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

Skeletal Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03983265
• Other study ID #: ymmustafa
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2018
• Est. completion date: January 2020

Study information

• Verified date: June 2019
• Source: Cairo University
• Contact: yara mamdouh mustafa, BDS
• Phone: 01002955632
• Email: yara.mustafa[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Skeletal Abnormalities

Intervention

Other:
• Bilateral Sagittal Split Osteotomy
after BSSO condyle will be re positioned by using computer guided device

Locations

Country	Name	City	State
Egypt	oral and dental medicine Cairo university	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	operative time	surgical time will be assessed via clinical assessment measuring unit (hours)	during operation

External Links

•   A novel method for the management of proximal segment using computer assisted simulation surgery: correct condyle head positioning and better proximal segment placement
•   Clinical and radiographic evaluation of a computer-generated guiding device in bilateral sagittal split osteotomies
•   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