Clinical trial NCT07009535: Associations Apnoea Hypopnoea Index (AHI) and Malocclusions in Growing Patients With Maxillary Constriction
Official title: Associations Apnoea Hypopnoea Index (AHI) and Malocclusions in Growing Patients With Maxillary Constriction: a Prospective Clinical Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Apnea, Obstructive Sleep
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

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

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
Secondary outcomes:
measure: SNA Angle
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: SNB Angle
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: ANB Angle
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: Cranio-mandibular Angle (SN^GoGn)
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: Intermaxillary Angle (ANS-PNS^GoGn)
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: Ad1-SNP
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: Ad2-SNP
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: MPP-SPAS
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: U1-U2
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: T1-T2
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: Thickness (MPP-MPA)
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: Length (U-SNP)
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: MPH
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: Molar Class
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: Overjet
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: Overbite
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
measure: Oxygen Saturation (Nadir SpO2)
timeFrame: Baseline (T0) and after 1 year of treatment with RPE (T1)
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: Associate Professor
name: Andrea Scribante, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: