Clinical trial NCT05725980: Upper Airways Cephalometric Measures Compared to Skeletal Class and Divergence
Official title: A Retrospective Cephalometric Study on Upper Airways Changes Compared to Skeletal Angle Class and Divergence: a Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skeletal Malocclusion
Keywords: Upper airways dimensions
Skeletal Class
Skeletal Divergency
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referring to the Unit of Orthodontics and Pediatric Dentistry for orthodontic consultation.

Brief summary: The aim of the present study is to investigate the baseline upper airways dimensions in adult patients belonging to all skeletal classes

Detailed description: Lateral cephalometric radiographs of adult orthodontic patients referring for orthodontic consultation at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, 27100 Pavia, Italy, will be collected for the study according to the inclusion criteria.

For each lateral cephalometric radiograph, a cephalometric tracing will be performed with DeltaDent software (version 2.2.1, Outside Format, Spino d'Adda, Italy). Riedel's ANB angle \[Riedel 1952\] has been adopted to determine patients' skeletal class. Steiner's SN\^GoGn angle \[Steiner 1953\] will be used to evaluate skeletal divergence. Biprotrusion will be assessed for SNA \> 84° and SNB \> 82°, while biretrusion for SNA \< 80° and SNB \< 78°.

Sample size calculation was performed with "soft palate length" as primary outcome. Considering alpha = 0.05 and power = 95%, an expected mean value of 31.05 with a standard deviation of 4.16 was hypothesized, with an expected mean difference of 3.34 \[Sprenger et al. 2017\], therefore 40 patients per group were required.

Statistical analysis will be conducted with R® software (version 3.1.3 R Development Core Team, R Foundation for Statistical Computing, Wein, Austria). For each cephalometric measure belonging to the three skeletal classes, descriptive statistics (mean and standard deviation) will be calculated. Appropriate statistical tests will be used to assess data normality and multiple comparisons. Linear regressions will be performed between upper airways diameters and SNA, SNB, ANB, SN\^GoGn, ANSPNS\^GoGn, PT, PL, sex and age.

Eligibility criteria: Inclusion Criteria:

* Patients with permanent dentition
* Caucasian patients
* Patients with one lateral cephalometric digital radiograph executed in Natural Head Position (patients were asked to keep the teeth in contact and the lips relaxed).

Exclusion Criteria:

* maxillo-facial traumas
* nasopharyngeal pathologies
* craniofacial dysmorphisms
* orthognatic surgery
* radiographs not performed in Natural Head Position
* unsuitable radiographs

Primary outcomes:
measure: NL (nasopharynx length)
timeFrame: Baseline
measure: PD (nasopharynx depth)
timeFrame: Baseline
measure: SPAS (Superior Pharyngeal Airway Space)
timeFrame: Baseline
measure: MAS (Mean Airway Space)
timeFrame: Baseline
measure: PAS min (Pharyngeal Airway Space minimum)
timeFrame: Baseline
measure: IAS (Inferior Airway Space)
timeFrame: Baseline
measure: LPW (Lateral Pharyngeal Wall)
timeFrame: Baseline
measure: PT
timeFrame: Baseline
measure: PL
timeFrame: Baseline
measure: MPH (Mandibular Plane - Hyoid bone)
timeFrame: Baseline
Secondary outcomes:
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: University of Pavia
name: Andrea Scribante, DDS, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: