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Clinical Trials in Italy / NCT07009535
Enrolling by invitation Not applicable

Associations Apnoea Hypopnoea Index (AHI) and Malocclusions in Growing Patients With Maxillary Constriction

NCT07009535 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Pavia
Phase
Not applicable
Started
2025-07-01
Last updated
2025-11-18

Condition(s) studied

Apnea, Obstructive Sleep

Investigational drug(s) / intervention(s)

Polysomnography

Polysomnography: Assessment of AHI index and pO2 in pediatric patients

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria: * mixed dentition * transversal skeletal constriction of the upper jaw, with or without cross-bite * Tonsillar grade I-III according to Mallampati classification Exclusion Criteria: * 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

Primary outcome measure(s)

  • Apnea-Hypopnea Index (AHI) — 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.

Trial sites (1)

FacilityCityRegionStatus
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia Pavia Lombardy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07009535 on ClinicalTrials.gov ↗ ← All trials in Italy