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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03277443
Enrollment
14
Registered
2017-09-11
Start date
2018-02-20
Completion date
2019-05-30
Last updated
2018-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apertognathia

Keywords

Skeletal open bite

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)

Interventions

PROCEDUREComputer 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

PROCEDUREConventional 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.

DEVICE2D cephalometric radiograph

2D cephalometric radiograph

DEVICE3D computerized tomography

3D computerized tomography

Sponsors

Ammar Ribhi Abu shama
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Intervention model description

SM and VSM

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of movement of surgical segments in millimeterup to 4 monthsComputer 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

MeasureTime frameDescription
Anterior open Bite Closure (positive overbite in millimeter)up to 4 monthsStandardized pre-surgery movement in amount of anterior open bite closure (mm) will be determined clinically and by radiograph.

Contacts

Primary ContactAmmar R Abu Shama, PHD
Dr.ammar.shama@gmail.com00201142354052
Backup ContactMamdouh S Sayed Ahmed, Professor
dr.mamdouhahmed@hotmail.com00201222173262

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026