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临床试验/NCT06652230
NCT06652230招募中不适用

Assessment of Treatment Efficacy Using Smile Arc Marginal Ridge Approach Versus MBT Chart Method for Bracket Positioning: 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8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
招募中
入组人数
30
试验地点
1
主要终点
Orthodontic treatment results

研究概览

简要总结

The goal of this randomized clinical trial is to evaluate the effect of Smile Arc Marginal Ridge Approach (SAMRA) versus MBT chart method for bracket positioning on orthodontic treatment results.

The main questions it aims to answer are:

Is there a difference in orthodontic treatment results between smile arc marginal ridge approach (SAMRA) and MBT chart method for bracket positioning?

Does SAMRA provide more accurate orthodontic results and reduce the number of archwire bendings and brackets repositioning needed during finishing?

The investigators will compare Smile Arc Marginal Ridge Approach (SAMRA) with MBT Chart Method (gold standard) to see if SAMRA provides more accurate orthodontic results and reduce the need for archwire bendings and brackets repositioning during finishing.

Participants will:

  • Undergo orthodontic treatment and divided into two groups, Group A (SAMRA) and Group B (MBT Chart Method).
  • 0.018-inch MBT brackets will be used in both groups.
  • Follow ups every 1 month will take place to change the archwires after becoming passive.
  • After leveling and alignment is completed, orthodontic treatment results, number of archwire bendings and brackets repositioning needed will be determined to see which type of intervention is better or if both provide similar results.

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
11 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Orthodontic patients aged 11-30 years old.
  • •Mild or moderate crowding not requiring tooth extraction.
  • •Full permanent dentition including fully erupted 7s not necessarily 8s.
  • •Good oral hygiene.
  • •Skeletal and dentoalveolar class I malocclusion.

排除标准

  • •Systemic disease potentially affecting the study outcome.
  • •Cleft lip and palate/syndromic patients.
  • •Any signs or symptoms of temporomandibular disorders (TMD).
  • •Previous orthodontic treatment.
  • •Pregnant females.
  • •Chronic use of medications.

研究组 & 干预措施

Smile Arc Marginal Ridge Approach (SAMRA)

Experimental

干预措施: Smile Arc Marginal Ridge Approach (SAMRA) (Other)

MBT Chart Method

Active Comparator

干预措施: MBT Chart Method (Other)

结局指标

主要结局

Orthodontic treatment results

时间窗: 6 months

Orthodontic treatment results will be assessed according to the American Board of Orthodontics Objective Grading System (ABO-OGS) using the ABO measuring gauge.

次要结局

  • Number of additional archwire bending and bracket repositioning needed(6 months)

研究者

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

Medhat Mostafa Kamal Abdelaziz

Principal Investigator

Cairo University

研究点 (1)

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