The Effects of the Chin Cup on Temporomandibular Joint and Mandibular Dimensions
NCT ID: NCT05350306
Last Updated: 2022-05-04
Study Results
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Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2019-01-01
2022-04-01
Brief Summary
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Detailed Description
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Computed tomography has been considered an ideal tool for evaluating the TMJ with the possibility of determining the real dimensions of the structures under study. Low-dose computed tomography was introduced as an alternative procedure with an effective dose proximately equal to traditional radiographs. Moreover, the volumetric analysis afforded by 3D imaging has proven reliable and accurate in the evaluation of mandibular and condylar sizes. Therefore, the objective of this randomized control trial is to evaluate the dimensional changes in the mandible, condyles, and glenoid fossa after chin cup therapy for children with mandibular prognathism in comparison with untreated Class III patients
Methods: patients ages between 6 and 8 with anterior crossbite, Class III relationships of the permanent first molars or mesial step relationships of the primary second molars, and short-faced pattern, will be selected from the orthodontic department in the faculty of dentistry at Damascus university. Thirty-eight subjects will be enrolled on the study, who will meet the following radiological inclusion criteria based on cephalometric images: Mild to moderate skeletal class III (4- \<the sagittal skeletal angle\< 0 degree), due to mandibular protrusion (SNB \> 80°), and normal or horizontal growth pattern (Bjork's sum ≤396° ±5°).
Patients in the experimental group will receive an individual fabricated bonded bite block and occipital chincup. A 400-500g/side retroactive force will be applied in the direction of the condyles. Patients or panthers will be instructed to wear the appliance /14-16/ hours a day. Pre-(T1) and post-treatment (T2) low-dose computed tomography images will be taken after a positive overjet of 2-4 mm is obtained and undergoing 16 months of active treatment/ observation. The changes in condyle-mandibular volumes and superficial areas and relative positions of the condyles and glenoid fossa will be calculated and compared with those of untreated. Statistical analysis will be done by using the Statistical Package for Social Sciences, Windows version 26.0 (SPSS Inc., Chicago, Illinois, USA) Paired t-test and Wilcoxon signed-rank tests will be used for intragroup comparisons. For the intergroup comparisons, independent t-tests and Mann-Whitney U tests will be carried out.The confidence level is 95% (P\< 0.05).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Chincup
Patients will be treated with occipital chincup and bonded bite block.
Chincup
Patients will receive an individual fabricated bonded bite block and occipital chincup. A 400-500g/side retroactive force will be applied in the direction of the condyles. Patients or panthers will be instructed to wear the appliance /14-16/ hours a day.
Untreated subjects
Patients will not undergone any treatment for 16 months.
Control group
The changes in condyle-mandibular volumes and superficial areas and relative positions of the condyles and glenoid fossa will be calculated after 16 months of observation.
Interventions
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Chincup
Patients will receive an individual fabricated bonded bite block and occipital chincup. A 400-500g/side retroactive force will be applied in the direction of the condyles. Patients or panthers will be instructed to wear the appliance /14-16/ hours a day.
Control group
The changes in condyle-mandibular volumes and superficial areas and relative positions of the condyles and glenoid fossa will be calculated after 16 months of observation.
Eligibility Criteria
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Inclusion Criteria
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.
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
2. craniofacial anomalies
3. history of previous orthodontic treatment
6 Years
8 Years
ALL
No
Sponsors
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Damascus University
OTHER
Responsible Party
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Principal Investigators
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Amr H Husson, DDS,MSc,PhD
Role: PRINCIPAL_INVESTIGATOR
Department of orthodontics, Damascus University, Syria
Mohammad Y Hajeer, DDS,MSc,PhD
Role: STUDY_DIRECTOR
Department of orthodontics, Damascus University, Syria
Ahamd S Burhan, DDS,MSc,PhD
Role: STUDY_DIRECTOR
Department of orthodontics, Damascus University, Syria
Fehmieh R Nawaya, DDS,MSc,PhD
Role: STUDY_DIRECTOR
Department of orthodontics, Damascus University, Syria
Locations
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University of Damascus
Damascus, , Syria
Countries
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References
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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(1):62. doi: 10.1186/s40510-014-0062-9.
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.
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.
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. doi: 10.1016/j.ajodo.2005.11.035.
Lo Giudice A, Ronsivalle V, Grippaudo C, Lucchese A, Muraglie S, Lagravere 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):2798. doi: 10.3390/ma13122798.
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.
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.
Husson AH, Burhan AS, Hajeer MY, Nawaya FR. Evaluation of the dimensional changes in the mandible, condyles, and the temporomandibular joint following skeletal class III treatment with chin cup and bonded maxillary bite block using low-dose computed tomography: A single-center, randomized controlled trial. F1000Res. 2023 Mar 13;12:264. doi: 10.12688/f1000research.130941.1. eCollection 2023.
Other Identifiers
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UDDS-Ortho-09-2022
Identifier Type: -
Identifier Source: org_study_id
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