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临床试验/NCT03772379
NCT03772379Unknown不适用

Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction

Cairo University0 个研究点目标入组 34 人开始时间: 2019年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
34
主要终点
Dental changes(transverse).

研究概览

简要总结

The aim of this study is to evaluate and compare the effect of rapid maxillary expansion with and without microosteoperforation in patients with skeletal maxillary constriction.Theoretically, the force generated by the activation of the Hyrax expander leads initially to the compression of the periodontal ligament, bending of the alveolar bone, and tipping of the anchor teeth. This in turn contributes to the unfavorable changes in the supporting tissues; such as root resorption, buccal crown tipping, reduction of buccal bone thickness, marginal bone loss and alveolar bone fenestration and dehiscence. In this trial, it is assumed that by reducing the cortical bone resistance, using micro-osteoperforation (MOP), the alveolar bone bending and buccal tipping that usually occur during expansion will be reduced and thus facilitating the bone expansion.

详细描述

The study consists of 2 groups that are divided divided equally and randomly.The first group will receive a tooth borne Hyrax expander supported on first premolar and first permanent molar , whereas the second group will receive the same appliance associated with microosteoperforation(MOP). The MOP will be performed on the buccal segment bilaterally along the maxilla starting from the distal of the canine till the distal of the first permanent molar. The assessment will be done using CBCT scans immediately after expansion and 6 months postretention.

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)

入排标准

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

入选标准

  • Female adolescent patients with an age range 11- 14 years.
  • Having apical constricted maxillary arch reflected by posterior cross-bite and verified through Howe's analysis on the dental study models.
  • Normal vertical growth pattern.
  • Fully erupted maxillary first premolars and first permanent molars.

排除标准

  • Previous orthodontic treatment.
  • Any congenital anomalies, systemic disease, or asymmetries that might have an influence on tooth movement.
  • Active periodontal affection or severe gingival inflammation.

研究组 & 干预措施

tooth borne hyrax expander group

Experimental

patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars .

干预措施: tooth borne hyrax expander (Device)

tooth borne hyrax expander with microosteoperforation

Experimental

patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars and microosteoperforation .

干预措施: microosteoperforation (Procedure)

结局指标

主要结局

Dental changes(transverse).

时间窗: an average1 year

it will be measured in mm on Cone beam computed tomography image using a software

Dental tipping.

时间窗: an average1 year

it will be measured in degree on Cone beam computed tomography image using a software

Alveolar bending

时间窗: an average1 year

it will be measured in degree on Cone beam computed tomography image using a software

Skeletal changes(transverse, anteroposterior and vertical)

时间窗: an average1 year

it will be measured in mm on Cone beam computed tomography image using a software

次要结局

  • Pattern of expansion(an average1 year)

研究者

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

Mennatallah Ihab Elsayed

researcher assisstant at the national research center

Cairo University

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