Associations Apnoea Hypopnoea Index (AHI) and Malocclusions in Growing Patients With Maxillary Constriction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Polysomnography.
- Who it may be relevant to
- Registry conditions: Apnea, Obstructive Sleep. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Associations Apnoea Hypopnoea Index (AHI) and Malocclusions in Growing Patients With Maxillary Constriction: a Prospective Clinical Study.
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test Polysomnography
Assessment of AHI index and pO2 in pediatric patients
Primary outcome measures
- Apnea-Hypopnea Index (AHI) [Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)]
Secondary outcome measures (12)
- SNA Angle [Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- SNB Angle [Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- ANB Angle [Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- Cranio-mandibular Angle (SN^GoGn) [Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- Intermaxillary Angle (ANS-PNS^GoGn) [Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- Ad1-SNP [Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- Ad2-SNP [Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- MPP-SPAS [Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- U1-U2 [Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- T1-T2 [Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- Thickness (MPP-MPA) [Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)]
- Length (U-SNP) [Time frame: Baseline (T0) and after 1 year of treatment with RPE (T1)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinic — Pavia
Identifiers
NCT: NCT07009535 · 2025-AHIO2AIRWAYS