Clinical trial NCT05350306: 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
Overall status: COMPLETED
Phase: NA
Conditions: Class III Malocclusion
Keywords: chin cup
low-dose computed tomography
condyle-mandibular dimensions
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the mandibular volume and superficial area
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
measure: Changes in the condylar volume and superficial area
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
measure: Change in the mandibular body (Go-Gn)
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
measure: Change in the ramus height (Co-Go)
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
measure: Change in the total body length (Co-Gn)
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
measure: Change in the mandibular angle (GN-Go-CO)
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
measure: Change in the vertical position of the condyle (CP-FH)
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
measure: Change in the sagittal position of the condyle (CP-Y)
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
measure: change in the vertical position of the mandibular fossa (FP-FH)
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
measure: Change in the sagittal position of the mandibular fossa (FP-Y)
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
measure: Quantitative changes of displacement of superimposed 3D mode
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Secondary outcomes:
measure: Change in the anterior joint space (AJS)
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
measure: Chang in the superior joint space (SJS)
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
measure: Chang in the posterior joint space (PJS)
timeFrame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: University of Damascus
Study officials:
affiliation: Department of orthodontics, Damascus University, Syria
name: Amr H Husson, DDS,MSc,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of orthodontics, Damascus University, Syria
name: Mohammad Y Hajeer, DDS,MSc,PhD
role: STUDY_DIRECTOR
affiliation: Department of orthodontics, Damascus University, Syria
name: Ahamd S Burhan, DDS,MSc,PhD
role: STUDY_DIRECTOR
affiliation: Department of orthodontics, Damascus University, Syria
name: Fehmieh R Nawaya, DDS,MSc,PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.