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Completed

NCT Number: NCT05350306

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

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.

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Key information

Conditions

Class III Malocclusion Malocclusion Malocclusion, Angle Class III Stomatognathic Diseases Tooth Diseases

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Damascus

Damascus, Syria

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in the mandibular volume and superficial area

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

    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.

  2. Changes in the condylar volume and superficial area

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

    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.

  3. Change in the mandibular body (Go-Gn)

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

    Distance between the Gonion point and the Gnathion point.

  4. Change in the ramus height (Co-Go)

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

    Distance between the Condylion point and the Gonion point.

  5. Change in the total body length (Co-Gn)

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

    Distance between the Condylion point and the Gnathion point.

  6. Change in the mandibular angle (GN-Go-CO)

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

    The angle between the Condylion point, the Gonion point and Gnathion point.

  7. Change in the vertical position of the condyle (CP-FH)

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

    The measurement will be made on the corrected sagittal view: Distance of Condylar posterior point from Frankfort horizontal plane.

  8. Change in the sagittal position of the condyle (CP-Y)

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

    The measurement will be made on the corrected sagittal view: Distance of Condylar posterior point from Perpendicular plane (Y).

  9. change in the vertical position of the mandibular fossa (FP-FH)

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

    The measurement will be made on the corrected sagittal view: Distance of Fossa posterior point from Frankfort horizontal plane (FH).

  10. Change in the sagittal position of the mandibular fossa (FP-Y)

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

    The measurement will be made on the corrected sagittal view: Distance of point Fossa posterior point from Perpendicular plane (Y).

  11. Quantitative changes of displacement of superimposed 3D mode

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

    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 outcomes

  1. Change in the anterior joint space (AJS)

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

    The measurement will be made on the corrected sagittal view: Distance between Condylar anterior point and Fossa anterior point.

  2. Chang in the superior joint space (SJS)

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

    The measurements will be made on the corrected sagittal view: Distance between Condylar posterior point and Fossa superior point.

  3. Chang in the posterior joint space (PJS)

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

    The measurements will be made on the corrected sagittal view: Distance between Condylar posterior point and Fossa posterior point.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2022
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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