Orthognathic Surgeries and Pharyngeal Airway Space

Mandibular Prognathism Clinical Trial

Official title:

Malocclusion Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04629859
• Other study ID #: 12/10/19
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: August 2023
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

twenty-four patients with dentoskeletal deformity of class III will be divided equally into two groups and will be subjected to orthognathic surgeries group A; will be treated by mandibular setback surgery while group B will be treated with bimaxillary orthognathic surgery in the form of mandibular setback and maxillary advancement surgeries. the total pharyngeal airway will be measured on lateral cephalometric radiographs, integrating retro-palatal and retro-glossal area, and statistically will be compared preoperative, immediate postoperative, and at 6 months post-surgically

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 1, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• dento-skeletal class III malocclusion which needed a surgical intervention with maxillary advancement surgery and/or mandibular set-back orthognathic surgery in the form of bilateral sagittal split osteotomy

• no previous orthognathic surgery

Exclusion Criteria:

• Patients with craniofacial syndromes.

• Medically compromised patients and patients with bone anomalies

Related Conditions & MeSH terms

• Malocclusion, Angle Class III
• Mandibular Prognathism
• Prognathism

Intervention

Procedure:
• mandibular setback and maxillary advancement
12 patients will undergo mandibular setback and maxillary advancement
• mandibular setback
12 patients will undergo mandibular setback

Locations

Country	Name	City	State
Egypt	Fayoum University	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total pharyngeal airway space surface area	Cephalometric analyses will be performed, the pharyngeal airway is demarcated inferiorly by a line passing through the tip of epiglottis and the superior tip of the hyoid bone, namely Line A, while the retro-glossal and the retro-palatal airway is separated by a line extending from the basion parallel to line A.; All the reference points and lines were conveyed to the images . The Pharyngeal airway space was measured and compared.	6 months
Secondary	Epworth sleepiness scale	(0-24) score to assess sleep apnea indirect	6 months