Меню
Идёт набор NCT07262892

3D Evaluation of Maxillary Expansion Methods

Без фазы С лечением Maxillary Transverse Deficiency

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: Invisalign Palatal Expander (IPE), Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance.
Кому может быть актуально
Состояния в реестре: Maxillary Transverse Deficiency. Базовые параметры: 6 лет — 12 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Three-Dimensional Evaluation of the Effects of Different Maxillary Expansion Methods

Обзор

This controlled prospective clinical trial aims to evaluate the effectiveness of different maxillary expansion methods in children with maxillary transverse deficiency. A total of 60 participants will be included: 20 patients will receive Invisalign Palatal Expander (IPE), 20 will receive acrylic cap splint Rapid Maxillary Expansion (RME), and 20 will serve as an untreated control group. Three-dimensional (3D) intraoral and extraoral scans will be taken at the end of expansion, at 3 months, and at 6 months. Primary outcomes include maxillary arch width, first molar angulation, palatal surface area, and palatal volume. Secondary outcomes include soft tissue changes in the facial region. This study provides a direct comparison between a traditional and a modern digital expansion method, generating evidence for clinical decision-making in pediatric orthodontics.

Подробное описание

Maxillary transverse deficiency is a common craniofacial problem that often presents with posterior crossbite and dental crowding. Rapid Maxillary Expansion (RME) achieves sutural separation and bone remodeling, typically activated at 0.5 mm per day. Invisalign® Palatal Expander (IPE) is a modern digital system using 3D printing to produce removable nylon expanders adapted to palatal curvature, with 0.25 mm activations, simplifying oral hygiene and eliminating screw activation.

This controlled prospective clinical trial will recruit 60 children with maxillary transverse deficiency. Participants will be assigned to three groups: IPE (n=20), RME (n=20), and untreated control (n=20). Intraoral scans will be obtained at the end of expansion, at 3 months, and at 6 months to create three-dimensional digital models. Maxillary dental arch widths, first molar angulations, palatal surface areas, and volumes will be measured. Extraoral 3D facial scans will evaluate soft tissue changes, including nasal tip, alar width, and interzygomatic distance.

Statistical analyses will be performed using SPSS, applying t-tests for intra- and inter-group comparisons. The study aims to provide comparative data on a traditional (RME) and a contemporary digital (IPE) maxillary expansion method. No prior studies have directly compared these two techniques in children.

Вмешательства

  • Устройство Invisalign Palatal Expander (IPE)
    A removable, nylon palatal expander produced via digital workflow and 3D printing. Activations are planned at 0.25 mm per activation according to manufacturer protocol. Device is fitted to palatal curvature and used until desired expansion achieved, followed by retention.
  • Устройство Acrylic Cap Splint Rapid Maxillary Expansion (RME) Appliance
    Bonded acrylic cap splint RME with a jackscrew activated typically at 0.5 mm per day until expansion goal is reached, followed by retention period. Used in pediatric orthodontic practice.

Первичные конечные точки

  • Change in Maxillary First Molar Tipping [Срок оценки: Baseline (T0), 3 months after expansion (T1), and 6-month retention period (T2)]

Критерии участия

Критерии включения

  • Children aged 6-12 years
  • Good oral hygiene and adequate patient cooperation
  • No previous orthodontic expansion treatment

Критерии исключения

  • Systemic diseases affecting growth, bone metabolism, or craniofacial development
  • Craniofacial syndromes or congenital anomalies
  • Severe behavioral or cooperation problems
  • Previous orthodontic or orthopedic maxillary expansion
  • Patients undergoing medications that affect bone metabolism

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
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Bezmialem Vakif University — Istanbul

Публикации

  • Bruni A, Ferrillo M, Gallo V, Parrini S, Garino F, Castroflorio T, Deregibus A. Efficacy of clear aligners vs rapid palatal expanders on palatal volume and surface area in mixed dentition patients: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2024 Sep;166(3):203-214. doi: 10.1016/j.ajodo.2024.04.006. Epub 2024 Jul 26. PMID 39066746
  • Turker G, Coban G, Bayraktar AU, Kurt G, Kilic E, Alkan A. Three-dimensional palatal morphology and upper arch changes following nonsurgical and surgical maxillary expansion in adults. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 Oct;134(4):425-431. doi: 10.1016/j.oooo.2022.02.013. Epub 2022 Mar 3. PMID 35490136

Идентификаторы

NCT: NCT07262892 · E.181356

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗