Airway Morphology After En-masse Retraction in Bimaxillary Protrusion Patients

Airway Clinical Trial

Official title:

Three-dimensional Evaluation of the Airway Morphology After En-masse Retraction in Bimaxillary Protrusion Patients by Using Cone Beam Computed Tomography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06197880
• Other study ID #: # REC-FDBSU/07072022-01/AR
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 20, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: December 2023
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to three-dimensionally assess the changes in the airway morphology after anterior segment retraction using maximum anchorage.

Description:

Participants were recruited from the Faculty of Dentistry, Beni-Suef University. All subjects were informed of the treatment procedures and signed a consent form.

Methodology:

The patients were treated by using fixed appliance and extraction of four first premolars. Maximum anchorage was obtained by using miniscrews that were inserted between the maxillary first molars and second premolars. En masse retraction of the upper and lower anterior segments was carried out by using NiTi closed coil springs.

Cone beam computed tomography (CBCT) will be obtained before (T0) and after en masse retraction (T1). CBCT will be used for three-dimensional evaluation of the changes of the airway morphology after en masse retraction of the upper and lower anterior segments with maximum anchorage.

The results will be obtained and statistically evaluated.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 1, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Class I bimaxillary protrusion requiring extraction of four first premolars and en masse retraction of the anterior segments.

2. Age: 18 - 35 years old.

3. Fair oral hygiene.

Exclusion Criteria:

1. Active periodontal disease.

2. Systemic diseases or medications that alter bone metabolism.

Related Conditions & MeSH terms

• Airway

Intervention

Other:
• Anterior teeth retraction
En masse retraction of the upper and lower anterior segments using maximum anchorage

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Beni Suef University	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Chen Y, Hong L, Wang CL, Zhang SJ, Cao C, Wei F, Lv T, Zhang F, Liu DX. Effect of large incisor retraction on upper airway morphology in adult bimaxillary protrusion patients. Angle Orthod. 2012 Nov;82(6):964-70. doi: 10.2319/110211-675.1. Epub 2012 Mar 30. — View Citation

Valiathan M, El H, Hans MG, Palomo MJ. Effects of extraction versus non-extraction treatment on oropharyngeal airway volume. Angle Orthod. 2010 Nov;80(6):1068-74. doi: 10.2319/010810-19.1. — View Citation

Wang Q, Jia P, Anderson NK, Wang L, Lin J. Changes of pharyngeal airway size and hyoid bone position following orthodontic treatment of Class I bimaxillary protrusion. Angle Orthod. 2012 Jan;82(1):115-21. doi: 10.2319/011011-13.1. Epub 2011 Jul 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the changes in the airway morphology	measure the airway volume before and after treatment	6 months