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

Apertognathia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03277443
• Other study ID #: 292017
• Status: Not yet recruiting
• Phase: N/A
• First received: September 6, 2017
• Last updated: February 13, 2018
• Start date: February 20, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: February 2018
• Source: Cairo University
• Contact: Ammar R Abu Shama, PHD
• Phone: 00201142354052
• Email: Dr.ammar.shama[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 14
• Est. completion date: May 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apertognathia
• Open Bite

Intervention

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
• 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
• 3D computerized tomography
3D computerized tomography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ammar Ribhi Abu shama

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	up to 4 months
Secondary	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.	up to 4 months