The Effect of Functional Treatment of Patients With Backward Positioned Chins on the Jaw Joint and Movements

Malocclusion, Angle Class II Clinical Trial

Official title:

The Effect of Functional Treatment Using the Activator Versus the Twin Block on the Temporomandibular Joint and the Mandibular Movements in Skeletal Class II Patients: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645343
• Other study ID #: UDDS-Ortho-09-2018
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: November 19, 2019

Study information

• Verified date: January 2020
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with class II malocclusion and retrognathic mandibles will be treated using functional appliances and asses the remodeling that is expected to occur in the temporomandibular joint (TMJ) using cone-beam computed tomography (CBCT) images and we will register mandibular movements using electronic axiograph ( a specific apparatus used to record jaw movements in three dimensions).

There are three groups :

1. Activator Group

2. Twin block Group

3. Control Group with no treatment.

Patients will be allocated to the three groups randomly.

Data will be collected using three different approaches:

• CBCT images before treatment and 12 months after treatment

• Axiograph registrations before treatment and 12 months after treatment

Description:

The main purposes of this project are:

1. to evaluate the remodeling effects that would take place in the bone structures of the temporomandibular joint (TMJ) during functional treatment.

2. to evaluate the possible change that may occur in mandibular movements following functional treatment.

3. to evaluate the possible change in the spatial relationship between centric occlusion (CO) and centric relation (CR) following functional treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 19, 2019
• Est. primary completion date: March 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

Inclusion Criteria:

Class II malocclusion Skeletal class II with retruded mandibles. Old between 10-13 years Healthy TMJ Horizontal or normal growth pattern

Exclusion Criteria:

Patients who have been treated previously Patients with syndromes or congenital deformities Signs or symptoms of temporomandibular disorders.

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class II
• Retrognathia
• Retrognathism
• TMJ

Intervention

Device:
• Activator
This appliance is constructed in one piece to guide the position of the mandible on closure
• Twin Block
This appliance is constructed in two pieces to guide the position of the mandible on closure

Locations

Country	Name	City	State
Syrian Arab Republic	Orthodontic Department, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (7)

Aidar LA, Dominguez GC, Yamashita HK, Abrahão M. Changes in temporomandibular joint disc position and form following Herbst and fixed orthodontic treatment. Angle Orthod. 2010 Sep;80(5):843-52. doi: 10.2319/093009-545.1. — View Citation

Arat ZM, Gökalp H, Erdem D, Erden I. Changes in the TMJ disc-condyle-fossa relationship following functional treatment of skeletal Class II Division 1 malocclusion: a magnetic resonance imaging study. Am J Orthod Dentofacial Orthop. 2001 Mar;119(3):316-9. — View Citation

Cacho A, Ono T, Kuboki T, Martin C. Changes in joint space dimension after the correction of Class II division 1 malocclusion. Eur J Orthod. 2015 Oct;37(5):467-73. doi: 10.1093/ejo/cju091. Epub 2015 Jan 6. — View Citation

Chavan SJ, Bhad WA, Doshi UH. Comparison of temporomandibular joint changes in Twin Block and Bionator appliance therapy: a magnetic resonance imaging study. Prog Orthod. 2014 Oct 1;15:57. doi: 10.1186/s40510-014-0057-6. — View Citation

Cimic S, Badel T, Šimunkovic SK, Pavicin IS, Catic A. Centric slide in different Angle's classes of occlusion. Ann Anat. 2016 Jan;203:47-51. doi: 10.1016/j.aanat.2015.09.001. Epub 2015 Sep 30. — View Citation

Clark WJ. The twin block technique. A functional orthopedic appliance system. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):1-18. — View Citation

Costea CM, Badea ME, Vasilache S, Mesaros M. Effects of CO-CR discrepancy in daily orthodontic treatment planning. Clujul Med. 2016;89(2):279-86. doi: 10.15386/cjmed-538. Epub 2016 Apr 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glenoid Fossa Height	Glenoid fossa height: the vertical space between the roof and lowest edge of the fossa.; This measurement will be done on the 3D software (3D OnDemand) using CBCT images	T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary	Change in Glenoid Fossa Width	Glenoid fossa width: the horizontal space between the anterior and posterior wall of the fossa.; This measurement will be done on the 3D software (3D OnDemand) using CBCT images	T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary	Change in Articular Eminence Inclination	Articular Eminence inclination: the angle between a horizontal plane and the posterior slope of the articular eminence. This measurement will be done on the 3D software (3D OnDemand) using CBCT images	T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary	Change in Condylar Height	Condylar Height: the vertical height of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images	T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary	Change in Condylar Width	Condylar Width: the horizontal width of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images	T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary	Change in Condylar Length	Condylar Length: the mesio-distal length of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images	T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary	Change in Condylar Circumference	Condyle circumference: the outer circumference of the head of the condyle. This measurement will be done on the 3D software (3D OnDemand) using CBCT images	T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary	Change in the Anterior Joint Space	Anterior Joint Space: the space between the anterior edge of condyle and the posterior slope of the articular eminence.; This measurement will be done on the 3D software (3D OnDemand) using CBCT images	T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary	Change in the Superior Joint Space	Superior Joint Space: the space between the superior edge of the condyle and the roof of the fossa.; This measurement will be done on the 3D software (3D OnDemand) using CBCT images	T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary	Change in the Posterior Joint Space	Posterior joint space: the space between the posterior edge of the condyle and the posterior board of the fossa.; This measurement will be done on the 3D software (3D OnDemand) using CBCT images	T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary	Change in Border Mandibular Movements	Border mandibular movements will be measured on the axiograph apparatus (called Arcosdigma(R)).	T1: at one day before the commencement of treatment; T2: after 12 months of treatment
Primary	Change in the Discrepancy between CO and CR	CO-CR discrepancy: we will measure distance between centric relation and centric occlusion in three dimensions (sagittal, coronal and axial ). These measurements will be done by an electronic axiograph (Arcosdigma(R))	T1: at one day before the commencement of treatment; T2: after 12 months of treatment