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临床试验/NCT06209086
NCT06209086已完成不适用

Evaluation of the Dentoskeletal Effects of Skeletal Anchored Versus Incisal Capped Twin Block Appliance in the Treatment of Class II Malocclusion

Mansoura University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2021年5月12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
26
试验地点
2
主要终点
dentoskeletal effects of skeletal anchored versus incisal capped twin block appliance in the correction of skeletal class II malocclusion

研究概览

简要总结

: the purpose of this study was to evaluate the dento-skeletal effects of the mini-implant supported Twin Block versus the incisal capped appliance in the treatment of skeletal class II patients with mandibular retrognathism.

Methods: Twenty patients with skeletal class II mandibular retrusion were included in the study. They were recruited with a random and equal allocation into 2 groups. The first group was treated with incisal capped TB without skeletal anchorage. The second group were treated with mini-implant supported TB. The mini-implants were inserted in the inter-radicular region between the mandibular second premolar and first molar. Intra-oral elastics were attached from the mini-implant to the wire hook in the canine region of the lower part of the TB and they were changed every 24 hrs. 100 to 150 gm of force was applied. Cephalometric radiographs were acquired at the beginning (T1) and end of treatment (T2). The paired-samples and independent-samples t-tests were used to evaluate and compare the changes within groups and between groups, respectively.

详细描述

Twenty patients with skeletal class II mandibular retrusion were included in the study. They were recruited with a random and equal allocation into 2 groups. The first group was treated with incisal capped TB without skeletal anchorage. The second group were treated with mini-implant supported TB

Appliance construction:

  1. Bite registration
  • First, the administrator measured the overjet using calibrated poly gauge from the incisal edge of the most protruded upper incisor to the facial surface of the lower central incisor.
  • Then, a wax bite was done using the Exacto bite or Projet Bite Gauge (12) with the addition of softened horseshoe wafer of medium hard wax for easy registration of the bite. The mandible was anteriorly positioned to make an edge-to-edge relationship parallel to the functional occlusal plane. At the same time, the posterior vertical separation between arches was with an adequate width between 4-5 mm. The excess was removed along the gingiva, retromolar region and on the palatal tissue if found.
  • During bite registration, making sure the upper and lower mid lines of the patient were the same as in his original distal occlusion as long as there was no functional shift of the mandible.
  1. Design of the appliance A-modified twin block The incisal capped Twin Block, which was used for the first group composed of two parts. The upper part had labial bow over labial surface of upper anterior teeth using Adam and ball clasps for retention.

The lower part included ball clasp between lower anterior teeth and Adam clasp on lower first premolar with the additional modifications:

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
9 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • early permanent dentition (ages 9 to 14)
  • mandibular retrusion-related class II skeletal deformity
  • overjet more than 4mm.

排除标准

  • systemic diseases
  • congenital craniofacial deformity
  • cleft lip or palate
  • unusual habits
  • previous orthodontic treatment.

结局指标

主要结局

dentoskeletal effects of skeletal anchored versus incisal capped twin block appliance in the correction of skeletal class II malocclusion

时间窗: 11 months

the study include 20 patients with skeletal class II malocclusion who were treated with incisal capped and skeletal anchored twin block advancement of mandible with controlling the position of lower incisors in the second group

次要结局

未报告次要终点

研究者

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

Asmaa Elabd

teaching assistant - orthodontic department

Mansoura University

研究点 (2)

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