Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Using the Inverted Sequence Approach

October 18, 2022 updated by: Mohamed Hamdy, Cairo University

The Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Treated by Mandible-first Approach Versus Maxilla-first Approach; Randomized Controlled Clinical Trial

The investigator will assess the inverted sequence approach in the treatment of class III patient undergoing bimaxillary orthognathic surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigator will compare the maxillary stability in class III orthognathic patients undergoing bimaxillary surgery by two surgical approaches ; the mandible-first (intervention) and the maxilla-first (control)

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Middle East
      • Cairo, Middle East, Egypt, 11865
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with skeletal class III malocclusion requiring bimaxillary orthognathic surgery
  2. Patients free from any systemic disease
  3. Patients who approved to be included in the trial and signed the informed consent
  4. Patients with no signs or symptoms of temporomandibular disorders.

Exclusion Criteria:

  1. Patients with cleft lip and palate "can have an unfavorable effect on facial growth (LARRY M. WOLFORD, 2002)"
  2. Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing (JW, 2003) "
  3. Patients who refused to be included in the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: maxilla first group
the maxillary osteotomy is going to be done and fixed first
Procedure: the maxilla first
the maxilla osteotomy is going to be done and fixed first
Other Names:
  • the regular sequence
Experimental: mandible first group
the mandibular osteotomy is going to be done and fixed first
Procedure: the mandible first
the mandible osteotomy is going to be done and fixed first
Other Names:
  • the inverted sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in maxilla stability
Time Frame: 6 months

to assess the change in maxillary stability on cone beam CT obtained immediately and 6 month postoperative.

the measuring unit is millimeter
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 6 month
"the quality of life questionnaire" describes the patient's satisfaction during the entire treatment period which is done through a questionnaire answered by the patient through a score between 0-10 the measuring unit is numerical
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: mohamed mh hamdy, master, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

November 9, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2017-11-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

after the completion of my research i will publish the data in an international journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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