Condyle Repositioning Using PSI and Prebent Plates Osteosynthesis Versus Conventional Mandibular BSSO Set-back Surgery

Not Applicable

Completed

• Conditions: Orthognathic Surgery
• Interventions: Procedure: Manual condylar position; Procedure: Computer guided condylar position

• Registration Number: NCT05385133
• Lead Sponsor: Cairo University

Brief Summary

Patients with skeletal class III malocclusion were allocated to two groups. Both proximal and distal segments were repositioned using osteotomy/screw holes and plate locating surgical guides with pre-bent plates osteosynthesis in the intervention group, while manual free hand condylar segment seating was used for proximal segment positioning in the control group.

Detailed Description

Twenty patients with skeletal class III malocclusion were randomly allocated to two groups. Both proximal and distal segments were repositioned using osteotomy/screw holes and plate locating surgical guides with pre-bent plates osteosynthesis in the intervention group, while manual free hand condylar segment seating was used for proximal segment positioning in the control group. Accuracy of condylar position was assessed using computed tomography.

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2022-01-20
• Study Completion: 2022-01-20
• Status Verified: 2022-05
• Study First Submitted: 2022-05-07
• Study First Submitted QC: 2022-05-19
• Last Update Submitted: 2022-05-19
• Study First Posted: 2022-05-23
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult patients complaining of skeletal class III malocclusion that require BSSO for correction of their deformity

Exclusion Criteria

• Patients require bi-maxillary orthognathic surgery
• patients with temporomandibular joint dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual condylar position	Manual condylar position	post-osteotomy condylar position was performed using the conventional free hand approach
Computer guided condylar position	Computer guided condylar position	post-osteotomy condylar position was performed using patient specific surgical guides and pre-bent plates

Primary Outcome Measures

Name	Time	Method
Condylar deviation	1 week postoperatively	Change of condyle position postoperative from preoperative position

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Egypt