Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite

Study Overview
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Brief Summary
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In patient with skeletal open bite, Dose computer-aided surgery enhances the clinical outcomes and accuracy versus conventional model surgery

Detailed Description
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P Adult Patients with skeletal open bite. I Computer guided surgery. C Conventional articulating model surgery O Outcome measure: Outcome Name Measuring Device Measuring Unit (mm) O1 Accuracy Computer guided: Super-imposition of virtual surgery over the post- operative CT Scan composite models ( millimeter mm) Conventional : Super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion ( millimeter mm) O2 Anterior open Bite Closure Standardized Multi Scan CT (millimeter mm)

Official Title
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Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite: A Randomized Clinical Trial

Conditions
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Apertognathia

Intervention / Treatment
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* Procedure: Computer guided surgery
* Procedure: Conventional model surgery
* Device: 2D cephalometric radiograph
* Device: 3D computerized tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from skeletal open bite caused by vertical posterior maxillary excess and/or short mandible ramus. Patients should be free from any systemic disease that may affect normal healing, and predictable outcome. Required two jaws orthographic surgery Exclusion Criteria: Patients with any systemic disease that may affect normal healing Intra-bony lesions or infections that may retard the osteotomy healing. Patient with bad oral hygiene. Uncontrolled Diabetes mellitus.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: SM and VSM
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Model Surgery<br>Lateral Cephalogram with analysis and tracing of facial profile. Modified model surgical tecnique: Obtain wax bite registration. Record face-bow transfer. Duplication of articulating model for surgical simulation. Measure all casts and bases in standard model surgery fashion. Fabricate intermediate splint & Final splint. Condylar repositional splint. | Procedure: Conventional model surgery<br>* preparation for orthognathic surgery which involves diagnosis with 2D cephalometric radiograph, face-bow transfer and model surgery on plaster dental cast, and fabrication of intermediate and final occlusal splint.<br>Device: 2D cephalometric radiograph<br>* 2D cephalometric radiograph<br>|
| Experimental: Computer guided surgery<br>Preoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan. Computer-aided planning for study group: All planning will be done using specialized software (Anatomage Invivo 5.3) for preoperative surgical simulation and immediate postoperative evaluation. Pre-operative Fabrication of computer aided surgical splint: In the study group a stereo splint will be fabricated using rapid prototyping (RP) technique to guide the osteotomy and another one will be fabricated after virtual osteotomy to guide the surgical cuts. And stent for guided holes. So that the osteotomy will be accomplished by the aid of computer guided templates that simulates the proper bite achieved preoperatively during surgical simulation and Planning. | Procedure: Computer guided surgery<br>* Preoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan.Craniofacial images from 3D computerized tomography (3D-CT scan) can be used to create a 3D model, which can in turn be used for 3D Cephalometry measurements and surgical simulation.The process of 3D-model contains mounting of 3D virtual models in a 3D virtual articulator; and repositioning of 3D virtual models according to the STO then Fabrication of a 3D virtual intermediate surgical wafer; and materialization of the surgical wafer using a stereolithographic technique. The 3D model can produce actual movement of surgical cuts and movement of segments accordingly<br>Device: 3D computerized tomography<br>* 3D computerized tomography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of movement of surgical segments in millimeter | Computer guided Super-imposition of virtual surgery over the post- operative CT Scan composite models (millimeter mm). Conventional Super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion- accuracy would be compared by difference between Intervention and control in (millimeter mm). | up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior open Bite Closure (positive overbite in millimeter) | Standardized pre-surgery movement in amount of anterior open bite closure (mm) will be determined clinically and by radiograph. | up to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skeletal open bite