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临床试验/NCT07009535
NCT07009535Enrolling By Invitation不适用

Associations Apnoea Hypopnoea Index (AHI) and Malocclusions in Growing Patients With Maxillary Constriction: a Prospective Clinical Study.

University of Pavia2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
20
试验地点
2
主要终点
Apnea-Hypopnea Index (AHI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • mixed dentition
  • transversal skeletal constriction of the upper jaw, with or without cross-bite
  • Tonsillar grade I-III according to Mallampati classification

排除标准

  • 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

结局指标

主要结局

Apnea-Hypopnea Index (AHI)

时间窗: Baseline (T0) and after 1 year of treatment with RPE (T1)

The number of apneas and/or hypopneas per hour of recording. It is considered mild OSAS if AHI is between 1 and 5; moderate OSAS if AHI is between 5 and 10; severe OSAS if AHI is greater than 10.

次要结局

  • SNA Angle(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • SNB Angle(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • ANB Angle(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • Cranio-mandibular Angle (SN^GoGn)(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • Intermaxillary Angle (ANS-PNS^GoGn)(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • Ad1-SNP(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • MPP-SPAS(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • U1-U2(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • Ad2-SNP(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • T1-T2(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • Oxygen Saturation (Nadir SpO2)(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • Thickness (MPP-MPA)(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • Length (U-SNP)(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • MPH(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • Molar Class(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • Overjet(Baseline (T0) and after 1 year of treatment with RPE (T1))
  • Overbite(Baseline (T0) and after 1 year of treatment with RPE (T1))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Scribante

Associate Professor, Principal Investigator

University of Pavia

研究点 (2)

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