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

Ammar Ribhi Abu shama

Status: Unknown

Conditions: Apertognathia

Treatments: Procedure: Conventional model surgery; Procedure: Computer guided surgery; Device: 2D cephalometric radiograph; Device: 3D computerized tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT03277443

292017

Details and patient eligibility

About

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

Full 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)

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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14 participants in 2 patient groups

Conventional Model Surgery

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional model surgery

Device: 2D cephalometric radiograph

Computer guided surgery

Experimental group

Description:

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.

Treatment:

Device: 3D computerized tomography

Procedure: Computer guided surgery