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临床试验/NCT05592977
NCT05592977已完成不适用

Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars Using Infra Zygomatic Mini Implants: A Prospective Clinical Trial

Future University in Egypt1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年11月9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
10
试验地点
1
主要终点
linear distalization of maxillary 1st molar.

研究概览

简要总结

There is a scarcity in the current literature regarding such appliance and its effect on distalizing the first maxillary molar in absence of the second molar. Therefore, this study was made to evaluate the effect of bilateral distalization of upper first molars in a group of patients after extraction of maxillary second Molars using infra zygomatic mini implants.

详细描述

The appliances available for distalization used to be mainly extraoral distalizing appliances which depended entirely on patient cooperation and compliance. Even after the emergence of intra-oral distalizing appliances they had adverse dentoalveolar effect such as anchorage loss and flaring of the upper anterior teeth. Thus, this study was made in order to evaluate the efficiency of our proposed appliance in the treatment of Class II patients while avoiding the adverse effects mentioned above.

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

盲法说明

Due to the nature of the study, the operator and patients can't be blinded. Blinding of the outcome assessors can be done by sealing the name of the patient in the pre and post treatment radiographs used for analysis

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Female Patients with cervical vertebra maturation index (CVMI) 5 &
  • •From quarter unit to 3\4-unit class II molar relationship.
  • •An overjet of an average 6mm.
  • •Full Set of permanent dentition except for the maxillary second molar.
  • •Favorable path of eruption for the maxillary third molar.

排除标准

  • •Medically compromised Patients.
  • •Patients under long term medications.
  • •Patients having sever periodontal disease.
  • •CVMI 3 or less
  • •Full unit class II cases

研究组 & 干预措施

Intra-oral Distalizing Appliance

Experimental

Two infra zygomatic mini-implants will be placed Bands will be cemented to upper first molars. The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars.

Orthodontic force 300 mg per side Will be delivered by Niti closed coil spring which is attached from infra zygomatic mini screw to the hook soldered to the wire framework.

干预措施: Intra-Oral Distalizing Device (Device)

结局指标

主要结局

linear distalization of maxillary 1st molar.

时间窗: Up until Class I Molar Relation (a maximum of 8 months regardless)

Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts as well as cone-beam computed tomography (CBCT) in millimetres.

Rate of maxillary 1st molar Distalization in mm/ month.

时间窗: Up until Class I Molar Relation (a maximum of 8 months regardless)

Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts with a monthly follow up in millimetres.

次要结局

  • Changes in Intermolar width in mm.(Up until Class I Molar Relation (a maximum of 8 months regardless))
  • Changes of Molar inclination in degrees.(Up until Class I Molar Relation (a maximum of 8 months regardless))

研究者

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

Hosam Abdullah Mohamed Zaza

Principle investigator

Future University in Egypt

研究点 (1)

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