Orthognathic Surgeries and Pharyngeal Airway Space

NCT ID: NCT04629859

Last Updated: 2023-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-01

Brief Summary

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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

Detailed Description

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Conditions

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Mandibular Prognathism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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study arm

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

Group Type EXPERIMENTAL

mandibular setback and maxillary advancement

Intervention Type PROCEDURE

12 patients will undergo mandibular setback and maxillary advancement

controlled arm

dento skeletal class III patients will undergo a mandibular setback surgery

Group Type EXPERIMENTAL

mandibular setback

Intervention Type PROCEDURE

12 patients will undergo mandibular setback

Interventions

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mandibular setback and maxillary advancement

12 patients will undergo mandibular setback and maxillary advancement

Intervention Type PROCEDURE

mandibular setback

12 patients will undergo mandibular setback

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fayoum University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Mohsen

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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hussien hatem, phd

Role: STUDY_DIRECTOR

Cairo University

Locations

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Fayoum University

Al Fayyum, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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12/10/19

Identifier Type: -

Identifier Source: org_study_id

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