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

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

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

Study Overview

• Status: Completed
• Conditions: Malocclusion, Angle Class II; Retrognathism; TMJ
• Intervention / Treatment: Device: Activator; Device: Twin Block

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20AM18
    • Orthodontic Department, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Activator; Patients will be treated using the Activator appliance for one and a half year	Device: Activator; This appliance is constructed in one piece to guide the position of the mandible on closure; Other Names: Andresen Appliance
Experimental: Twin Block; Patients will be treated using the Twin Block appliance for 18 months on average	Device: Twin Block; This appliance is constructed in two pieces to guide the position of the mandible on closure; Other Names: Clark's appliance
No Intervention: Control; Patients will be monitored until the last assessment times in the other groups. This group will serve as a control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Abdulmalek Majanni, DDS MSc, PhD Student in Orthodontics, University of Damascus Dental School, Damascus; Study Director: Issam Khoury, DDS MSc PhD, Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, SYRIA

Publications and helpful links

General Publications

• Aidar LA, Dominguez GC, Yamashita HK, Abrahao 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.
• 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.
• Arat ZM, Gokalp 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. doi: 10.1067/mod.2001.110245.
• 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(1):57. doi: 10.1186/s40510-014-0057-6.
• Cimic S, Badel T, Simunkovic 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.
• Clark WJ. The twin block technique. A functional orthopedic appliance system. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):1-18. doi: 10.1016/0889-5406(88)90188-6. No abstract available.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): March 19, 2019
• Study Completion (Actual): November 19, 2019

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite; Retrognathia
• Other Study ID Numbers: UDDS-Ortho-09-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No