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

February 13, 2018 updated by: Ammar Ribhi Abu shama

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Conventional Model Surgery

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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of movement of surgical segments in millimeter
Time Frame: 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).
up to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior open Bite Closure (positive overbite in millimeter)
Time Frame: up to 4 months
Standardized pre-surgery movement in amount of anterior open bite closure (mm) will be determined clinically and by radiograph.
up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ammar Ribhi Abu shama

Investigators

  • Study Director: Moustafa K Ezz, Professor, Cairo university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 20, 2018

Primary Completion (ANTICIPATED)

December 30, 2018

Study Completion (ANTICIPATED)

May 30, 2019

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (ACTUAL)

September 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 292017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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