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临床试验/NCT05647720
NCT05647720已完成不适用

Effect of Maxillary Third Molar Extraction vs Non-extraction on Distalization of First Molars in a Group of Adolescent Patients Using Infra-Zygomatic Gear Distalizer: A Randomized Clinical Trial

Future University in Egypt1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年2月28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
22
试验地点
1
主要终点
distalization amount of maxillary firs molars at the crown and root levels

研究概览

简要总结

There is a scarcity in literature regarding the influence of maxillary third molar on distalization . This study aimed to compare the influence of unerupted maxillary third molars and their extraction on the bilateral distalization of upper first molars using the infra-zygomatic gear distalizer

详细描述

Maxillary molar distalization is one of the non-extraction modalities for treating class II malocclusion. When distalizing maxillary molars In adults, it is not a problem to extract fully erupted third molars, and it may even be suggested that the extraction site may accommodate distalization. On the contrary, adolescents usually have unerupted third molars with partially formed roots, rendering the surgical extraction more difficult and traumatic. The necessity of surgically extracting upper third molar buds before distalization remains questionable. Therefore, this study was conducted to three-dimensionally assess the impact of maxillary third molar presence on distalizing maxillary molars in adolescent patients having Class II malocclusion.

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 (Outcomes Assessor)

盲法说明

Only the outcome assessors will be blind. The patients name will be sealed from the pre- and post-radiographs and study models. Then two assessors will carry out, blindly and independently, the measurements and analysis of the study

入排标准

年龄范围
16 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Adolescent patients aged 16-19 years
  • •skeletal Class I
  • •bilateral Class II molar relationship. defined by at least an end-to-end molar relationship.
  • •normal vertical growth pattern.
  • •full permanent dentition with unerupted upper third molars.

排除标准

  • •skeletal Class II or Class III relationship.
  • •past orthodontic treatment.
  • •poor oral hygiene.
  • •Increased vertical dimension.

研究组 & 干预措施

Third molar extraction group

Experimental

After surgical extraction of unerupted upper third molars, the maxillary first molars were distalized using the infra-zygomatic gear distalizer, which is anchored to infra-zygomatic mini-implants inserted in the infra-zygomatic crest.

干预措施: Distalization combined with upper third molars extraction (Procedure)

Third molar presence group

Experimental

Without extraction of unerupted upper third molars, the maxillary first molars were distalized using the infra-zygomatic gear distalizer, which is anchored to infra-zygomatic mini-implants inserted in the infra-zygomatic crest.

干预措施: Distalization without upper third molars extraction (Procedure)

结局指标

主要结局

distalization amount of maxillary firs molars at the crown and root levels

时间窗: From pre to post distalization (an average of 8 months)

Anteroposterior changes in the position of maxillary first molars assessed on digitized models and cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes(measured in mm)

次要结局

  • Tipping of maxillary third molar(From pre- to post-distalization (an average of 8 months))
  • Tipping of maxillary first molar(From pre- to post-distalization (an average of 8 months))
  • Vertical position of maxillary first molar(From pre- to post-distalization (an average of 8 months))
  • Molar rotation(From pre- to post-distalization (an average of 8 months))
  • Vertical position of maxillary third molar(From pre- to post-distalization (an average of 8 months))
  • Vertical position of upper incisors(From pre- to post-distalization (an average of 8 months))
  • Inter molar width(From pre- to post-distalization (an average of 8 months))
  • Anteroposterior position of upper incisors(From pre- to post-distalization (an average of 8 months))
  • Rate of maxillary first molar Distalization(From pre- to post-distalization (an average of 8 months))
  • Tipping of maxillary second molar(From pre- to post-distalization (an average of 8 months))
  • upper incisors torque(From pre- to post-distalization (an average of 8 months))
  • Anteroposterior changes of upper first and second premolars(From pre- to post-distalization (an average of 8 months))

研究者

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

Nadeen Hafez

Principal investigator

Future University in Egypt

研究点 (1)

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