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
About this trial
This is an interventional treatment trial for Class III Malocclusion
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
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
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
background
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
background
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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