TrialReader


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

NCT05831722 — Completed, 18 participants, University of Salamanca

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT05831722
StatusCompleted
Study typeObservational
Enrollment18 (Actual)
SponsorUniversity of Salamanca (Other)
ConditionsOrthodontic Appliance Complication, Dental Malocclusion, Bone Anchored Rapid Maxillary Expansion, Maxillary Hypoplasia, BAME
InterventionsRapid Maxillary Expansion (Procedure)
Datesstart 2021-11-01, primary completion 2022-12-30, completion 2023-02-28, first posted 2023-04-26, last updated 2023-04-26
Locations3 sites in Spain

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Orthodontic Appliance Complication All trials for Dental Malocclusion All trials of Rapid Maxillary Expansion

-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.

Expand all sections  ·  Collapse all

+Arms and 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.

+Outcome measures

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 [2 months after bone anchored maxillary expansion is completed]

+Eligibility

Sex: All, ages: 19 Years to 31 Years, accepts healthy volunteers

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

+Locations (3)

FacilityCityCountryStatus
Clinica Odontológica de la Universidad de SalamancaSalamancaSpain
Javier MonteroSalamancaSpain
University of SalamancaSalamancaSpain

My Notes