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

NCT ID: NCT03277443

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-20
• Study Completion Date: 2019-05-30

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)

Conditions

Apertognathia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Conventional model surgery

Intervention Type: PROCEDURE

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.

2D cephalometric radiograph

Intervention Type: DEVICE

2D cephalometric radiograph

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.

Group Type: EXPERIMENTAL

Computer guided surgery

Intervention Type: PROCEDURE

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

3D computerized tomography

Intervention Type: DEVICE

3D computerized tomography

Interventions

Computer guided surgery

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

Intervention Type: PROCEDURE

Conventional model surgery

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.

Intervention Type: PROCEDURE

2D cephalometric radiograph

2D cephalometric radiograph

Intervention Type: DEVICE

3D computerized tomography

3D computerized tomography

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ammar Ribhi Abu shama

OTHER

Sponsor Role: lead

Responsible Party

Ammar Ribhi Abu shama

PHD Doctor in Oral and Maxillofacial Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Moustafa K Ezz, Professor

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

Ammar R Abu Shama, PHD

Role: CONTACT

Dr.ammar.shama@gmail.com

00201142354052

Mamdouh S Sayed Ahmed, Professor

Role: CONTACT

dr.mamdouhahmed@hotmail.com

00201222173262

Other Identifiers

292017

Identifier Type: -

Identifier Source: org_study_id