Dentoskeletal Effects of 3D-Printed Fixed Twin Block Versus MARA Appliances in Management of Skeletal Class II

Официальное название

Dentoskeletal Effects of CAD/CAM 3D-Printed Fixed Twin Block Versus MARA Appliances in the Management of Skeletal Class II Due to Mandibular Deficiency in Preadolescence: A Randomized Controlled Trial

Обзор

Objective: to evaluate the dentoskeletal effects of CAD/CAM 3D-Printed fixed twin block versus MARA appliances in the management of skeletal class II due to Mandibular Deficiency in Preadolescence Class II malocclusion is considered one of the most commonly observed problems among orthodontic patients, representing around one-third of the patients seeking orthodontic treatment reflecting a significant economic impact. Various removable and fixed functional appliances are commonly used to stimulate mandibular growth. Fixed Twin-block appliance has advantages compared with removable Twin-block and Herbst appliances. The mandibular anterior repositioning appliance is referred to as M.A.R.A. appliance. Materials and method: The study design is a randomized controlled trial in which the control group and intervention groups will be assessed as parallel groups with a 1:1:1 allocation ratio. Sixty subjects will be enrolled in this research. They will be divided equally into three groups: untreated control, MARA group and Twin block group

Вмешательства

• Устройство MARA appliance
  CAD/CAM 3D printed mandibular anterior repositioning appliance
• Устройство fixed twin block
  CAD/CAM 3D printed fixed twin block

Первичные конечные точки

• Linear Skeletal changes of the maxilla and mandible using cephalometric measurements [Срок оценки: From date of randomization until the date of first documented acceptable correction assessed up to 6 months]
• Angular skeletal changes of the maxilla and mandible using cephalometric measurements [Срок оценки: From date of randomization until the date of first documented acceptable correction assessed up to 6 months]
• Linear dental changes of the maxilla and mandible using cephalometric measurements [Срок оценки: From date of randomization until the date of first documented acceptable correction assessed up to 6 months]
• Angular dental changes of the maxilla and mandible using cephalometric measurements [Срок оценки: From date of randomization until the date of first documented acceptable correction assessed up to 6 months]
• Linear soft tissue changes of the maxilla and mandible using cephalometric measurements [Срок оценки: From date of randomization until the date of first documented acceptable correction assessed up to 6 months]
• Angular soft tissue changes of the maxilla and mandible using cephalometric measurements [Срок оценки: From date of randomization until the date of first documented acceptable correction assessed up to 6 months]

Вторичные конечные точки (5)

• Oral health quality of life questionnaire [Срок оценки: From date of randomization until the date of first documented acceptable correction assessed up to 6 months]
• Incidence of breakages and harms reported during routine or emergency visits in both groups [Срок оценки: From date of randomization until the date of first documented acceptable correction assessed up to 6 months]
• Arch perimeter and depth measurement from digital model analysis [Срок оценки: From date of randomization until the date of first documented acceptable correction assessed up to 6 months]
• Maxillary inter-canine width from digital model analysis [Срок оценки: From date of randomization until the date of first documented acceptable correction assessed up to 6 months]
• Maxillary inter-first molar width from digital model analysis [Срок оценки: From date of randomization until the date of first documented acceptable correction assessed up to 6 months]

Критерии участия

Критерии включения

• Skeletal Class II malocclusion due to mandibular retrusion.
• Overjet ≥ 6.0 mm.
• Normal or low-angle growth pattern.
• Minimum crowding in the mandibular arch.
• Undergoing circumpubertal phase of skeletal development (CVMI 2, 3, and 4)

Критерии исключения

• Clinical signs and symptoms of temporomandibular disorder.
• Systemic disease affecting bone and general growth.
• Previous orthodontic treatment
• Cleft lip or palate.
• Congenital craniofacial deformity.
• Abnormal oral habits.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of dentistry, Mansoura university — Al Mansurah

Идентификаторы

NCT: NCT07340242 · MDP.25.03.5

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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