Clinical Trials Directory

Trials / Completed

CompletedNCT05831722

Changes in the Upper Airway Volume After Rapid Maxillary Expansion in Adults Using Pure Skeletal Anchorage

Status
Completed
Phase
Study type
Observational
Enrollment
18 (actual)
Sponsor
University of Salamanca · Academic / Other
Sex
All
Age
19 Years – 31 Years
Healthy volunteers
Accepted

Summary

The objective of this study is to evaluate the effect of bone-anchored rapid maxillary expansion (RME) in the volume of the right maxillary sinus, left maxillary sinus and nasal and maxillary sinus airway complex, through bone anchored maxillary expansion devices (BAME); in addition, the influence of gender and age in the volume changes will be also analyzed. Material and method: 18 patients between undergone RME treatment with a jackscrew based on 4 miniscrews which will be placed in the palate on both sides of the midpalatal suture. Cone-beam computed tomography (CBCT) scans will be taken before and after suture palatine expansion and datasets will be uploaded into therapeutic digital planning software to measure the volume (mm3) of the right maxillary sinus, left maxillary sinus (mm3) and nasal and maxillary sinus airway complex (mm3). The airway volumes will be isolated after selecting the anatomical area in the axial, coronal and sagittal space plane and ensuring the air density measurement by reference points placement inside the selected area. Statistical analysis between preoperative and postoperative measurements will be performed using the statistical analysis of the t-test.

Conditions

Interventions

TypeNameDescription
PROCEDURERapid Maxillary ExpansionRapid Maxillary Expansion consists in the mid palatal suture opening through temporary anchorage mini implants placed in the palatal area.

Timeline

Start date
2021-11-01
Primary completion
2022-12-30
Completion
2023-02-28
First posted
2023-04-26
Last updated
2023-04-26

Locations

3 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT05831722. Inclusion in this directory is not an endorsement.