Associations Apnoea Hypopnoea Index (AHI) and Malocclusions in Growing Patients With Maxillary Constriction
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: Polysomnography.
- Кому может быть актуально
- Состояния в реестре: Apnea, Obstructive Sleep. 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
- 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
Associations Apnoea Hypopnoea Index (AHI) and Malocclusions in Growing Patients With Maxillary Constriction: a Prospective Clinical Study.
Обзор
The aim of this prospective clinical study is to evaluate the association between the Apnoea Hypopnoea Index (AHI) and the type of malocclusion in pediatric patients with maxillary constriction. Malocclusion will be assessed through clinical examination and cephalometric analysis, which will also include an evaluation of the airway. Additionally, the study aims to assess potential changes in OSAS symptoms in patients undergoing orthopedic-orthodontic treatment with maxillary expansion. The AHI assessment will be conducted using nocturnal cardiorespiratory monitoring.
Подробное описание
This observational study aims to evaluate possible associations between data obtained from cardiorespiratory monitoring, clinical examination, and cephalometric analysis in patients with maxillary constriction. First, patients aged 6 to 12 years who present to the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic, and Pediatric Sciences of the University of Pavia will undergo a clinical examination to assess the presence of malocclusions. If malocclusions are identified, the necessary records for the patient's diagnostic-therapeutic assessment will be collected. During the initial visit, parents will also be asked to complete the PSQ-SRBD questionnaire (1) (Appendix A), which serves as a screening test for OSAS. Subsequently, the transpalatal width will be measured on plaster or digital models by evaluating the intermolar distance. According to McNamara, this value in mixed dentition without crowding or spacing ranges between 34 and 36 mm (2), while it is less than 31 mm in cases of crowding, indicating the need for orthopedic or surgical expansion (3). In this study, a cut-off value of 31 mm was used to select the sample with maxillary constriction. If such a malocclusion is present, the operators will verify whether the patient meets the study's inclusion criteria. Cephalometric analysis will be performed on lateral cranial radiographs, focusing on craniofacial characteristics and upper airway measurements, as detailed later in the protocol. The selected children will then be referred to the Sleep Medicine Center at the Mondino Foundation for cardiorespiratory monitoring (AHI). Data from the polygraphic examination, cephalometric analysis, and clinical evaluation will be compared using statistical analysis. If the patient is diagnosed with OSAS (AHI \>1) and requires palatal expansion, cardiorespiratory monitoring, clinical evaluation, and cephalometric analysis will be repeated after treatment with an expander and compared with the initial data.
Вмешательства
- Диагностический тест Polysomnography
Assessment of AHI index and pO2 in pediatric patients
Первичные конечные точки
- Apnea-Hypopnea Index (AHI) [Срок оценки: Baseline (T0) and after 1 year of treatment with RPE (T1)]
Вторичные конечные точки (12)
- SNA Angle [Срок оценки: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- SNB Angle [Срок оценки: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- ANB Angle [Срок оценки: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- Cranio-mandibular Angle (SN^GoGn) [Срок оценки: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- Intermaxillary Angle (ANS-PNS^GoGn) [Срок оценки: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- Ad1-SNP [Срок оценки: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- Ad2-SNP [Срок оценки: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- MPP-SPAS [Срок оценки: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- U1-U2 [Срок оценки: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- T1-T2 [Срок оценки: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- Thickness (MPP-MPA) [Срок оценки: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- Length (U-SNP) [Срок оценки: Baseline (T0) and after 1 year of treatment with RPE (T1)]
Критерии участия
Критерии включения
- mixed dentition
- transversal skeletal constriction of the upper jaw, with or without cross-bite
- Tonsillar grade I-III according to Mallampati classification
Критерии исключения
- Previous orthodontic treatment
- Previous adenoidectomy, tonsillectomy, or any surgical interventions of the upper airways;
- Tonsillar grade IV
- Presence of remote or familial pathologies;
- Presence of syndromes or forms of disability
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
- Диагностика
Центры проведения
Италия · 1 центр
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia
Идентификаторы
NCT: NCT07009535 · 2025-AHIO2AIRWAYS