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临床试验/NCT00688233
NCT00688233Unknown1 期

Phase 1 Effect of the Innovated Seifi's Functional Appliance on the Skeletal and Dentoalveolar Changes of Class II/Division 1, Deep Bite Cases

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
1 期
入组人数
20
试验地点
1
主要终点
Overjet and Overbite

研究概览

简要总结

For improving the appearance of protruded upper front teeth when lower front teeth may touch palatal mucosa or have proximity to that; the innovated Seifi's Functional Appliance may be used.

详细描述

Records will be obtained for each patient by the same operator before treatment and at the end of treatment. The appliance in this study is designed by Prof. Seifi and will be constructed by a well trained technician in the orthodontic laboratory of shahid Beheshti School of dentistry under the supervision of the operator. The appliance consists of a jack screw in the midpalatal region plus two Adams' clasps on the upper 1st molars and four Kimia clasps on the buccal embrasure of the upper deciduous molars or premolars. For the mandibular portion there is an incisal clasp and incisors are capped by acrylic.

The participants will be advised to use the appliance 24 hours per day except for meal times and when brushing the teeth or reading Farsi or English in class room.

Each patient will pay his/her first recall visit to the orthodontic department one week after the appliance delivery and will be instructed to turn the maxillary expansion jack screw 1:4 turn twice a week to achieve coordination of the upper and lower arches in the transverse dimension. The patients will be evaluated over one month intervals and necessary adjustments were made.

All cephalometric records, before and after treatment, will be coded and analyzed by a second party and the ultimate results and evaluations will be made.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age between 8 - 12 years old
  • Class Π division 1 malocclusion (ANB>4)
  • Increased over jet (>4mm)
  • Increased overbite (>4mm)

排除标准

  • History of previous orthodontic treatment
  • Evidence of craniofacial syndromes

结局指标

主要结局

Overjet and Overbite

时间窗: 2-6 month depending on the amount of OJ and OB and the patient compliances

次要结局

  • sagittal and vertical cephalometric measurements(before-after)

研究者

研究点 (1)

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