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OpenTrials
Completed

NCT Number: NCT04629859

Orthognathic Surgeries and Pharyngeal Airway Space

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

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Key information

Conditions

Mandibular Prognathism Malocclusion Malocclusion, Angle Class III Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fayoum University

Al Fayyum, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mandibular setback and maxillary advancement

Procedure

12 patients will undergo mandibular setback and maxillary advancement

mandibular setback

Procedure

12 patients will undergo mandibular setback

Primary outcomes

  1. total pharyngeal airway space surface area

    Time frame: 6 months

    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.

Secondary outcomes

  1. Epworth sleepiness scale

    Time frame: 6 months

    (0-24) score to assess sleep apnea indirect

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

Malocclusion Patients

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 16, 2020
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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