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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03645343
Enrollment
66
Registered
2018-08-24
Start date
2018-06-15
Completion date
2019-11-19
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Angle Class II, Retrognathism, TMJ

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 : 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

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

Interventions

DEVICEActivator

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

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

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 13 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Glenoid Fossa HeightT1: at one day before the commencement of treatment; T2: after 12 months of treatmentGlenoid 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 WidthT1: at one day before the commencement of treatment; T2: after 12 months of treatmentGlenoid 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 InclinationT1: at one day before the commencement of treatment; T2: after 12 months of treatmentArticular 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 HeightT1: at one day before the commencement of treatment; T2: after 12 months of treatmentCondylar 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 WidthT1: at one day before the commencement of treatment; T2: after 12 months of treatmentCondylar 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 LengthT1: at one day before the commencement of treatment; T2: after 12 months of treatmentCondylar 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 CircumferenceT1: at one day before the commencement of treatment; T2: after 12 months of treatmentCondyle 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 SpaceT1: at one day before the commencement of treatment; T2: after 12 months of treatmentAnterior 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 SpaceT1: at one day before the commencement of treatment; T2: after 12 months of treatmentSuperior 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 SpaceT1: at one day before the commencement of treatment; T2: after 12 months of treatmentPosterior 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 MovementsT1: at one day before the commencement of treatment; T2: after 12 months of treatmentBorder mandibular movements will be measured on the axiograph apparatus (called Arcosdigma(R)).
Change in the Discrepancy between CO and CRT1: at one day before the commencement of treatment; T2: after 12 months of treatmentCO-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))

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026