Upper Airways Cephalometric Measures Compared to Skeletal Class and Divergence
NCT ID: NCT05725980
Last Updated: 2023-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
120 participants
OBSERVATIONAL
2023-02-12
2023-03-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Skeletal Class I patients
Patients from this group present 0° \< ANB \< 4° on the cephalometric tracing.
Cephalometric analysis
Cephalometric analysis will be performed evaluating upper airways landmarks.
Skeletal Class II patients
Patients from this group present ANB \> 4° on the cephalometric tracing.
Cephalometric analysis
Cephalometric analysis will be performed evaluating upper airways landmarks.
Skeletal Class III patients
Patients from this group present ANB \< 0° on the cephalometric tracing.
Cephalometric analysis
Cephalometric analysis will be performed evaluating upper airways landmarks.
Interventions
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Cephalometric analysis
Cephalometric analysis will be performed evaluating upper airways landmarks.
Eligibility Criteria
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Inclusion Criteria
* 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
* nasopharyngeal pathologies
* craniofacial dysmorphisms
* orthognatic surgery
* radiographs not performed in Natural Head Position
* unsuitable radiographs
18 Years
50 Years
ALL
Yes
Sponsors
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Andrea Scribante
OTHER
Responsible Party
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Andrea Scribante
Associate Professor, Principal Investigator
Principal Investigators
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Andrea Scribante, DDS, PhD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Pavia
Locations
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Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, Italy
Countries
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Other Identifiers
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2023-AIRWAYSCLASS
Identifier Type: -
Identifier Source: org_study_id
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