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

NCT ID: NCT05831722

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-02-28

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Rapid Maxillary Expansion

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

31 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

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JAVIER MONTERO

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinica Odontológica de la Universidad de Salamanca

Salamanca, , Spain

Site Status

Javier Montero

Salamanca, , Spain

Site Status

University of Salamanca

Salamanca, , Spain

Site Status

Countries

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Spain

Other Identifiers

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USAL 2023-AZM

Identifier Type: -

Identifier Source: org_study_id

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