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临床试验/NCT06130748
NCT06130748进行中(未招募)不适用

Effectiveness of Two Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood: A Randomized Control Trial.

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年4月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
24
试验地点
1
主要终点
Skeletal maxillary expansion To compare the amount of skeletal expansion pre and post expansion

研究概览

简要总结

The study aiming at evaluation of the Skeletal and Dento-alveolar expansion in adult patents using Two Mini-screws Supported Hyrax compared with untreated control group.

详细描述

Methodology:

  • Basic orthodontic record will be taken.
  • impression with bands on upper first molars will be taken.
  • Two eyelets will be soldered to the body of the hyrax appliance (size 10, Dentaurum, Germany).
  • CBCT will be taken while patient wearing 1 mm thickness vacuum on the lower arch to dis-occlude both arches.
  • Delivery, check the retention and fitness of the appliance.
  • Cementation of the appliance using band cement(compomer).
  • Using 3M contra-angle driver, the screws (Tomas screw size 10, Dentaurum, Germany) will be loaded and inserted.
  • Activation of the appliance by opening it two turns immediately, followed by two turns everyday till cross bite correction or appearance of midline diastema.
  • Closure of the device, and leave the appliance in-situ for five months as a retention.
  • Post-expansion CBCT will be taken and continue fixed orthodontic treatment. Outcome: skeletal and dento-alveolar expansion will be evaluated

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Unilateral or bilateral Dental posterior cross-bite
  • •Skeletal Maxillary constriction
  • •Male and female patients.
  • •Chronological age (18-30 years).
  • •Mid-palatal suture maturation (Grade C,D ) according to F Angileri classification
  • •Good oral hygiene.
  • •No craniofacial anomalies or syndromes

排除标准

  • •Scissor-bite
  • •Orthodontically-treated
  • •functional cross bite due to premature occlusal contact
  • •patients with a syndrome
  • •cleft patients

研究组 & 干预措施

Hybrid Hyrax

Experimental

Device: Hybrid hyrax these patents will be treated using Two mini-screws supported hybrid hyrax

Other Names:

• MARPE(miniscrews-assisted rapid palatal expander)

干预措施: Hybrid Hyrax (Device)

Untreated control group

No Intervention

Ethically ,these patents will be treated at the end of the study using the same appliance used for the experimental group

结局指标

主要结局

Skeletal maxillary expansion To compare the amount of skeletal expansion pre and post expansion

时间窗: the outcome will be assessed five months post-expansion

To compare the amount of skeletal expansion using linear and angular measurements and the expansion pattern of mid-palatal suture extracted from cone beam computed tomography pre and post expansion

次要结局

  • Dento-alaveolar expansion(the outcome will be assessed five months post-expansion)

研究者

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

abdullah mohammed ali al-thalabi

Master Degree student ,Faculty of Dentistry ,Cairo university.

Cairo University

研究点 (1)

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