Skeletal MalocclusionNCT05725980
Upper Airways Cephalometric Measures Compared to Skeletal Class and Divergence
An observational study of Skeletal Malocclusion, run by Andrea Scribante at 1 site in Italy.
Trial summary
The aim of the present study is to investigate the baseline upper airways dimensions in adult patients belonging to all skeletal classes Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Skeletal Malocclusion
- What is being tested?
- Cephalometric analysis
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 12 Feb 2023to 26 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients referring to the Unit of Orthodontics and Pediatric Dentistry for orthodontic consultation.
Who may be able to join
- 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).
Who cannot join
- maxillo-facial traumas
- nasopharyngeal pathologies
- craniofacial dysmorphisms
- orthognatic surgery
- radiographs not performed in Natural Head Position
- unsuitable radiographs
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: A Retrospective Cephalometric Study on Upper Airways Changes Compared to Skeletal Angle Class and Divergence: a Retrospective Observational Study
The aim of the present study is to investigate the baseline upper airways dimensions in adult patients belonging to all skeletal classes
Read the 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.
- Conditions
- Skeletal Malocclusion
- Being tested
- Cephalometric analysis
- Keywords
- Upper airways dimensions, Skeletal Class, Skeletal Divergency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cephalometric analysisDiagnostic test
Cephalometric analysis will be performed evaluating upper airways landmarks.
| Study group | Role | What they receive |
|---|---|---|
| Skeletal Class I patients | Patients from this group present 0° < ANB < 4° on the cephalometric tracing. Receives: Diagnostic Test: Cephalometric analysis | |
| Skeletal Class II patients | Patients from this group present ANB > 4° on the cephalometric tracing. Receives: Diagnostic Test: Cephalometric analysis | |
| Skeletal Class III patients | Patients from this group present ANB < 0° on the cephalometric tracing. Receives: Diagnostic Test: Cephalometric analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
NL (nasopharynx length)
Distance between Ad1 and PNS
Measured: Baseline
PD (nasopharynx depth)
Line parallel to bispinal plane and connecting PNS and the posterior margin of pharynx
Measured: 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
Measured: Baseline
MAS (Mean Airway Space)
U1-U2 distance
Measured: Baseline
PAS min (Pharyngeal Airway Space minimum)
T1-T2 distance along Go-B parallel line
Measured: 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
Measured: Baseline
LPW (Lateral Pharyngeal Wall)
Distance between epiglottic vallecula (Va1) and the posterior wall of pharynx perpendicular to Va1
Measured: Baseline
PT
Soft palate thickness
Measured: Baseline
PL
Soft palate length
Measured: Baseline
MPH (Mandibular Plane - Hyoid bone)
Distance from the most anterior and superior point of the hyoid bone (H1) perpendicular to mandibular plane
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start12 Feb 2023
- Primary completion20 Mar 2023
- Study completion26 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea Scribante
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, MS, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725980
- Sponsor's protocol ID
- 2023-AIRWAYSCLASS
- Status last verified
- Mar 2023
- First submitted
- 2 Feb 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cephalometric Study on Upper Airways Changes Compared to Skeletal Angle Class and Divergence: a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT05725980
- Acronym / sponsor ID
- 2023-AIRWAYSCLASS
- Conditions
- Skeletal Malocclusion
- Keywords
- Upper airways dimensions, Skeletal Class, Skeletal Divergency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Andrea ScribanteUniversity, hospital or other
- Study start
- 12 Feb 2023 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 26 Mar 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Skeletal Class I patients | – | Diagnostic Test: Cephalometric analysisPatients from this group present 0° < ANB < 4° on the cephalometric tracing. |
| Skeletal Class II patients | – | Diagnostic Test: Cephalometric analysisPatients from this group present ANB > 4° on the cephalometric tracing. |
| Skeletal Class III patients | – | Diagnostic Test: Cephalometric analysisPatients from this group present ANB < 0° on the cephalometric tracing. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients referring to the Unit of Orthodontics and Pediatric Dentistry for orthodontic consultation.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- maxillo-facial traumas
- nasopharyngeal pathologies
- craniofacial dysmorphisms
- orthognatic surgery
- radiographs not performed in Natural Head Position
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cephalometric analysisCephalometric analysis will be performed evaluating upper airways landmarks. | Diagnostic test | Skeletal Class I patients, Skeletal Class II patients, Skeletal Class III patients |
Primary outcome
NL (nasopharynx length)
Time frame: Baseline
Distance between Ad1 and PNS
PD (nasopharynx depth)
Time frame: Baseline
Line parallel to bispinal plane and connecting PNS and the posterior margin of pharynx
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
MAS (Mean Airway Space)
Time frame: Baseline
U1-U2 distance
PAS min (Pharyngeal Airway Space minimum)
Time frame: Baseline
T1-T2 distance along Go-B parallel line
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
LPW (Lateral Pharyngeal Wall)
Time frame: Baseline
Distance between epiglottic vallecula (Va1) and the posterior wall of pharynx perpendicular to Va1
PT
Time frame: Baseline
Soft palate thickness
PL
Time frame: Baseline
Soft palate length
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD, MS principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skeletal Malocclusion, run by Andrea Scribante at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NL (nasopharynx length) (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.