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

Orthognathic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05385133
• Other study ID #: OMFS-14719
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 20, 2022

Study information

• Verified date: May 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Orthognathic Surgery

Intervention

Procedure:
• Computer guided condylar position
post-osteotomy condylar position was performed using patient specific surgical guides and pre-bent plates
• Manual condylar position
post-osteotomy condylar position was performed using the conventional manual method

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Condylar deviation	Change of condyle position postoperative from preoperative position	1 week postoperatively