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临床试验/NCT06481761
NCT06481761已完成不适用

The Effectiveness of Double-slot Brackets Versus Single-slot Brackets on the Rate of Canine Retraction: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
rate of canine retraction

研究概览

简要总结

The aim of this Randomized clinical trial is to compare the efficacy of the double slot brackets compared to single slot-brackets in producing a controlled rate of upper canine retraction into premolar extraction space.

patients will be randomly divided into one of the two groups, CBCT (cone beam computed tomography) and dental models will be taken for each patient Pre-retraction and following the study completion.

The rate of retraction will be evaluated for both groups as well as Amount of canine root movement and molar anchorage loss will be also assessed.

详细描述

Eligible patients will be examined for fulfilling the inclusion criteria. All the recruited patients need extraction of upper first premolars followed by canine retraction with maximum anchorage.

The patients will be randomly allocated to one of the two groups; either Double slot brackets or single slot-brackets group.

In Double slot bracket group, Canine retraction will be made on two 0.016'' StSt (stainless steel) round wires, each in one of the slots of the double slot brackets. while in single slot-bracket group, Retraction will be made on one 0.017''×0.025'' rectangular StSt arch wire .

The patients will be seen on a monthly basis for follow up visit for reactivation of retraction to maintain constant force during the study. An impression will be taken for the patients every visit, fabricated dental models will be digitally scanned. The scanned models will be used to monitor the rate of canine retraction.

Every patient will be asked to take a CBCT image of the upper arch pre Retraction and after the completion of study duration (3 months). After data collection, assessors will carry on the measurements blindly. Statistical analysis of the data will be done and the results will be compared to evaluate the effectiveness of both techniques for canine retraction.

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)

盲法说明

Due to the nature of the intervention, neither participants nor investigators can be blinded.

入排标准

年龄范围
16 Years 至 26 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Good oral hygiene.
  • Adult Male or Female patients with an age range of 16-26 years old.
  • Full set of permanent dentition(excluding third molar).
  • Any kind of malocclusion requiring first premolar extraction and canine retraction.
  • Patients with type/pattern of crowding that allows leveling and alignment before premolar extraction

排除标准

  • History of previous orthodontic treatment.
  • Craniofacial deformity.
  • Systematic disease or administrating drugs affecting tooth movement.
  • Poor oral health.

研究组 & 干预措施

Single-slot brackets

Active Comparator

Bonding of the upper arch up to second molars with Roth prescription 0.022x.028" single slot brackets (MINI MS-American orthodontics)

干预措施: Single-slot brackets (Device)

Double-slot brackets

Experimental

Double slot brackets (SORTECH-South Orthodontic Technology) will be Bonded on the upper arch up to the second molars. The brackets are of Roth prescription & have two slots, cervical 0.018x.025" slot and incisal/occlusal 0.022x.028" slot

干预措施: Double-slot brackets (Device)

结局指标

主要结局

rate of canine retraction

时间窗: 3 months

millimeters through superimposed digital models taken for each patient monthly at the follow up visits.

次要结局

  • Amount of canine root movement(3 months)
  • Molar cusp anchorage loss(3 months)
  • Total distance moved by the maxillary canine tip(3 months)
  • the change in Maxillary canine Torque(3 months)
  • change in maxillary canine tipping(3 months)
  • The changes in maxillary canine rotation(3 months)
  • Amount of maxillary canine root resorption(3 months)

研究者

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

Raghad Mohsen Ghoneim

Principal Investigator

Cairo University

研究点 (1)

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