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临床试验/NCT05963438
NCT05963438已完成不适用

Comparison Of En-Masse Retraction With Two-Step Retraction Using Mini-Implant As Anchorage - A Randomized Controlled Trial

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
To compare sagittal, vertical and dental dimensions following en-masse retraction with two-step retraction using mini-implants as anchorage.

研究概览

简要总结

This Randomized Control Trial will be conducted to compare the effects of en-masse retraction to two- steps retraction on sagittal, vertical and dental dimensions using mini-implant as anchorage.

详细描述

Extractions of teeth are the commonest approach in treating orthodontic problems. There is several extraction protocol commonly employed in the orthodontic correction of class II malocclusion ranging from the extraction of two premolars (20.2%) to four premolars (42.9%).

Retraction of anterior teeth followed by the extraction of premolars requires anchorage to restrict the mesial movement of posterior teeth. Anchorage control is a major factor in achieving successful orthodontic treatment and it can be achieved by variety of appliances, of which titanium screws have been considered as an absolute source of anchorage in orthodontics treatment. The anchorage reinforced from mini-implant is helpful in minimizing anchorage loss and accepted heavy traction forces.

Retraction of anterior teeth can be achieved either by en-masse retraction, moving all the six anterior teeth together in a single step or by two-step retraction, separately retract canines in first step followed by retracting the four anteriors in the second step.

This Randomized Control Trial will be conducted to compare the effects of en-masse retraction to two- steps retraction on sagittal, vertical and dental dimensions using mini-implant as anchorage. 80 patients will be included in this study after meeting the eligibility criteria. Each group will contain 40 patients.

The patients will be divided in two groups i.e. two-step retraction group (control group) and en-masse group (experimental group), through software generated randomization table.

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 (Participant)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Both male and female patients with age of 18- 25 years.
  • Cases treated with upper first premolars extractions.
  • Cases having class II molar relation which is mesiobuccal cusp of maxillary first permanent molar occludes anterior to the buccal groove of mandibular first molar on both sides as assessed clinically.
  • 4. Overjet > 5mm and < 12mm as assessed clinically.
  • Cases with no remaining growth as assessed by cervical vertebrae maturation stages (cvm) ≥4 on lateral cephalometric radiograph .
  • 6. Cases with no congenitally missing teeth (excluding third molars).

排除标准

  • 1. Long term use of systemic corticosteroids, calcium channel blockers & anti-inflammatory drugs.
  • 2. Cases with syndromes like cleft lip and palate as assessed clinically.
  • Cases in which active growth is still taking place as assessed by cervical vertebrae maturation stages (cvm) ≤ 3 on lateral cephalometric radiograph.
  • 4. Radiographic evidence of bone loss.
  • Periodontal disease as assessed clinically.

结局指标

主要结局

To compare sagittal, vertical and dental dimensions following en-masse retraction with two-step retraction using mini-implants as anchorage.

时间窗: Pretreatment lateral cepalogram will be taken at time of enrolment (T1) and post-treatment lateral cephalogram taken after 12 months of orthodontic treatment (T2).

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

Anam Sattar

Senior Registrar

Dow University of Health Sciences

研究点 (1)

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