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Completed

NCT Number: NCT03645343

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

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

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Key information

Conditions

Malocclusion, Angle Class II Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Malocclusion Mandibular Diseases Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Retrognathia Retrognathism Stomatognathic Diseases Stomatognathic System Abnormalities TMJ Tooth Diseases

Age range

10 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthodontic Department, University of Damascus Dental School

Damascus, DM20AM18, Syria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Activator

Device

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

Other names: Andresen Appliance

Twin Block

Device

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

Other names: Clark's appliance

Primary outcomes

  1. Change in Glenoid Fossa Height

    Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment

    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

  2. Change in Glenoid Fossa Width

    Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment

    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

  3. Change in Articular Eminence Inclination

    Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment

    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

  4. Change in Condylar Height

    Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment

    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

  5. Change in Condylar Width

    Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment

    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

  6. Change in Condylar Length

    Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment

    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

  7. Change in Condylar Circumference

    Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment

    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

  8. Change in the Anterior Joint Space

    Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment

    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

  9. Change in the Superior Joint Space

    Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment

    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

  10. Change in the Posterior Joint Space

    Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment

    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

  11. Change in Border Mandibular Movements

    Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment

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

  12. Change in the Discrepancy between CO and CR

    Time frame: T1: at one day before the commencement of treatment; T2: after 12 months of treatment

    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))

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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