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Completed

NCT Number: NCT05725980

Upper Airways Cephalometric Measures Compared to Skeletal Class and Divergence

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

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Key information

Conditions

Skeletal Malocclusion

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cephalometric Analysis

Diagnostic Test

Cephalometric analysis will be performed evaluating upper airways landmarks.

Primary outcomes

  1. NL (nasopharynx length)

    Time frame: Baseline

    Distance between Ad1 and PNS

  2. PD (nasopharynx depth)

    Time frame: Baseline

    Line parallel to bispinal plane and connecting PNS and the posterior margin of pharynx

  3. SPAS (Superior Pharyngeal Airway Space)

    Time frame: 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

  4. MAS (Mean Airway Space)

    Time frame: Baseline

    U1-U2 distance

  5. PAS min (Pharyngeal Airway Space minimum)

    Time frame: Baseline

    T1-T2 distance along Go-B parallel line

  6. IAS (Inferior Airway Space)

    Time frame: Baseline

    From the superior margin of the epiglottis (Ph1) to the closest perpendicular point on the posterior wall of the pharynx

  7. LPW (Lateral Pharyngeal Wall)

    Time frame: Baseline

    Distance between epiglottic vallecula (Va1) and the posterior wall of pharynx perpendicular to Va1

  8. PT

    Time frame: Baseline

    Soft palate thickness

  9. PL

    Time frame: Baseline

    Soft palate length

  10. MPH (Mandibular Plane - Hyoid bone)

    Time frame: Baseline

    Distance from the most anterior and superior point of the hyoid bone (H1) perpendicular to mandibular plane

Sponsors and collaborators

Lead sponsor

Andrea Scribante

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2023
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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