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CompletedNCT04629859Updated Aug 7, 2023

Orthognathic Surgeries and Pharyngeal Airway Space

An interventional study of mandibular setback and maxillary advancement and mandibular setback in Mandibular Prognathism, sponsored by Fayoum University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-07.

Sponsored by Fayoum University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2020, registered Nov 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Mandibular Prognathism

Keywords

  • Orthognathic surgery
  • Pharyngeal airway space
  • skeletal class III patients.
03

In context

Malocclusion, Angle Class III

57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.

This study's enrollment of 24 is below the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.

Browse Malocclusion, Angle Class III studies →

Lead sponsor

Fayoum University is the lead sponsor of 148 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with craniofacial syndromes.
  • Medically compromised patients and patients with bone anomalies
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    study arm

    dento skeletal class III patients will undergo a mandibular setback surgery and maxillary advancement

    Procedure: mandibular setback and maxillary advancement

  • Experimental
    controlled arm

    dento skeletal class III patients will undergo a mandibular setback surgery

    Procedure: mandibular setback

Interventions

  • Proceduremandibular setback and maxillary advancement

    12 patients will undergo mandibular setback and maxillary advancement

  • Proceduremandibular setback

    12 patients will undergo mandibular setback

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. Epworth sleepiness scale

    (0-24) score to assess sleep apnea indirect

    Time frame: 6 months

07

Study locations

1 site
  • Fayoum University
    Fayoum, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04629859
Lead sponsor
Fayoum University
Responsible party
Shaimaa Mohsen (principal investigator, Fayoum University) — Principal investigator
First posted
Nov 16, 2020
Start date
Jan 1, 2020
Primary completion
Nov 30, 2020
Completion
Dec 1, 2020
Last update
Aug 7, 2023

Study contacts

hussien hatem, phd
study director · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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