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

Orthodontic Appliance Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05831722
• Other study ID #: USAL 2023-AZM
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2023
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 28, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 31 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Malocclusion
• Malocclusion
• Maxillary Hypoplasia
• Orthodontic Appliance Complication

Intervention

Procedure:
• Rapid Maxillary Expansion
Rapid Maxillary Expansion consists in the mid palatal suture opening through temporary anchorage mini implants placed in the palatal area.

Locations

Country	Name	City	State
Spain	Clinica Odontológica de la Universidad de Salamanca	Salamanca
Spain	Javier Montero	Salamanca
Spain	University of Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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