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

Primary Purpose

Class III Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
the mandible first
the maxilla first
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class III Malocclusion

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

maxilla first group

mandible first group

Arm Description

the maxillary osteotomy is going to be done and fixed first

the mandibular osteotomy is going to be done and fixed first

Outcomes

Primary Outcome Measures

the change in maxilla stability
to assess the change in maxillary stability on cone beam CT obtained immediately and 6 month postoperative. the measuring unit is millimeter

Secondary Outcome Measures

Patient satisfaction
"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

Full Information

First Posted
November 9, 2017
Last Updated
October 18, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03353116
Brief Title
Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Using the Inverted Sequence Approach
Official Title
The Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Treated by Mandible-first Approach Versus Maxilla-first Approach; Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
The investigator will assess the inverted sequence approach in the treatment of class III patient undergoing bimaxillary orthognathic surgery
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class III Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
maxilla first group
Arm Type
Active Comparator
Arm Description
the maxillary osteotomy is going to be done and fixed first
Arm Title
mandible first group
Arm Type
Experimental
Arm Description
the mandibular osteotomy is going to be done and fixed first
Intervention Type
Procedure
Intervention Name(s)
the mandible first
Other Intervention Name(s)
the inverted sequence
Intervention Description
the mandible osteotomy is going to be done and fixed first
Intervention Type
Procedure
Intervention Name(s)
the maxilla first
Other Intervention Name(s)
the regular sequence
Intervention Description
the maxilla osteotomy is going to be done and fixed first
Primary Outcome Measure Information:
Title
the change in maxilla stability
Description
to assess the change in maxillary stability on cone beam CT obtained immediately and 6 month postoperative. the measuring unit is millimeter
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
"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
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with skeletal class III malocclusion requiring bimaxillary orthognathic surgery Patients free from any systemic disease Patients who approved to be included in the trial and signed the informed consent Patients with no signs or symptoms of temporomandibular disorders. Exclusion Criteria: Patients with cleft lip and palate "can have an unfavorable effect on facial growth (LARRY M. WOLFORD, 2002)" Patients receiving chemotherapy or radiotherapy "due to the risk of low bone quality and healing (JW, 2003) " Patients who refused to be included in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed mh hamdy, master
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Middle East
ZIP/Postal Code
11865
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
after the completion of my research i will publish the data in an international journal
Citations:
PubMed Identifier
24531245
Citation
Esteves LS, Castro V, Prado R, de Moraes e Silva CA, do Prado CJ, Trindade Neto AI. Assessment of skeletal stability after counterclockwise rotation of the maxillomandibular complex in patients with long-face pattern subjected to orthognathic surgery. J Craniofac Surg. 2014 Mar;25(2):432-6. doi: 10.1097/SCS.0000000000000395.
Results Reference
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PubMed Identifier
27668193
Citation
Ann HR, Jung YS, Lee KJ, Baik HS. Evaluation of stability after pre-orthodontic orthognathic surgery using cone-beam computed tomography: A comparison with conventional treatment. Korean J Orthod. 2016 Sep;46(5):301-9. doi: 10.4041/kjod.2016.46.5.301. Epub 2016 Sep 19.
Results Reference
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PubMed Identifier
19939425
Citation
Beziat JL, Babic B, Ferreira S, Gleizal A. [Justification for the mandibular-maxillary order in bimaxillary osteotomy]. Rev Stomatol Chir Maxillofac. 2009 Dec;110(6):323-6. doi: 10.1016/j.stomax.2009.09.009. Epub 2009 Nov 25. French.
Results Reference
background
PubMed Identifier
28839184
Citation
Liebregts J, Baan F, de Koning M, Ongkosuwito E, Berge S, Maal T, Xi T. Achievability of 3D planned bimaxillary osteotomies: maxilla-first versus mandible-first surgery. Sci Rep. 2017 Aug 24;7(1):9314. doi: 10.1038/s41598-017-09488-4.
Results Reference
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Assessment of Maxillary Stability in Bimaxillary Orthognathic Patients Using the Inverted Sequence Approach

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