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

Sponsor

Ammar Ribhi Abu shama (Other)

Overall Status

Unknown status

CT.gov ID

NCT03277443

Collaborator

(none)

Enrollment

Arms

15.2

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Apertognathia	Procedure: Computer guided surgery Procedure: Conventional model surgery Device: 2D cephalometric radiograph Device: 3D computerized tomography	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

SM and VSMSM and VSM

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 20, 2018

Anticipated Primary Completion Date :

Dec 30, 2018

Anticipated Study Completion Date :

May 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional Model Surgery 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 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. Device: 2D cephalometric radiograph 2D cephalometric radiograph
Experimental: 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.	Procedure: 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 Device: 3D computerized tomography 3D computerized tomography

Arm

Intervention/Treatment

Active Comparator: Conventional Model Surgery

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

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.

Device: 2D cephalometric radiograph

2D cephalometric radiograph

Experimental: 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.

Procedure: 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

Device: 3D computerized tomography

3D computerized tomography

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ammar Ribhi Abu shama

Investigators

Study Director: Moustafa K Ezz, Professor, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ammar Ribhi Abu shama, PHD Doctor in Oral and Maxillofacial Surgery, Cairo University

ClinicalTrials.gov Identifier:

NCT03277443

Other Study ID Numbers:

292017

First Posted:

Sep 11, 2017

Last Update Posted:

Feb 14, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ammar Ribhi Abu shama, PHD Doctor in Oral and Maxillofacial Surgery, Cairo University

Skeletal open bite

Additional relevant MeSH terms:

Open Bite

Study Results

No Results Posted as of Feb 14, 2018