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临床试验/NCT03833739
NCT03833739已完成不适用

A Prospective Randomized Clinical Trial to Compare Between Two Leveling and Alignment Protocols for the Treatment of Class II Division 2 Malocclusion

Jordan University of Science and Technology1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Upper and lower incisors proclination

研究概览

简要总结

The aim of this prospective study was to compare between two different treatment modalities of class II division 2; to start treatment in upper arch first until adequate overjet is obtained or to start in the lower arch first with removable anterior bite plane in upper arch.

详细描述

Fifty four subjects with class II division 2 participated in this study. The subjects were randomly divided into two groups; Group one (28 patients): orthodontic treatment with upper arch bond up first and lower arch was bonded when 4 mm overjet was reached. The treatment continued until 0.019 x 0.025 " stainless steel wires were reached in both arches. Group 2 (26 patients): orthodontic treatment with lower arch bond up first with removable anterior bite plane in upper arch. When 0.019 x 0.025" stainless steel wire was reached, the upper arch was bonded. The treatment continued until 0.019 x 0.025" stainless steel wires were reached. Three cephalograms were taken for each patient in both groups; pretreatment (T0) , after bonding the other arch (T1) and at the end of leveling and alignment in both arches (T2). Cephalometric measurements and superimpositions were made. Skeletal and dentoalveolar treatment changes were compared within and between the 2 groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment

入排标准

年龄范围
17 Years 至 26 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 17 years and ≤ 26 years
  • Class II division 2 malocclusion.
  • Overjet (OJ) < 4 mm.
  • Overbite (OB) covering more than half of the lower incisor height.
  • Mild to moderate crowding with tooth contact displacement no more than 2 mm.
  • Good oral hygiene and healthy periodontium.

排除标准

  • Systemic health problems and medications were taken.
  • History of previous orthodontic treatment.

研究组 & 干预措施

Upper Arch Treatment First

Experimental

Intervention : using fixed orthodontic pre-adjusted edgewise appliance in the upper and lower arches.

starting treatment in the upper arch The upper ach was bonded for 28 patients and teeth alignment was started using round 0.014"NiTi arch wire. The 0.014"NiTi arch wire was placed into the slots of the brackets and tied with elastomers by figure of 8. Orthodontic treatment was continued in the upper arch with arch wire sequence of 0.014"NiTi, 0.018"NiTi, 0.016"X0.022"NiTi, 0.019"X0.025"NiTi, and 0.019"X0.025"stainless steel arch wires. The patients were followed up on a monthly basis until sufficient proclination of the upper incisors achieved to establish an overjet of at least 4 mm. After reaching the full working arch wire in lower arch (0.019" X 0.025"stainless steel wire), lateral cephalogram and study models were taken.

干预措施: Fixed appliance (Device)

Lower Arch Treatment First

Experimental

Intervention : using fixed orthodontic pre-adjusted edgewise appliance in the lower arch and anterior bite plate in the upper arch.

The lower arch was bonded after taking the pretreatment records. At the same appointment an anterior bite plate in the upper arch was delivered to prevent shearing off the mandibular incisor brackets and help in correction of anterior deep bite .After lower arch alignment and leveling in the same arch wire sequence as the other group and 0.019" X 0.025"stainless steel arch wire was reached, the anterior bite plate was removed and the upper arch was bonded. The same arch wire sequence was used in the upper arch as was used in the lower arch. When the full working arch wire (0.019" X 0.025"stainless steel arch wire) was reached in the upper arch, study models and lateral cephalogram were taken.

干预措施: Fixed appliance (Device)

结局指标

主要结局

Upper and lower incisors proclination

时间窗: 2 years

Cephalometric analysis. Treatment changes in the values for upper and lower incisors in degrees, Upper incisor /Maxillary plane in degrees and lower incisors/Mandibular plane in degrees.

次要结局

  • Pain perception(2 years)
  • Duration of treatment(2 years)

研究者

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

Mahmoud abuaysheh

Principal Investigator - Master student

Jordan University of Science and Technology

研究点 (1)

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