Skip to main content
OpenTrials
Completed

NCT Number: NCT05385133

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Orthognathic Surgery

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer guided condylar position

Procedure

post-osteotomy condylar position was performed using patient specific surgical guides and pre-bent plates

Manual condylar position

Procedure

post-osteotomy condylar position was performed using the conventional manual method

Primary outcomes

  1. Condylar deviation

    Time frame: 1 week postoperatively

    Change of condyle position postoperative from preoperative position

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 23, 2022
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.