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

Completed

• Conditions: Orthodontic Appliance Complication; Dental Malocclusion; Bone Anchored Rapid Maxillary Expansion; Maxillary Hypoplasia; BAME

• Registration Number: NCT05831722
• Lead Sponsor: University of Salamanca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2022-12-30
• Study Completion: 2023-02-28
• Status Verified: 2023-04
• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-25
• Last Update Submitted: 2023-04-25
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	2 months after bone anchored maxillary expansion is completed

Trial Locations

Locations (3)

Javier Montero; 🇪🇸 Salamanca, Spain

University of Salamanca; 🇪🇸 Salamanca, Spain

Clinica Odontológica de la Universidad de Salamanca; 🇪🇸 Salamanca, Spain