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

Primary Purpose

Skeletal Abnormalities

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Bilateral Sagittal Split Osteotomy

About this trial

This is an interventional other trial for Skeletal Abnormalities

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

oral and dental medicine Cairo universityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

computer guided condylar reposition device

Arm Description

surgical procedure : under general anesthesia after BSSO condyle will be repositioned by computer guided repostioning device

Outcomes

Primary Outcome Measures

accuracy of postoperative condylar position in relation to the corrected virtual model

the accuracy of postoperative condylar position will be assessed using Mimics soft ware ,measuring unit (mm)

Secondary Outcome Measures

operative time

surgical time will be assessed via clinical assessment measuring unit (hours)

Full Information

NCT ID

NCT03983265

First Posted

June 7, 2019

Last Updated

June 10, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03983265

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 20, 2018 (Actual)

Primary Completion Date

January 2020 (Anticipated)

Study Completion Date

January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skeletal Abnormalities

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

computer guided condylar reposition device

Arm Type

Other

Arm Description

surgical procedure : under general anesthesia after BSSO condyle will be repositioned by computer guided repostioning device

Intervention Type

Other

Intervention Name(s)

Bilateral Sagittal Split Osteotomy

Intervention Description

after BSSO condyle will be re positioned by using computer guided device

Primary Outcome Measure Information:

Title

accuracy of postoperative condylar position in relation to the corrected virtual model

Description

the accuracy of postoperative condylar position will be assessed using Mimics soft ware ,measuring unit (mm)

Time Frame

immediate postoperative

Secondary Outcome Measure Information:

Title

operative time

Description

surgical time will be assessed via clinical assessment measuring unit (hours)

Time Frame

during operation

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

yara mamdouh mustafa, BDS

Phone

01002955632

yara.mustafa@dentistry.cu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

yara mamdouh mustafa, BDS

Phone

0100295532

yara.mustafa@dentistry.cu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammed omara, Lecturer

Organizational Affiliation

faculty of oral and dental medicine Cairo university

Official's Role

Study Director

Facility Information:

Facility Name

oral and dental medicine Cairo university

City

Giza

ZIP/Postal Code

12613

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

yara mamdouh, BDS

Phone

01002955632

yara.mustafa@dentistry.cu.edu.eg

First Name & Middle Initial & Last Name & Degree

Mohammed omara, PHD

Phone

01144452862

omara_mohammed@ymail.com

First Name & Middle Initial & Last Name & Degree

Mohammed omara, Lecturer

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/22668627

Description

Computer-assisted orthognathic surgery: feasibility study using multiple CAD/CAM surgical splints

URL

https://www.ncbi.nlm.nih.gov/pubmed/23312847

Description

Orthognathic Positioning System: Intraoperative System to Transfer Virtual Surgical Plan to Operating Field During Orthognathic Surgery

URL

https://www.ncbi.nlm.nih.gov/pubmed/24099655

Description

Clinical and radiographic evaluation of a computer-generated guiding device in bilateral sagittal split osteotomies

URL

https://www.ncbi.nlm.nih.gov/pubmed/26258114

Description

A novel method for the management of proximal segment using computer assisted simulation surgery: correct condyle head positioning and better proximal segment placement

Learn more about this trial

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

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