NCT05725980

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

February 12, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

February 2, 2023

Last Update Submit

March 26, 2023

Conditions

Keywords

Upper airways dimensionsSkeletal ClassSkeletal Divergency

Outcome Measures

Primary Outcomes (10)

  • NL (nasopharynx length)

    Distance between Ad1 and PNS

    Baseline

  • PD (nasopharynx depth)

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

    Baseline

  • 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

  • MAS (Mean Airway Space)

    U1-U2 distance

    Baseline

  • PAS min (Pharyngeal Airway Space minimum)

    T1-T2 distance along Go-B parallel line

    Baseline

  • 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

  • LPW (Lateral Pharyngeal Wall)

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

    Baseline

  • PT

    Soft palate thickness

    Baseline

  • PL

    Soft palate length

    Baseline

  • MPH (Mandibular Plane - Hyoid bone)

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

    Baseline

Study Arms (3)

Skeletal Class I patients

Patients from this group present 0° \< ANB \< 4° on the cephalometric tracing.

Diagnostic Test: Cephalometric analysis

Skeletal Class II patients

Patients from this group present ANB \> 4° on the cephalometric tracing.

Diagnostic Test: Cephalometric analysis

Skeletal Class III patients

Patients from this group present ANB \< 0° on the cephalometric tracing.

Diagnostic Test: Cephalometric analysis

Interventions

Cephalometric analysisDIAGNOSTIC_TEST

Cephalometric analysis will be performed evaluating upper airways landmarks.

Skeletal Class I patientsSkeletal Class II patientsSkeletal Class III patients

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients referring to the Unit of Orthodontics and Pediatric Dentistry for orthodontic consultation.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

Study Officials

  • Andrea Scribante, DDS, PhD, MS

    University of Pavia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Principal Investigator

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 13, 2023

Study Start

February 12, 2023

Primary Completion

March 20, 2023

Study Completion

March 26, 2023

Last Updated

March 28, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Data will be available upon motivated request to the Principal Investigator.

Locations