Condylar Segment Repositioning Using CAD/CAM Generated Wafer After BSSO in Skeletal Mandibular Deformity

June 10, 2019 updated by: yara mamdouh mustafa, Cairo University

Condylar/Proximal Segments Repositioning Using CAD/CAM Generated Wafer After Bilateral Sagittal Split Osteotomy in Skeletal Mandibular Deformity

Maintaining the condylar position after bilateral sagittal split ramus osteotomy (BSSO) is one of the most important aspects in terms of condylar function ,.An altered condylar position can cause internal derangement of the joint, loss of the mandibular angle, increased risk of relapse, condyle sagging, and impaired masticatory function.

In previous years, a great deal of attention has been paid to maintaining the preoperative condylar position during orthognathic surgery. Numerous condylar positioning methods have been reported and could be divided into manual/empirical methods, conventional methods , navigation, and sonographic monitoring, Computer guided methods which is more accurate than other methods

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

unpredictable condylar position after orthognathic surgery, will lead to malocclusion, derangement of the condylar surface, condylar resorption, condylar sag, distraction of the condyles from the fosse. In previous years, several authors had been adopted several techniques to maintain the preoperative condylar position during orthognathic surgery. Numerous condylar positioning methods have been reported which could be divided into conventional techniques (manual maneuvers or aiding tools), Extra and intra oral navigational techniques , surgeons had been utilized these techniques in condylar repositiong after BSSO but it was time and effort consuming and sometimes it was inaccurate. the aim for conducting the research is accurate positioning of condyle three dimensionally to minimize effort and operating time of surgery .

Study Type

Interventional

Enrollment (Anticipated)

10

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.

Study Locations

  • Egypt
      • Giza, Egypt, 12613
        • Recruiting
        • oral and dental medicine Cairo university
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohammed omara, Lecturer

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of the patient above 18 years
  • Patients needs bilateral sagittal split osteotomy
  • All patients are free from any systemic disease that may affect normal bone healing
  • Sufficient dentition to reproduce the occlusal relationships
  • Patient's consent to participate

Exclusion Criteria:

  • Patient with TMJ Disorders
  • Patients with any systemic disease that may affect normal healing
  • Intra-bony lesions or infections that may interfere with surgery.the presence of
  • Previous orthognathic surgeries

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: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: computer guided condylar reposition device
surgical procedure : under general anesthesia after BSSO condyle will be repositioned by computer guided repostioning device
Other: Bilateral Sagittal Split Osteotomy
after BSSO condyle will be re positioned by using computer guided device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of postoperative condylar position in relation to the corrected virtual model
Time Frame: immediate postoperative
the accuracy of postoperative condylar position will be assessed using Mimics soft ware ,measuring unit (mm)
immediate postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: during operation
surgical time will be assessed via clinical assessment measuring unit (hours)
during operation

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: Mohammed omara, Lecturer, Faculty of Oral and Dental Medicine Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (ACTUAL)

November 20, 2018

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

January 1, 2020

Study Registration Dates

First Submitted

June 7, 2019

First Submitted That Met QC Criteria

June 10, 2019

First Posted (ACTUAL)

June 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 12, 2019

Last Update Submitted That Met QC Criteria

June 10, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ymmustafa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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