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临床试验/NCT03635463
NCT03635463Unknown不适用

Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency: A Randomized Controlled Trial

Cairo University0 个研究点目标入组 30 人开始时间: 2018年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
主要终点
enhancing mandibular skeletal growth

研究概览

简要总结

The aim of this study is to evaluate the treatment effects of conventional twin block appliance versus modified twin block appliance in the treatment of patients in growing stage having skeletal class II division 1 with mandibular deficiency.

详细描述

in this randomized controlled trail there are 2 groups , the first group will receive modified twin block appliance ,in the second group will receive conventional twin block appliance . the follow up period will be 9 months till mandibular growth occur . the assessment will be through a questionnaire on the number of hours the appliance is worn each day , and another questionnaire assessing the difficulty of speech and aesthetics . Also by, photographs, x-rays and study models preoperative and post operative.

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 (Participant)

盲法说明

double blinded( participant and outcome assessor)

入排标准

年龄范围
9 Years 至 12 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Skeletal Class II relationship (ANB > 4°).
  • Mandibular retrognathy (SNB < 78°).
  • Overjet ≥ 5 mm.
  • Minimal crowding in dental arches (≤4 mm).
  • Class II molar relation.
  • Growing female patients.
  • Patients with CMV3 maturation stage of the cervical verbrae.

排除标准

  • No history of orthodontic treatment either prior to or during functional Appliance therapy.
  • Posterior cross bites or severe maxillary transverse deficiency.
  • Severe facial asymmetry determined by clinical or radiographical examination.
  • Poor oral hygiene.
  • Systemic diseases that may affect the orthodontic treatment results.
  • Patients past their peak growth spurt.

研究组 & 干预措施

twin block appliance

Experimental

this group will receive conventional twin block appliance and followed up every month for 9 months.

干预措施: twin block appliance (Device)

modified twin block appliance group

Experimental

modified twin block appliance group , this group will receive the modified appliance and followed up every month for 9 months

干预措施: modified twin block appliance (Device)

结局指标

主要结局

enhancing mandibular skeletal growth

时间窗: 9 months

it will be assessed by measuring the incremental growth by quick ceph (mm)

次要结局

  • Improvement of soft tissue profile(9 months)
  • Patient's compliance(9 months)
  • dentoalveolar changes(9 months)

研究者

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

Heba Yehia

assistant lecturer

Cairo University

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