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Clinical Trials/NCT05831722
NCT05831722
Completed
Not Applicable

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

University of Salamanca3 sites in 1 country18 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Orthodontic Appliance Complication
Sponsor
University of Salamanca
Enrollment
18
Locations
3
Primary Endpoint
The paired t-test analysis will show any statistically significant differences between the preoperative and postoperative volumes of the nasal and maxillary sinus airway complex
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
February 28, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

JAVIER MONTERO

Director

University of Salamanca

Eligibility Criteria

Inclusion Criteria

  • adult patients
  • no history of systemic conditions that could interfere in bone metabolism and in the surgical process of orthodontic mini-implant placement
  • radiographic imaging (CBCT KAVO OP3D Pro FOV 13X15cm) of maxillary discrepancy of more than 3mm compared with the ideal dimensions according to their mandible

Exclusion Criteria

  • Age more than 31 years old
  • Systematic conditions that interfere in bone metabolism

Outcomes

Primary Outcomes

The paired t-test analysis will show any statistically significant differences between the preoperative and postoperative volumes of the nasal and maxillary sinus airway complex

Time Frame: 2 months after bone anchored maxillary expansion is completed

Study Sites (3)

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