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

NCT05350306 | Completed DMC

• 1 other identifier: UDDS-Ortho-09-2022
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Class III Malocclusion

Keywords

chin cup; low-dose computed tomography; condyle-mandibular dimensions

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (3)

• Change in the anterior joint space (AJS)

  (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)

  (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)

  (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment

Study Arms (2)

Chincup

EXPERIMENTAL

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

Device: Chincup

Untreated subjects

ACTIVE COMPARATOR

Patients will not undergone any treatment for 16 months.

Other: Control group

Interventions

Chincup DEVICE

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.

Chincup

Control group OTHER

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.

Untreated subjects

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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°)

You may not qualify if:

• temporomandibular joint disorders
• craniofacial anomalies
• history of previous orthodontic treatment

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (8)

• 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.

  PMID: 25679781 BACKGROUND

• 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.

  PMID: 20936970 BACKGROUND

• 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.

  PMID: 25179261 BACKGROUND

• 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.

  PMID: 16979502 BACKGROUND

• 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.

  PMID: 32575875 BACKGROUND

• 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.

  PMID: 24325970 BACKGROUND

• 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.

  PMID: 19361736 BACKGROUND

• 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.

  PMID: 37008891 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class III

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Amr H Husson, DDS,MSc,PhD

  Department of orthodontics, Damascus University, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS,MSc,PhD

  Department of orthodontics, Damascus University, Syria

  STUDY DIRECTOR

• Ahamd S Burhan, DDS,MSc,PhD

  Department of orthodontics, Damascus University, Syria

  STUDY DIRECTOR

• Fehmieh R Nawaya, DDS,MSc,PhD

  Department of orthodontics, Damascus University, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: January 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)