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

NCT03983265 | Unknown DMC

• 1 other identifier: ymmustafa
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Skeletal Abnormalities

Outcome Measures

Primary Outcomes (1)

• 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)

  immediate postoperative

Secondary Outcomes (1)

• operative time

  during operation

Study Arms (1)

computer guided condylar reposition device

OTHER

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

Other: Bilateral Sagittal Split Osteotomy

Interventions

Bilateral Sagittal Split Osteotomy OTHER

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

computer guided condylar reposition device

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

oral and dental medicine Cairo university

Giza, 12613, Egypt

RECRUITING

Related Links

• Computer-assisted orthognathic surgery: feasibility study using multiple CAD/CAM surgical splints
• Orthognathic Positioning System: Intraoperative System to Transfer Virtual Surgical Plan to Operating Field During Orthognathic Surgery
• Clinical and radiographic evaluation of a computer-generated guiding device in bilateral sagittal split osteotomies
• A novel method for the management of proximal segment using computer assisted simulation surgery: correct condyle head positioning and better proximal segment placement

Study Officials

• Mohammed omara, Lecturer

  faculty of oral and dental medicine Cairo university

  STUDY DIRECTOR

Central Study Contacts

yara mamdouh mustafa, BDS

CONTACT

01002955632; yara.mustafa@dentistry.cu.edu.eg

yara mamdouh mustafa, BDS

CONTACT

0100295532; yara.mustafa@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

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

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 12, 2019
• Study Start: November 20, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)