Assessment of Treatment Efficacy Using Smile Arc Marginal Ridge Approach Versus MBT Chart Method for Bracket Positioning

Официальное название

Assessment of Treatment Efficacy Using Smile Arc Marginal Ridge Approach Versus MBT Chart Method for Bracket Positioning: A Randomized Clinical Trial

Обзор

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.

Вмешательства

• Другое Smile Arc Marginal Ridge Approach (SAMRA)
  Smile Arc Marginal Ridge Approach (SAMRA) is a new orthodontic bonding technique proposed by Dr. Dalia El Bokle where she stated that it provides more accurate orthodontic results and less time and effort needed during finished. No randomized clinical trials are done on this new approach yet so our study is the first one to test it. 0.018-inch MBT brackets will be used in our study.
• Другое MBT Chart Method
  For our comparator group MBT Chart Method will be used. Using charts during orthodontic bonding procedures is considered the gold standard. 0.018-inch brackets will be used.

Первичные конечные точки

• Orthodontic treatment results [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Number of additional archwire bending and bracket repositioning needed [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Dentistry Cairo University — Cairo

Идентификаторы

NCT: NCT06652230 · 42/7/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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