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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change in Articular Eminence Inclination
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Class II malocclusion Skeletal class II with retruded mandibles. Old between 10-13 years Healthy TMJ Horizontal or normal growth pattern
排除标准
- •Patients who have been treated previously Patients with syndromes or congenital deformities Signs or symptoms of temporomandibular disorders.
结局指标
主要结局
Change in Articular Eminence Inclination
时间窗: 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
Change in Condylar Width
时间窗: 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
Change in Glenoid Fossa Height
时间窗: 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
Change in Condylar Height
时间窗: 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
Change in Glenoid Fossa Width
时间窗: 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
Change in Condylar Length
时间窗: 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
Change in Condylar Circumference
时间窗: 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
Change in the Anterior Joint Space
时间窗: 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
Change in the Posterior Joint Space
时间窗: 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
Change in Border Mandibular Movements
时间窗: 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)).
Change in the Superior Joint Space
时间窗: 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
Change in the Discrepancy between CO and CR
时间窗: 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))
次要结局
未报告次要终点