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

Primary Purpose

Class III Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Chincup
Control group
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class III Malocclusion focused on measuring chin cup, low-dose computed tomography, condyle-mandibular dimensions

Eligibility Criteria

6 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Damascus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chincup

Untreated subjects

Arm Description

Patients will be treated with occipital chincup and bonded bite block.

Patients will not undergone any treatment for 16 months.

Outcomes

Primary Outcome Measures

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.
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.
Change in the mandibular body (Go-Gn)
Distance between the Gonion point and the Gnathion point.
Change in the ramus height (Co-Go)
Distance between the Condylion point and the Gonion point.
Change in the total body length (Co-Gn)
Distance between the Condylion point and the Gnathion point.
Change in the mandibular angle (GN-Go-CO)
The angle between the Condylion point, the Gonion point and Gnathion point.
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.
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).
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).
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).
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 22, 2022
Last Updated
April 28, 2022
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05350306
Brief Title
The Effects of the Chin Cup on Temporomandibular Joint and Mandibular Dimensions
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class III Malocclusion
Keywords
chin cup, low-dose computed tomography, condyle-mandibular dimensions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chincup
Arm Type
Experimental
Arm Description
Patients will be treated with occipital chincup and bonded bite block.
Arm Title
Untreated subjects
Arm Type
Active Comparator
Arm Description
Patients will not undergone any treatment for 16 months.
Intervention Type
Device
Intervention Name(s)
Chincup
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the mandibular volume and superficial area
Description
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.
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Title
Changes in the condylar volume and superficial area
Description
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.
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Title
Change in the mandibular body (Go-Gn)
Description
Distance between the Gonion point and the Gnathion point.
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Title
Change in the ramus height (Co-Go)
Description
Distance between the Condylion point and the Gonion point.
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Title
Change in the total body length (Co-Gn)
Description
Distance between the Condylion point and the Gnathion point.
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Title
Change in the mandibular angle (GN-Go-CO)
Description
The angle between the Condylion point, the Gonion point and Gnathion point.
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Title
Change in the vertical position of the condyle (CP-FH)
Description
The measurement will be made on the corrected sagittal view: Distance of Condylar posterior point from Frankfort horizontal plane.
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Title
Change in the sagittal position of the condyle (CP-Y)
Description
The measurement will be made on the corrected sagittal view: Distance of Condylar posterior point from Perpendicular plane (Y).
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Title
change in the vertical position of the mandibular fossa (FP-FH)
Description
The measurement will be made on the corrected sagittal view: Distance of Fossa posterior point from Frankfort horizontal plane (FH).
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Title
Change in the sagittal position of the mandibular fossa (FP-Y)
Description
The measurement will be made on the corrected sagittal view: Distance of point Fossa posterior point from Perpendicular plane (Y).
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Title
Quantitative changes of displacement of superimposed 3D mode
Description
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.
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Secondary Outcome Measure Information:
Title
Change in the anterior joint space (AJS)
Description
The measurement will be made on the corrected sagittal view: Distance between Condylar anterior point and Fossa anterior point.
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Title
Chang in the superior joint space (SJS)
Description
The measurements will be made on the corrected sagittal view: Distance between Condylar posterior point and Fossa superior point.
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Title
Chang in the posterior joint space (PJS)
Description
The measurements will be made on the corrected sagittal view: Distance between Condylar posterior point and Fossa posterior point.
Time Frame
(T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr H Husson, DDS,MSc,PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS,MSc,PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahamd S Burhan, DDS,MSc,PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fehmieh R Nawaya, DDS,MSc,PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25679781
Citation
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.
Results Reference
background
PubMed Identifier
20936970
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.
Results Reference
background
PubMed Identifier
25179261
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.
Results Reference
background
PubMed Identifier
16979502
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. doi: 10.1016/j.ajodo.2005.11.035.
Results Reference
background
PubMed Identifier
32575875
Citation
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.
Results Reference
background
PubMed Identifier
24325970
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.
Results Reference
background
PubMed Identifier
19361736
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.
Results Reference
background

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

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