NCT04629859

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

November 11, 2020

Last Update Submit

August 3, 2023

Conditions

Mandibular Prognathism

Keywords

Orthognathic surgeryPharyngeal airway spaceskeletal class III patients.

Outcome Measures

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.

    6 months

Secondary Outcomes (1)

  • Epworth sleepiness scale

    6 months

Study Arms (2)

study arm

EXPERIMENTAL

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

Procedure: mandibular setback and maxillary advancement

controlled arm

EXPERIMENTAL

dento skeletal class III patients will undergo a mandibular setback surgery

Procedure: mandibular setback

Interventions

mandibular setback and maxillary advancementPROCEDURE

12 patients will undergo mandibular setback and maxillary advancement

study arm
mandibular setbackPROCEDURE

12 patients will undergo mandibular setback

controlled arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • hussien hatem, phd

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 11, 2020

First Posted

November 16, 2020

Study Start

January 1, 2020

Primary Completion

November 30, 2020

Study Completion

December 1, 2020

Last Updated

August 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)