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Идёт набор NCT05743127

3D-Printed Versus Laboratory-Fabricated Hyrax Expanders

Без фазы С лечением Maxillary Expansion

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 3D-Printed Hyrax Expander, Conventional Laboratory Fabricated Hyrax Expander.
Кому может быть актуально
Состояния в реестре: Maxillary Expansion. Базовые параметры: 8 лет — 13 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

3D-Printed Versus Laboratory-Fabricated Hyrax Expanders: A Randomized Controlled Clinical Trial

Обзор

Maxillary expanders are orthodontic appliances that are commonly used to expand the upper jaw. The purpose of this study will be to compare the effects produced by two different maxillary expanders in children 8-13 years old. The first type of expander is made by hand in an orthodontic laboratory, and the second type of expander is designed on a computer and printed using 3D printers. Both expanders are already used in the MUSC Orthodontics Clinic. The purpose of this study is to see if the 3D printed expander is as effective as the traditional expander made by hand in the laboratory, with more comfort to the patient. Patients participating in the study will be randomly assigned to one of two groups: group A will be treated with a laboratory-made maxillary expander, and group B with a 3D-Printed maxillary expander. Information will be collected on the participants' standard clinical follow-up visits including photos, x-rays, and dental photo scans over the course of 6 months to see how the expander is working. In addition, as part of the research study, the participant will be asked to complete online questionnaires with assistance from parents or guardians about his/her quality of life and perception of possible pain and discomfort at different time points. The potential benefits of this study include the use of 3D technology to improve the quality of the orthodontic treatment, with more comfort to the patient.

Вмешательства

  • Устройство 3D-Printed Hyrax Expander
    This is a type of maxillary expander that is designed on a computer and printed in metal using 3D printers and is used to expand the upper jaw.
  • Устройство Conventional Laboratory Fabricated Hyrax Expander
    This is a type of maxillary expander that is made by hand in an orthodontic laboratory and is used to expand the upper jaw.

Первичные конечные точки

  • Dimension of the Anterior Midpalatal Suture Opening [Срок оценки: 2 weeks]
Вторичные конечные точки (6)
  • Change in Interincisal Diastema Width [Срок оценки: 2 weeks]
  • Change in Maxillary Molar Inclination [Срок оценки: 2 weeks]
  • Change in Maxillary Arch Widths [Срок оценки: 2 weeks]
  • Pain Perception assessed by Visual Analog Scale [Срок оценки: 2 weeks]
  • Pain Perception assessed by Wong-Baker FACES Scale [Срок оценки: 2 weeks]
  • Oral Health Related Quality of Life (functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicap) assessed by OHIP-14 [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

  • Maxillary anterior and/or posterior transverse deficiency with or without crossbite
  • Age of 8-13 years
  • Children whose parents/guardians are willing to consent to the child participating in the study
  • Children ages 12-13 who are willing to assent to participating in the study
  • Children who are orthodontic patients at the Medical University of South Carolina Department of Orthodontics or University of Pittsburgh School of Dental Medicine
  • Subjects and parents/guardians who have access to an electronic device with internet connection

Критерии исключения

  • Patients with previous or ongoing orthodontic treatment
  • Patients whose parents have a strong preference as to which expander is used
  • Patients with a history of temporomandibular disorders
  • Presence of congenitally missing teeth
  • Traumatic loss of maxillary incisors
  • Patients with craniofacial syndromes, or cleft lip and/or palate

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • University of Pittsburgh - School of Dental Medicine — Pittsburgh
  • Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT05743127 · STUDY24070148

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗