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Patients with class II malocclusion and retrognathic mandibles will be treated using functional appliances and asses the remodeling that is expected to occur in the temporomandibular joint (TMJ) using cone-beam computed tomography (CBCT) images and we will register mandibular movements using electronic axiograph ( a specific apparatus used to record jaw movements in three dimensions).
There are three groups :
Patients will be allocated to the three groups randomly.
Data will be collected using three different approaches:
The main purposes of this project are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activator | Active Comparator | Patients will be treated using the Activator appliance for one and a half year |
|
| Twin Block | Experimental | Patients will be treated using the Twin Block appliance for 18 months on average |
|
| Control | No Intervention | Patients will be monitored until the last assessment times in the other groups. This group will serve as a control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activator | Device | This appliance is constructed in one piece to guide the position of the mandible on closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glenoid Fossa Height | Glenoid fossa height: the vertical space between the roof and lowest edge of the fossa. This measurement will be done on the 3D software (3D OnDemand) using CBCT images | T1: at one day before the commencement of treatment; T2: after 12 months of treatment |
| Change in Glenoid Fossa Width | Glenoid fossa width: the horizontal space between the anterior and posterior wall of the fossa. This measurement will be done on the 3D software (3D OnDemand) using CBCT images | T1: at one day before the commencement of treatment; T2: after 12 months of treatment |
| Change in Articular Eminence Inclination | Articular Eminence inclination: the angle between a horizontal plane and the posterior slope of the articular eminence. This measurement will be done on the 3D software (3D OnDemand) using CBCT images | T1: at one day before the commencement of treatment; T2: after 12 months of treatment |
| Change in Condylar Height | Condylar Height: the vertical height of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images | T1: at one day before the commencement of treatment; T2: after 12 months of treatment |
| Change in Condylar Width | Condylar Width: the horizontal width of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images | T1: at one day before the commencement of treatment; T2: after 12 months of treatment |
| Change in Condylar Length | Condylar Length: the mesio-distal length of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images |
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Inclusion Criteria:
Class II malocclusion Skeletal class II with retruded mandibles. Old between 10-13 years Healthy TMJ Horizontal or normal growth pattern
Exclusion Criteria:
Patients who have been treated previously Patients with syndromes or congenital deformities Signs or symptoms of temporomandibular disorders.
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| Name | Affiliation | Role |
|---|---|---|
| Abdulmalek Majanni, DDS MSc | PhD Student in Orthodontics, University of Damascus Dental School, Damascus | Principal Investigator |
| Mohammad Y Hajeer, DDS MSc PhD | Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria | Study Chair |
| Issam Khoury, DDS MSc PhD | Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, SYRIA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthodontic Department, University of Damascus Dental School | Damascus | DM20AM18 | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20578854 | Background | Aidar LA, Dominguez GC, Yamashita HK, Abrahao M. Changes in temporomandibular joint disc position and form following Herbst and fixed orthodontic treatment. Angle Orthod. 2010 Sep;80(5):843-52. doi: 10.2319/093009-545.1. | |
| 25564505 | Background | Cacho A, Ono T, Kuboki T, Martin C. Changes in joint space dimension after the correction of Class II division 1 malocclusion. Eur J Orthod. 2015 Oct;37(5):467-73. doi: 10.1093/ejo/cju091. Epub 2015 Jan 6. |
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| ID | Term |
|---|---|
| D008312 | Malocclusion, Angle Class II |
| D063173 | Retrognathia |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007569 | Jaw Abnormalities |
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| ID | Term |
|---|---|
| D000202 | Activator Appliances |
| ID | Term |
|---|---|
| D017289 | Orthodontic Appliances, Functional |
| D009967 | Orthodontic Appliances |
| D009970 | Orthodontics |
| D003813 | Dentistry |
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| Twin Block | Device | This appliance is constructed in two pieces to guide the position of the mandible on closure |
|
|
| T1: at one day before the commencement of treatment; T2: after 12 months of treatment |
| Change in Condylar Circumference | Condyle circumference: the outer circumference of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images | T1: at one day before the commencement of treatment; T2: after 12 months of treatment |
| Change in the Anterior Joint Space | Anterior Joint Space: the space between the anterior edge of condyle and the posterior slope of the articular eminence. This measurement will be done on the 3D software (3D OnDemand) using CBCT images | T1: at one day before the commencement of treatment; T2: after 12 months of treatment |
| Change in the Superior Joint Space | Superior Joint Space: the space between the superior edge of the condyle and the roof of the fossa. This measurement will be done on the 3D software (3D OnDemand) using CBCT images | T1: at one day before the commencement of treatment; T2: after 12 months of treatment |
| Change in the Posterior Joint Space | Posterior joint space: the space between the posterior edge of the condyle and the posterior board of the fossa. This measurement will be done on the 3D software (3D OnDemand) using CBCT images | T1: at one day before the commencement of treatment; T2: after 12 months of treatment |
| Change in Border Mandibular Movements | Border mandibular movements will be measured on the axiograph apparatus (called Arcosdigma(R)). | T1: at one day before the commencement of treatment; T2: after 12 months of treatment |
| Change in the Discrepancy between CO and CR | CO-CR discrepancy: we will measure distance between centric relation and centric occlusion in three dimensions (sagittal, coronal and axial ). These measurements will be done by an electronic axiograph (Arcosdigma(R)) | T1: at one day before the commencement of treatment; T2: after 12 months of treatment |
| 11244427 | Background | Arat ZM, Gokalp H, Erdem D, Erden I. Changes in the TMJ disc-condyle-fossa relationship following functional treatment of skeletal Class II Division 1 malocclusion: a magnetic resonance imaging study. Am J Orthod Dentofacial Orthop. 2001 Mar;119(3):316-9. doi: 10.1067/mod.2001.110245. |
| 25329768 | Background | Chavan SJ, Bhad WA, Doshi UH. Comparison of temporomandibular joint changes in Twin Block and Bionator appliance therapy: a magnetic resonance imaging study. Prog Orthod. 2014 Oct 1;15(1):57. doi: 10.1186/s40510-014-0057-6. |
| 26434757 | Background | Cimic S, Badel T, Simunkovic SK, Pavicin IS, Catic A. Centric slide in different Angle's classes of occlusion. Ann Anat. 2016 Jan;203:47-51. doi: 10.1016/j.aanat.2015.09.001. Epub 2015 Sep 30. |
| 3422118 | Background | Clark WJ. The twin block technique. A functional orthopedic appliance system. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):1-18. doi: 10.1016/0889-5406(88)90188-6. No abstract available. |
| 27152081 | Background | Costea CM, Badea ME, Vasilache S, Mesaros M. Effects of CO-CR discrepancy in daily orthodontic treatment planning. Clujul Med. 2016;89(2):279-86. doi: 10.15386/cjmed-538. Epub 2016 Apr 15. |
| D007571 |
| Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D008336 | Mandibular Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009968 |
| Orthodontic Appliances, Removable |