Orthognathic Surgeries and Pharyngeal Airway Space
Primary Purpose
Mandibular Prognathism
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mandibular setback and maxillary advancement
mandibular setback
Sponsored by
About this trial
This is an interventional treatment trial for Mandibular Prognathism focused on measuring Orthognathic surgery, Pharyngeal airway space, skeletal class III patients.
Eligibility Criteria
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
Sites / Locations
- Fayoum University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
study arm
controlled arm
Arm Description
dento skeletal class III patients will undergo a mandibular setback surgery and maxillary advancement
dento skeletal class III patients will undergo a mandibular setback surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Epworth sleepiness scale
(0-24) score to assess sleep apnea indirect
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04629859
Brief Title
Orthognathic Surgeries and Pharyngeal Airway Space
Official Title
Malocclusion Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Prognathism
Keywords
Orthognathic surgery, Pharyngeal airway space, skeletal class III patients.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study arm
Arm Type
Experimental
Arm Description
dento skeletal class III patients will undergo a mandibular setback surgery and maxillary advancement
Arm Title
controlled arm
Arm Type
Experimental
Arm Description
dento skeletal class III patients will undergo a mandibular setback surgery
Intervention Type
Procedure
Intervention Name(s)
mandibular setback and maxillary advancement
Intervention Description
12 patients will undergo mandibular setback and maxillary advancement
Intervention Type
Procedure
Intervention Name(s)
mandibular setback
Intervention Description
12 patients will undergo mandibular setback
Primary Outcome Measure Information:
Title
total pharyngeal airway space surface area
Description
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 Outcome Measure Information:
Title
Epworth sleepiness scale
Description
(0-24) score to assess sleep apnea indirect
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hussien hatem, phd
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Fayoum University
City
Fayoum
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Orthognathic Surgeries and Pharyngeal Airway Space
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