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临床试验/NCT07687927
NCT07687927已完成不适用

Dentoskeletal and Condylar Evaluation of Skeletal Class II Malocclusion by Fixed Twinblock Appliance Versus Conventional Twin Block Appliance Cone Beam Computed Tomography Study

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Change in Sagittal Skeletal Relationship (ANB Angle)

研究概览

简要总结

This study compares two types of dental appliances a fixed Twin Block appliance and a conventional (removable) Twin Block appliance used to treat a bite problem called skeletal Class II malocclusion in growing children and teenagers. In this condition, the lower jaw is positioned further back than the upper jaw. Both appliance types work by guiding the lower jaw forward during growth. The study uses 3D imaging (cone beam computed tomography, or CBCT) before and after treatment to measure how each appliance affects the bones of the jaw, the teeth, the soft tissue profile of the face, and the jaw joint (temporomandibular joint). The goal is to determine whether the fixed or the conventional version of the appliance produces better treatment outcomes.

详细描述

This comparative clinical study evaluates the skeletal, dentoalveolar, soft-tissue, and condylar/temporomandibular joint (TMJ) effects of fixed versus conventional Twin Block appliances in growing patients diagnosed with skeletal Class II malocclusion due to mandibular retrognathia. Participants were allocated to receive treatment with either a fixed or a conventional (removable) Twin Block appliance. Pre-treatment and post-treatment cone beam computed tomography (CBCT) scans were obtained to assess sagittal jaw relationships, mandibular advancement, dentoalveolar changes (including overjet and overbite correction), soft-tissue profile changes, and condylar position/remodeling within the glenoid fossa, including TMJ disc space measurements. Outcomes between the two appliance groups were compared to evaluate differences in skeletal and dental effects, as well as any differences in condylar/TMJ adaptation associated with each appliance design.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
11 Years 至 15 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Growing male patients (as judged from clinical examination and confirmed later by (CVM)
  • Skeletal class II with retrognathic mandible.
  • Healthy compliant and motivated patient.
  • No Previous orthodontic treatment.
  • No Severe facial asymmetry determined by clinical or radiographic examination.
  • No Systemic diseases that may affect the treatment results.
  • No tmj disorders.

排除标准

  • Previous orthodontic treatment.
  • Poor oral hygiene.
  • Severe facial asymmetry determined by clinical or radiographic examination.
  • Systemic disease that may affect the treatment results.
  • TMJ disorders.

结局指标

主要结局

Change in Sagittal Skeletal Relationship (ANB Angle)

时间窗: Measured at baseline (pre-treatment) and at the end of active treatment (approximately 12-18 months, based on actual treatment duration)

Measured using cone beam computed tomography (CBCT), the ANB angle reflects the anteroposterior relationship between the maxilla and mandible. Pre-treatment and post-treatment values will be compared between the fixed and conventional Twin Block appliance groups to assess skeletal correction of Class II malocclusion.

次要结局

  • Change in Sagittal Skeletal Relationship (ANB Angle)(Measured at baseline (pre-treatment) and at the end of active treatment (approximately 12-18 months, based on actual treatment duration))
  • Change in Condylar Position and TMJ Disc Space(Measured at baseline (pre-treatment) and at the end of active treatment (approximately 12-18 months, based on actual treatment duration))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omneya mohamed abo el yazeed

M.Sc. Candidate, Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University

Al-Azhar University

研究点 (1)

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