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

NCT05831722 | Completed

• 1 other identifier: USAL 2023-AZM
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Rapid Maxillary Expansion PROCEDURE

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

Eligibility Criteria

• Age: 19 Years - 31 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

dental clinic patients

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (3)

Clinica Odontológica de la Universidad de Salamanca

Salamanca, 37007, Spain

Location

Javier Montero

Salamanca, 37007, Spain

Location

University of Salamanca

Salamanca, 37008, Spain

Location

MeSH Terms

Conditions

Malocclusion; Retrognathia

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 26, 2023
• Study Start: November 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: February 28, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

ES (3)