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临床试验/NCT04468295
NCT04468295Unknown不适用

Evaluation of the Rate of Maxillary En-masse Retraction Using 0.018-inch Versus 0.022-inch Slot Brackets in Adult Patients With Maxillary Dentoalveolar Protrusion: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 22 人开始时间: 2020年9月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
22
主要终点
Retraction Rate

研究概览

简要总结

The study compares the rate of en-masse retraction using 0.018-inch versus 0.022-inch slot orthodontic bracket systems in adult patients with maxillary dentoalveolar protrusion.

详细描述

  • Proper examination of the oral structures is needed to identify caries, fracture or missing teeth.
  • Full set of records ( study models, lateral cephalometric radiographs, photos) will be taken for every patient as part of the routine procedure for treatment of patients in the outpatient clinic of the Orthodontic Department, Cairo University.
  • In intervention group: Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018-inch (American Orthodontics).
  • In comparator group: Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.022-inch (American Orthodontics).
  • Levelling and alignment in both groups with wire sequence: Ni-Ti (0.014,0.016, 0.016×0.022)
  • Steel ligation of maxillary (2nd premolar, 1st molar and 2nd molar) for anchorage.
  • Extraction of maxillary 1st premolars.
  • Impression will be taken, poured in plaster from which digital models will be fabricated before beginning of en-masse retraction (the baseline model).
  • Lateral cephalometric and periapical radiographs will be taken before starting retraction.
  • En-masse retraction will be done using 0.017x0.025 TMA T-Loop10 in both groups, the loops will be reactivated monthly.
  • Alginate impressions will be taken every month, that will be scanned to obtain digital models to assess the rate of retraction for 6 months.
  • After 6 months, last obtained digital model will be evaluated for assessment of anchorage loss, and Lateral cephalometric and periapical radiographs will be taken to assess changes in the anterior teeth inclinations and apical root resorption respectively.
  • The patients' treatment will be completed as indicated for them.

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
Double (Participant, 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

  • •Maxillary dentoalveolar protrusion cases that require upper first premolars extraction.
  • •Full permanent dentition (not necessitating third molars).
  • •Good oral hygiene.

排除标准

  • •Patients having systemic diseases or on medications that would affect tooth movement.
  • •Active periodontal disease or obvious bone loss in maxillary arch.
  • •Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).
  • •Previous orthodontic treatment.
  • •Missing teeth.

研究组 & 干预措施

0.018-inch slot orthodontic bracket system

Experimental

En-masse retraction using frictionless mechanics with 0.018-inch slot orthodontic bracket system.

干预措施: Bonding (Procedure)

0.018-inch slot orthodontic bracket system

Experimental

En-masse retraction using frictionless mechanics with 0.018-inch slot orthodontic bracket system.

干预措施: Leveling and alignment (Procedure)

0.018-inch slot orthodontic bracket system

Experimental

En-masse retraction using frictionless mechanics with 0.018-inch slot orthodontic bracket system.

干预措施: Extraction (Procedure)

0.018-inch slot orthodontic bracket system

Experimental

En-masse retraction using frictionless mechanics with 0.018-inch slot orthodontic bracket system.

干预措施: Retraction (Procedure)

0.018-inch slot orthodontic bracket system

Experimental

En-masse retraction using frictionless mechanics with 0.018-inch slot orthodontic bracket system.

干预措施: Digital models (Procedure)

0.018-inch slot orthodontic bracket system

Experimental

En-masse retraction using frictionless mechanics with 0.018-inch slot orthodontic bracket system.

干预措施: measurement (Procedure)

0.022-inch slot orthodontic bracket system

Active Comparator

En-masse retraction using frictionless mechanics with 0.022-inch slot orthodontic bracket system.

干预措施: Bonding (Procedure)

0.022-inch slot orthodontic bracket system

Active Comparator

En-masse retraction using frictionless mechanics with 0.022-inch slot orthodontic bracket system.

干预措施: Leveling and alignment (Procedure)

0.022-inch slot orthodontic bracket system

Active Comparator

En-masse retraction using frictionless mechanics with 0.022-inch slot orthodontic bracket system.

干预措施: Extraction (Procedure)

0.022-inch slot orthodontic bracket system

Active Comparator

En-masse retraction using frictionless mechanics with 0.022-inch slot orthodontic bracket system.

干预措施: Retraction (Procedure)

0.022-inch slot orthodontic bracket system

Active Comparator

En-masse retraction using frictionless mechanics with 0.022-inch slot orthodontic bracket system.

干预措施: Digital models (Procedure)

0.022-inch slot orthodontic bracket system

Active Comparator

En-masse retraction using frictionless mechanics with 0.022-inch slot orthodontic bracket system.

干预措施: measurement (Procedure)

结局指标

主要结局

Retraction Rate

时间窗: 6 months

The rate of en-masse retraction of the anterior teeth

次要结局

未报告次要终点

研究者

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

Omar Abdelaziz

Principal Investigator

Cairo University

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