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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Orthodontic Appliance Complication BAME Bone Anchored Rapid Maxillary Expansion Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Dental Malocclusion Jaw Abnormalities Jaw Diseases Malocclusion Mandibular Diseases Maxillary Hypoplasia Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Retrognathia Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Diseases

Age range

19 year–31 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Odontológica de la Universidad de Salamanca, Salamanca, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid maxillary expansion

Procedure

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

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

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Apr 26, 2023
Registry last updated: Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed