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

Not Applicable

• Conditions: Apertognathia
• Interventions: Procedure: Conventional model surgery; Procedure: Computer guided surgery; Device: 3D computerized tomography; Device: 2D cephalometric radiograph

• Registration Number: NCT03277443
• Lead Sponsor: Ammar Ribhi Abu shama

Brief Summary

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

Detailed Description

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)

Study Timeline

• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-11
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-14
• Study Start: 2018-02-20
• Primary Completion: 2018-12-30
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Computer guided surgery	3D computerized tomography	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.
Conventional Model Surgery	2D cephalometric radiograph	Lateral Cephalogram with analysis and tracing of facial profile. Modified model surgical tecnique: 1. Obtain wax bite registration. 2. Record face-bow transfer. 3. Duplication of articulating model for surgical simulation. 4. Measure all casts and bases in standard model surgery fashion. 5. Fabricate intermediate splint \& Final splint. 6. Condylar repositional splint.
Conventional Model Surgery	Conventional model surgery	Lateral Cephalogram with analysis and tracing of facial profile. Modified model surgical tecnique: 1. Obtain wax bite registration. 2. Record face-bow transfer. 3. Duplication of articulating model for surgical simulation. 4. Measure all casts and bases in standard model surgery fashion. 5. Fabricate intermediate splint \& Final splint. 6. Condylar repositional splint.
Computer guided surgery	Computer guided surgery	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of movement of surgical segments in millimeter	up to 4 months	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).

Secondary Outcome Measures

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