Back to resultsAccuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite
Primary Purpose
Apertognathia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computer guided surgery
Conventional model surgery
2D cephalometric radiograph
3D computerized tomography
Sponsored by
About this trial
This is an interventional treatment trial for Apertognathia focused on measuring Skeletal open bite
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Model Surgery
Computer guided surgery
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03277443
First Posted
September 6, 2017
Last Updated
February 13, 2018
Sponsor
Ammar Ribhi Abu shama
1. Study Identification
Unique Protocol Identification Number
NCT03277443
Brief Title
Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite
Official Title
Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2018 (Anticipated)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
May 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ammar Ribhi Abu shama
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apertognathia
Keywords
Skeletal open bite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
SM and VSM
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional Model Surgery
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Computer guided surgery
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Computer guided surgery
Intervention Description
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
Intervention Name(s)
Conventional model surgery
Intervention Description
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
Device
Intervention Name(s)
2D cephalometric radiograph
Intervention Description
2D cephalometric radiograph
Intervention Type
Device
Intervention Name(s)
3D computerized tomography
Intervention Description
3D computerized tomography
Primary Outcome Measure Information:
Title
Accuracy of movement of surgical segments in millimeter
Description
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).
Time Frame
up to 4 months
Secondary Outcome Measure Information:
Title
Anterior open Bite Closure (positive overbite in millimeter)
Description
Standardized pre-surgery movement in amount of anterior open bite closure (mm) will be determined clinically and by radiograph.
Time Frame
up to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ammar R Abu Shama, PHD
Phone
00201142354052
Email
Dr.ammar.shama@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mamdouh S Sayed Ahmed, Professor
Phone
00201222173262
Email
dr.mamdouhahmed@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moustafa K Ezz, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite
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