Upper Airways Cephalometric Measures Compared to Skeletal Class and Divergence

Skeletal Malocclusion Clinical Trial

Official title:

A Retrospective Cephalometric Study on Upper Airways Changes Compared to Skeletal Angle Class and Divergence: a Retrospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05725980
• Other study ID #: 2023-AIRWAYSCLASS
• Status: Completed
• Start date: February 12, 2023
• Est. completion date: March 26, 2023

Study information

• Verified date: March 2023
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 26, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Skeletal Malocclusion

Intervention

Diagnostic Test:
• Cephalometric analysis
Cephalometric analysis will be performed evaluating upper airways landmarks.

Locations

Country	Name	City	State
Italy	Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
Andrea Scribante

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NL (nasopharynx length)	Distance between Ad1 and PNS	Baseline
Primary	PD (nasopharynx depth)	Line parallel to bispinal plane and connecting PNS and the posterior margin of pharynx	Baseline
Primary	SPAS (Superior Pharyngeal Airway Space)	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	Baseline
Primary	MAS (Mean Airway Space)	U1-U2 distance	Baseline
Primary	PAS min (Pharyngeal Airway Space minimum)	T1-T2 distance along Go-B parallel line	Baseline
Primary	IAS (Inferior Airway Space)	From the superior margin of the epiglottis (Ph1) to the closest perpendicular point on the posterior wall of the pharynx	Baseline
Primary	LPW (Lateral Pharyngeal Wall)	Distance between epiglottic vallecula (Va1) and the posterior wall of pharynx perpendicular to Va1	Baseline
Primary	PT	Soft palate thickness	Baseline
Primary	PL	Soft palate length	Baseline
Primary	MPH (Mandibular Plane - Hyoid bone)	Distance from the most anterior and superior point of the hyoid bone (H1) perpendicular to mandibular plane	Baseline