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临床试验/NCT06020183
NCT06020183进行中(未招募)不适用

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

Cairo University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年9月2日最近更新:
适应症

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
2
主要终点
Skeletal maxillary expansion

研究概览

简要总结

This study aims to evaluate the Skeletal and Dento-alveolar expansion in adult patents using Four Mini-screws Supported Hyrax in compare with untreated control group.

详细描述

Aim of the study: To evaluate the Effectiveness of Four Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood

Methodology:

  • Essential record for orthodontic treatment will be taken.
  • impression with bands on upper first molars will be taken.
  • Four 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.
  • The appliance will be cemented 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

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
  • Mid-palatal suture maturation(Grade A.B,E) according to F Angileri classification

结局指标

主要结局

Skeletal maxillary expansion

时间窗: 5 months interval between pre and post-expansion

To compare the amount of skeletal expansion pre and post expansion

次要结局

  • Dento-alaveolar expansion(5 months interval between pre and post-expansion)

研究者

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

alzubair osman salih

Master Degree student ,Faculty of Dentistry ,Cairo university.

Cairo University

研究点 (2)

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