Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05725980
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2023-02-02
Brief Title:
Upper Airways Cephalometric Measures Compared to Skeletal Class and Divergence
Sponsor:
Andrea Scribante
Organization:
University of Pavia
Study Overview
Official Title:
A Retrospective Cephalometric Study on Upper Airways Changes Compared to Skeletal Angle Class and Divergence a Retrospective Observational Study
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 221 Outside Format Spino dAdda Italy Riedels ANB angle Riedel 1952 has been adopted to determine patients skeletal class Steiners SNGoGn 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 005 and power 95 an expected mean value of 3105 with a standard deviation of 416 was hypothesized with an expected mean difference of 334 Sprenger et al 2017 therefore 40 patients per group were required
Statistical analysis will be conducted with R software version 313 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 SNGoGn ANSPNSGoGn PT PL sex and age
For each lateral cephalometric radiograph a cephalometric tracing will be performed with DeltaDent software version 221 Outside Format Spino dAdda Italy Riedels ANB angle Riedel 1952 has been adopted to determine patients skeletal class Steiners SNGoGn 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 005 and power 95 an expected mean value of 3105 with a standard deviation of 416 was hypothesized with an expected mean difference of 334 Sprenger et al 2017 therefore 40 patients per group were required
Statistical analysis will be conducted with R software version 313 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 SNGoGn ANSPNSGoGn PT PL sex and age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None