The Effects of the Chin Cup on Temporomandibular Joint and Mandibular Dimensions

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Chincup is a usual treatment strategy for growing subjects with skeletal Class III malocclusions due to the mandibular overgrowth. However, the review of the literature reveals controversies and contradictions regarding the efficacy of chincup therapy in the retardation of mandibular growth. Moreover, the adaption of the temporomandibular joint (TMJ) following this treatment isn't clear yet. Two recent systematic reviews recommended the need for high-quality studies. 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).

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

Conditions
-----------------
Class III Malocclusion

Intervention / Treatment
-----------------
* Device: Chincup
* Other: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Inclusion criteria: Children ages 6-8 years with anterior crossbite or edge-to-edge incisor relationship. Class III relationships of the permanent first molars or mesial step relationships of the primary second molars. the absence of centric relation and maximum intercuspation discrepancy short-face pattern, adequate overbite. Radiological Inclusion criteria: Mild to moderate skeletal class III (4- <the sagittal skeletal angle (ANB)< 0 degree), due to mandibular protrusion (SNB > 80°). normal or horizontal growth pattern (Bjork's sum ≤396° ±5°) Exclusion Criteria: temporomandibular joint disorders craniofacial anomalies history of previous orthodontic treatment

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chincup<br>Patients will be treated with occipital chincup and bonded bite block. | Device: Chincup<br>* 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.<br>|
| Active Comparator: Untreated subjects<br>Patients will not undergone any treatment for 16 months. | Other: Control group<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chin cup, low-dose computed tomography, condyle-mandibular dimensions