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

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

Detailed Description
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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)

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

Conditions
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Class III Malocclusion

Intervention / Treatment
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* Procedure: the mandible first
* Procedure: the maxilla first


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: maxilla first group<br>the maxillary osteotomy is going to be done and fixed first | Procedure: the maxilla first<br>* the maxilla osteotomy is going to be done and fixed first<br>* Other names: the regular sequence;|
| Experimental: mandible first group<br>the mandibular osteotomy is going to be done and fixed first | Procedure: the mandible first<br>* the mandible osteotomy is going to be done and fixed first<br>* Other names: the inverted sequence;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 month |