Class III Malocclusion Clinical Trial
Official title:
Evaluation of the Dimensional Changes in the Mandible, Condyles, and the Temporomandibular Joint Following Skeletal Class III Treatment With the Chin Cup Using Low-Dose Computed Tomography
Verified date | April 2022 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This in vivo comparative study will evaluate the changes in the mandibular dimensions and the glenoid fossa after skeletal class III subjects' therapy by chincup appliance and compare it with an untreated class III control group. Pre and post-treatment low-dose computed tomography images will be taken before and after achieving positive overjet and undergoing 16 months of active treatment/ observation. Dimensional and volumetric changes in the mandible, condyles, and glenoid fossa will be calculated and compared to those observed in the control group.
Status | Completed |
Enrollment | 38 |
Est. completion date | April 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 8 Years |
Eligibility | Inclusion Criteria: Clinical Inclusion criteria: 1. Children ages 6-8 years with anterior crossbite or edge-to-edge incisor relationship. 2. Class III relationships of the permanent first molars or mesial step relationships of the primary second molars. 3. the absence of centric relation and maximum intercuspation discrepancy 4. short-face pattern, adequate overbite. Radiological Inclusion criteria: 1. Mild to moderate skeletal class III (4- <the sagittal skeletal angle (ANB)< 0 degree), due to mandibular protrusion (SNB > 80°). 2. normal or horizontal growth pattern (Bjork's sum =396° ±5°) Exclusion Criteria: 1. temporomandibular joint disorders 2. craniofacial anomalies 3. history of previous orthodontic treatment |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | University of Damascus | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
Chatzoudi MI, Ioannidou-Marathiotou I, Papadopoulos MA. Clinical effectiveness of chin cup treatment for the management of Class III malocclusion in pre-pubertal patients: a systematic review and meta-analysis. Prog Orthod. 2014 Dec 2;15:62. doi: 10.1186/s40510-014-0062-9. Review. — View Citation
Cordasco G, Portelli M, Militi A, Nucera R, Lo Giudice A, Gatto E, Lucchese A. Low-dose protocol of the spiral CT in orthodontics: comparative evaluation of entrance skin dose with traditional X-ray techniques. Prog Orthod. 2013 Sep 10;14:24. doi: 10.1186/2196-1042-14-24. — View Citation
Ikeda K, Kawamura A. Assessment of optimal condylar position with limited cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):495-501. doi: 10.1016/j.ajodo.2007.05.021. — View Citation
Liu ZP, Li CJ, Hu HK, Chen JW, Li F, Zou SJ. Efficacy of short-term chincup therapy for mandibular growth retardation in Class III malocclusion. Angle Orthod. 2011 Jan;81(1):162-68. doi: 10.2319/050510-244.1. Review. — View Citation
Lo Giudice A, Ronsivalle V, Grippaudo C, Lucchese A, Muraglie S, Lagravère MO, Isola G. One Step before 3D Printing-Evaluation of Imaging Software Accuracy for 3-Dimensional Analysis of the Mandible: A Comparative Study Using a Surface-to-Surface Matching Technique. Materials (Basel). 2020 Jun 21;13(12). pii: E2798. doi: 10.3390/ma13122798. — View Citation
Swennen GR, Schutyser F. Three-dimensional cephalometry: spiral multi-slice vs cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2006 Sep;130(3):410-6. — View Citation
Zurfluh MA, Kloukos D, Patcas R, Eliades T. Effect of chin-cup treatment on the temporomandibular joint: a systematic review. Eur J Orthod. 2015 Jun;37(3):314-24. doi: 10.1093/ejo/cju048. Epub 2014 Sep 1. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the mandibular volume and superficial area | After a semiautomatic segmentation will be utilized to isolate the mandibular bone, the mandible will be rendered in high-quality 3D model. Then, the crowns of the teeth will be removed by a plane passing through 1 mm inferior to the alveolar bone and 10 mm distal to the second primary molars. The mandible volumes and surface sizes will be automatically calculated by the software in mm3 and mm2, respectively. | (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment | |
Primary | Changes in the condylar volume and superficial area | The condyles will be cut from 3D rendered mandibular model at neck level using a plane parallel to the Frankfort horizontal plane at the most inferior part of the sigmoid notch, the condyle volumes and surface sizes will be automatically calculated by the software in mm3 and mm2, respectively. | (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment | |
Primary | Change in the mandibular body (Go-Gn) | Distance between the Gonion point and the Gnathion point. | (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment | |
Primary | Change in the ramus height (Co-Go) | Distance between the Condylion point and the Gonion point. | (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment | |
Primary | Change in the total body length (Co-Gn) | Distance between the Condylion point and the Gnathion point. | (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment | |
Primary | Change in the mandibular angle (GN-Go-CO) | The angle between the Condylion point, the Gonion point and Gnathion point. | (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment | |
Primary | Change in the vertical position of the condyle (CP-FH) | The measurement will be made on the corrected sagittal view: Distance of Condylar posterior point from Frankfort horizontal plane. | (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment | |
Primary | Change in the sagittal position of the condyle (CP-Y) | The measurement will be made on the corrected sagittal view: Distance of Condylar posterior point from Perpendicular plane (Y). | (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment | |
Primary | change in the vertical position of the mandibular fossa (FP-FH) | The measurement will be made on the corrected sagittal view: Distance of Fossa posterior point from Frankfort horizontal plane (FH). | (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment | |
Primary | Change in the sagittal position of the mandibular fossa (FP-Y) | The measurement will be made on the corrected sagittal view: Distance of point Fossa posterior point from Perpendicular plane (Y). | (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment | |
Primary | Quantitative changes of displacement of superimposed 3D mode | The T1 and T2 3D volumes will be superimposed manually followed by automatic global registration. The point-based analysis will be performed to assess the changes in 3D mandibular models between T1 and T2, and a colour map will be produced. Quantitative mean, minimum, and maximum values of part analyses will be reported for comparative analyses. | (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment | |
Secondary | Change in the anterior joint space (AJS) | The measurement will be made on the corrected sagittal view: Distance between Condylar anterior point and Fossa anterior point. | (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment | |
Secondary | Chang in the superior joint space (SJS) | The measurements will be made on the corrected sagittal view: Distance between Condylar posterior point and Fossa superior point. | (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment | |
Secondary | Chang in the posterior joint space (PJS) | The measurements will be made on the corrected sagittal view: Distance between Condylar posterior point and Fossa posterior point. | (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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