Clinical trial NCT06197880: Airway Morphology After En-masse Retraction in Bimaxillary Protrusion Patients
Official title: Three-dimensional Evaluation of the Airway Morphology After En-masse Retraction in Bimaxillary Protrusion Patients by Using Cone Beam Computed Tomography
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Airway
Keywords: en-masse retraction airway morphology CBCT
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm clinical trial
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: assess the changes in the airway morphology
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Faculty of Dentistry Beni Suef University
Study officials:
affiliation: Faculty of Dentistry Beni Suef University
name: Rehab Khalil
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.