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

Primary Purpose

Malocclusion, Angle Class II, Retrognathism, TMJ

Status

Completed

Phase

Not Applicable

Locations

Syrian Arab Republic

Study Type

Interventional

Intervention

Activator

Twin Block

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class II

Eligibility Criteria

10 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Orthodontic Department, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Activator

Twin Block

Control

Arm Description

Patients will be treated using the Activator appliance for one and a half year

Patients will be treated using the Twin Block appliance for 18 months on average

Patients will be monitored until the last assessment times in the other groups. This group will serve as a control group

Outcomes

Primary Outcome Measures

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

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

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

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

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

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

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

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

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

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

Change in Border Mandibular Movements

Border mandibular movements will be measured on the axiograph apparatus (called Arcosdigma(R)).

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))

Secondary Outcome Measures

Full Information

NCT ID

NCT03645343

First Posted

August 22, 2018

Last Updated

January 31, 2020

Sponsor

Damascus University

1. Study Identification

Unique Protocol Identification Number

NCT03645343

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

June 15, 2018 (Actual)

Primary Completion Date

March 19, 2019 (Actual)

Study Completion Date

November 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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 : Activator Group Twin block Group 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

Detailed Description

The main purposes of this project are: to evaluate the remodeling effects that would take place in the bone structures of the temporomandibular joint (TMJ) during functional treatment. to evaluate the possible change that may occur in mandibular movements following functional treatment. to evaluate the possible change in the spatial relationship between centric occlusion (CO) and centric relation (CR) following functional treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malocclusion, Angle Class II, Retrognathism, TMJ

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Activator

Arm Type

Active Comparator

Arm Description

Patients will be treated using the Activator appliance for one and a half year

Arm Title

Twin Block

Arm Type

Experimental

Arm Description

Patients will be treated using the Twin Block appliance for 18 months on average

Arm Title

Control

Arm Type

No Intervention

Arm Description

Patients will be monitored until the last assessment times in the other groups. This group will serve as a control group

Intervention Type

Device

Intervention Name(s)

Activator

Other Intervention Name(s)

Andresen Appliance

Intervention Description

This appliance is constructed in one piece to guide the position of the mandible on closure

Intervention Type

Device

Intervention Name(s)

Twin Block

Other Intervention Name(s)

Clark's appliance

Intervention Description

This appliance is constructed in two pieces to guide the position of the mandible on closure

Primary Outcome Measure Information:

Title

Change in Glenoid Fossa Height

Description

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

Time Frame