Upper Airways Cephalometric Measures Compared to Skeletal Class and Divergence
- Conditions
- Skeletal Malocclusion
- Interventions
- Diagnostic Test: Cephalometric analysis
- Registration Number
- NCT05725980
- Lead Sponsor
- Andrea Scribante
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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).
- maxillo-facial traumas
- nasopharyngeal pathologies
- craniofacial dysmorphisms
- orthognatic surgery
- radiographs not performed in Natural Head Position
- unsuitable radiographs
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Skeletal Class III patients Cephalometric analysis Patients from this group present ANB \< 0° on the cephalometric tracing. Skeletal Class I patients Cephalometric analysis Patients from this group present 0° \< ANB \< 4° on the cephalometric tracing. Skeletal Class II patients Cephalometric analysis Patients from this group present ANB \> 4° on the cephalometric tracing.
- Primary Outcome Measures
Name Time Method PAS min (Pharyngeal Airway Space minimum) Baseline T1-T2 distance along Go-B parallel line
PL Baseline Soft palate length
MPH (Mandibular Plane - Hyoid bone) Baseline Distance from the most anterior and superior point of the hyoid bone (H1) perpendicular to mandibular plane
NL (nasopharynx length) Baseline Distance between Ad1 and PNS
PD (nasopharynx depth) Baseline Line parallel to bispinal plane and connecting PNS and the posterior margin of pharynx
SPAS (Superior Pharyngeal Airway Space) Baseline From the half of the posterior wall of soft palate (MMP) perpendicularly to the closest point on the posterior of the posterior wall of the pharynx
IAS (Inferior Airway Space) Baseline From the superior margin of the epiglottis (Ph1) to the closest perpendicular point on the posterior wall of the pharynx
MAS (Mean Airway Space) Baseline U1-U2 distance
LPW (Lateral Pharyngeal Wall) Baseline Distance between epiglottic vallecula (Va1) and the posterior wall of pharynx perpendicular to Va1
PT Baseline Soft palate thickness
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
🇮🇹Pavia, Lombardy, Italy