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

Damascus University

Status: Completed

Conditions: Malocclusion, Angle Class II; Retrognathism; TMJ

Treatments: Device: Twin Block; Device: Activator

Study type: Interventional

Funder types: Other

Identifiers

NCT03645343

UDDS-Ortho-09-2018

Details and patient eligibility

About

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

Full 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

Enrollment: 66 patients

Sex: All

Ages: 10 to 13 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 3 patient groups

Activator

Active Comparator group

Description:

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

Treatment:

Device: Activator

Twin Block

Experimental group

Description:

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

Treatment:

Device: Twin Block

Control

No Intervention group

Description:

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