at the Department of Orthodontics, University of Damascus Dental School
Mowaffak Ajaj, DDS MSc PhD study director
Associate Professor of Orthodontics, University of Damascus Dental School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skeletal Maxillary Transverse Deficiency, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02424422, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.