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

Not Applicable

• Conditions: Skeletal Abnormalities
• Interventions: Other: Bilateral Sagittal Split Osteotomy

• Registration Number: NCT03983265
• Lead Sponsor: Cairo University

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 .

Study Timeline

• Study Start: 2018-11-20
• Status Verified: 2019-06
• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-10
• Last Update Submitted: 2019-06-10
• Study First Posted: 2019-06-12
• Last Update Posted: 2019-06-12
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
computer guided condylar reposition device	Bilateral Sagittal Split Osteotomy	surgical procedure : under general anesthesia after BSSO condyle will be repositioned by computer guided repostioning device

Primary Outcome Measures

Name	Time	Method
accuracy of postoperative condylar position in relation to the corrected virtual model	immediate postoperative	the accuracy of postoperative condylar position will be assessed using Mimics soft ware ,measuring unit (mm)

Secondary Outcome Measures

Name	Time	Method
operative time	during operation	surgical time will be assessed via clinical assessment measuring unit (hours)

Trial Locations

Locations (1)

oral and dental medicine Cairo university; 🇪🇬 Giza, Egypt