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临床试验/NCT05605652
NCT05605652进行中(未招募)不适用

Evaluation of Leveling and Alignment of Maxillary Anterior Teeth Assisted With Micro-osteoperforations:A Comparative Clinical Study.

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年6月1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
28
试验地点
1
主要终点
• Overall time needed to complete leveling and alignment of maxillary anterior segment

研究概览

简要总结

The aim of the study will be directed to evaluate the effect of micro-osteoperforation on orthodontic tooth movement during leveling and alignment of the maxillary anterior teeth.

详细描述

The current study will be conducted on a group of orthodontic patients attending the out patients clinic, Orthodontic Department, Faculty of Dental Medicine (Boys), AL- Azhar University, Cairo

The patient will be randomly assigned into two equal groups:

  1. Experimental group: Flapless micro-osteoperforations will be performed interproximally on the alveolar bone equidistant between upper right canine to upper left canine at every interdental alveolar bone except at the midline

alveolar bone to prevent trauma to the soft tissue frenum before placing the initial leveling archwire. 2. Control group: leveling and alignment will be commenced without micro- osteoperforations.

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
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Class 1 skeletal pattern with normal facial proportions.
  • •Patients with age range between 13 -19 years.
  • •Moderate crowding of maxillary anterior region assessed by Little Irregularity Index (LII) that require treatment with fixed appliance using non extraction approach.
  • •All permanent teeth erupted (excluding 3rd molars).
  • •No previous orthodontic treatment.
  • •Good oral hygiene with no previous periodontal surgery.

排除标准

  • •Transverse and/or vertical skeletal dysplasia or craniofacial malformation.
  • •Retained primary or missing permanent teeth in the maxillary anterior area.
  • •Poor oral hygiene
  • •Present or history of periodontal diseases.
  • •Physical or mental disability.
  • •Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement.

研究组 & 干预措施

Control group

No Intervention

leveling and alignment will be commenced without micro- osteoperforations

Experimental group

Experimental

Flapless micro-osteoperforations will be performed interproximally on the alveolar bone equidistant between upper right canine to upper left canine at every interdental alveolar bone except at the midline

alveolar bone to prevent trauma to the soft tissue frenum before placing the initial leveling archwire.

干预措施: microosteoperforations (Procedure)

结局指标

主要结局

• Overall time needed to complete leveling and alignment of maxillary anterior segment

时间窗: 2months -6months

• Overall time needed to complete leveling and alignment of maxillary anterior segment was calculated by the number of days between day of inserting the 1st archwire and at the end of the leveling and alignment stage.

• Alignment progress was evaluated on 3D digital model taken before inserting the 1st archwire and then at all subsequent visits using (LII).

时间窗: 2months-6months

• Alignment progress was evaluated on 3D digital model taken before inserting the 1st archwire and then at all subsequent visits using (LII).

• Alignment improvement percentage

时间窗: 2months -6months

• Alignment improvement percentage was calculated by dividing the amount of change in the LII value at a specific time point (calculated by subtracting the LII value at T1, T2, or T3 from the LII value at T0) by LII value at T0.

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 Mohamed abd elsalam abo donia

Omar Abodonia

Al-Azhar University

研究点 (1)

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