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临床试验/NCT02574117
NCT02574117已完成不适用

Corticotomy-assisted Slow Maxillary Expansion With Bone Allograft Assessed With Cone Beam Computed Tomography in Young Adults

Cairo University1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
1
主要终点
Inter-arch distance

研究概览

简要总结

Maxillary expansion was performed for adult female patients suffering from maxillary constriction with bilateral posterior cross-bite using fixed Quad-helix appliance, for about 8 months. The appliance was delivered and activated at the day of corticotomy and bone graft. The activation was made half-molar unit each side. The patient was scheduled each month to activate the appliance or reactivate if needed. Corticotomy was performed at area of maxillary 1st premolar, 2nd premolar and first molar. Cone beam computed tomography was performed, before appliance activation and corticotomy, at the end of expansion (8 months) and after finishing orthodontic treatment (average 2.5 years from start of treatment).

详细描述

Maxillary expansion was performed for adult female patients suffering from maxillary constriction with bilateral posterior cross-bite & dental arch discrepancy average 12 mm using fixed Quad-helix appliance, for about 8 months. The appliance was delivered and activated at the day of corticotomy and bone graft (demineralized freeze-dried bone allograft). The activation was made half-molar unit each side. The patient was scheduled each month to activate the appliance or reactivate if needed. Corticotomy was performed at area of maxillary 1st premolar, 2nd premolar and first molar. Cone beam computed tomography was performed at three stages.

T1 (baseline) Before appliance activation and corticotomy. T2 At the end of expansion. (about 8 months of expansion). T3 At the finishing stage of orthodontic treatment (average 2.5 years from start of treatment).

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
18 Years 至 22 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult female patients (18-22 years) suffering from maxillary constriction with bilateral posterior cross-bite.
  • Dental arch discrepancy average 12 mm.

排除标准

  • Having any given systemic disease.
  • Taking any type of medication and/or antibiotic therapy during the 3 months before the study.
  • Didn't perform previous orthodontic treatment.
  • Current or former smokers.

结局指标

主要结局

Inter-arch distance

时间窗: Change in mm from baseline before surgical procedure to first follow up at 8 months. Change in mm from first follow up at 8 months to second follow up after 2.5 years. Change in mm from baseline to second follow up after 2.5 years.

Change in mm inter arch distance from baseline before appliance activation and corticotomy till first follow up 8 months after expansion. Change in mm inter-arch distance from first follow up 8 months after expansion till second follow up 2.5 years from start of treatment after finishing orthodontic treatment. Change in mm inter-arch distance from baseline before appliance activation and corticotomy till second follow up 2.5 years from start of treatment after finishing orthodontic treatment.

次要结局

  • Change in tipping angle.(Change from baseline before surgical procedure to first follow up at 8 months. Change from first follow up at 8 months to second follow up after 2.5 years. Change from baseline to second follow up after 2.5 years.)
  • Degree of cross bite assessed by measuring mm distance between buccal cusp of the tooth in the upper arch and buccal cusp of same tooth in lower arch.(Change from baseline before surgical procedure to first follow up at 8 months. Change from first follow up at 8 months to second follow up after 2.5 years. Change from baseline to second follow up after 2.5 years.)
  • Dehiscence score.(Assessment of the score at First follow up at 8 months and at Second follow up after 2.5 years.)
  • Buccal bone thickness.(First follow up at 8 months. Second follow up after 2.5 years.)

研究者

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

Noha Ayman Ghallab

Associate Professor of Oral Medicine and Periodontology

Cairo University

研究点 (1)

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