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

NCT07009535 | Enrolling By Invitation

• 1 other identifier: 2025-AHIO2AIRWAYS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Apnea, Obstructive Sleep

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index (AHI)

  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.

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

Secondary Outcomes (17)

• 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)

Study Arms (1)

Study group

EXPERIMENTAL

Patients between 6 and 12 years with maxillary constriction (intermolar distance \< 31 mm) requiring rapid palatal expander therapy and with AHI \> 1

Diagnostic Test: Polysomnography

Interventions

Polysomnography DIAGNOSTIC_TEST

Assessment of AHI index and pO2 in pediatric patients

Study group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Andrea Scribante, DDS, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)