Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances
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: AMCOP appliance.
- Кому может быть актуально
- Состояния в реестре: Transverse Maxillary Deficiency. Базовые параметры: 7 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
- Италия
- 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
Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances: Prospective Clinical Study
Обзор
The present study aimed to investigate the cross-sectional effect of Class I AMCOP devices in patients of all possible skeletal types from both vertical skeletal pattern (normodivergent, hyperdivergent, hypodivergent) and sagittal skeletal pattern (skeletal Class I, skeletal Class II, skeletal Class III). The criterion for choosing patients was determined by the protocol of using these devices, which is to always perform an AMCOP First Class phase with the aim of improving transverse coordination of the arches, Spee's Curve and Wilson's Curve.
Подробное описание
This prospective clinical study will investigate the cross-sectional effect of Class I AMCOP (Cranium Occluded Postural Multifunctional Harmonizers, Micerium spa) devices in patients of all possible skeletal types from both vertical skeletal pattern (normodivergent, hyperdivergent, hypodivergent) and sagittal skeletal pattern (skeletal Class I, skeletal Class II, skeletal Class III).
Patients willing to start AMCOP therapy and recruited for the study will be asked to sign the informed consent. Parents will sign the consent for underage patients.
We will recruit patients by following specific inclusion and exclusion criteria during an orthodontic examination.
Diagnostic records will be recorded before treatment (T0) and after 10-12 months of treatment (T1) and included:
* Intraoral and extraoral photographs * Impressions of the dental arches with digital scanner * Orthopantomography * Lateral teleradiography
Changes will be evaluated at T0 and T1 as follows:
* cross-sectional effects will be analyzed on digital models of the upper and lower arch, taking the following linear measurements with OrthoCad program:
1. upper and lower intermolar distance (taking as reference the top of the mesiovestibular cusp of the upper first molars) 2. upper and lower intercanine distance (taking as reference the top of the cusp) * skeletal changes in latero-lateral teleradiography will be analyzed by using "Giannì cephalometric analysis" The expected duration of the first phase of therapy is averaged 10-12 months. During this time, every month patients will be visited and the devices will be activated.
Вмешательства
- Устройство AMCOP appliance
The device measure will be determined with OrthoCad program on digital models, taking the distance between the vestibular cusps of the upper first molars, at the level of the most prominent point. AMCOPs are preformed devices and there are five different measures based on transverse diameter: 1 (45mm), 2 (50mm), 3 (55mm), 4 (60mm), 5 (65mm). Requiring expansion, we will choose an higher AMCOP measure than the transverse distance measured on the digital models at T0. The clinical indications fo
Первичные конечные точки
- Change in upper intermolar distance on digital casts [Срок оценки: Before treatment (T0) and after 10-12 months of treatment (T1)]
Вторичные конечные точки (12)
- Change in upper intercanine distance on digital casts [Срок оценки: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in lower intercanine distance on digital casts [Срок оценки: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in ANB angle [Срок оценки: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Wits Index [Срок оценки: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Skeletal Class [Срок оценки: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Cranio-Mandibular Angle [Срок оценки: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Intermaxillary Angle [Срок оценки: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Skeletal Vertical Pattern: [Срок оценки: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Articular Angle [Срок оценки: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Upper and Lower Goniac Angles [Срок оценки: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Mandibular growth pattern [Срок оценки: Before treatment (T0) and after 10-12 months of treatment (T1)]
- Change in Upper incisors Inclination [Срок оценки: Before treatment (T0) and after 10-12 months of treatment (T1)]
Критерии участия
Критерии включения
- patients presenting maxillary transverse deficits (that includes: posterior crossbite monolateral or bilateral; end-to-end occlusal relationships; excessive linguoinclination of lower posterior teeth due to the contraction of maxillary arch; limited permutation space of permanent elements)
- patients with all sagittal and vertical skeletal patterns
Критерии исключения
- syndromic patterns, cleft lip or cleft palate, severe malformations of the maxillae, severe skeletal asymmetry
- physical or psychological limitations
- presence of metallic restorations
- previous orthodontic treatments
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Италия · 1 центр
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia
Идентификаторы
NCT: NCT06864949 · 2025-AMCOP