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

Condyle Repositioning Using Patient Specific Guides and Prebent Plates Osteosynthesis Versus Conventional Mandibular Bilateral Sagittal Split Osteotomy Set-back Surgery: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Orthognathic Surgery
• Intervention / Treatment: Procedure: Computer guided condylar position; Procedure: Manual condylar position

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computer guided condylar position; post-osteotomy condylar position was performed using patient specific surgical guides and pre-bent plates	Procedure: Computer guided condylar position; post-osteotomy condylar position was performed using patient specific surgical guides and pre-bent plates
Experimental: Manual condylar position; post-osteotomy condylar position was performed using the conventional free hand approach	Procedure: Manual condylar position; post-osteotomy condylar position was performed using the conventional manual method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Condylar deviation	Change of condyle position postoperative from preoperative position	1 week postoperatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): January 20, 2022
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: May 7, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: OMFS-14719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No