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OpenTrials
Completed

NCT Number: NCT06772688

Custom Made Plate in Orthognathic Surgery

Orthognathic surgery has traditionally been used to correct dentofacial deformities. Conventional methods rely on 2D radiographic images, occlusal splints, and dental casts, but these approaches have limitations, such as errors during face-bow transfer. Technological advancements, including 3D imaging, virtual surgical planning (VSP), and computer-aided design and manufacturing (CAD/CAM), have improved the precision and outcomes of orthognathic surgery.

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Key information

Conditions

Maxillary Prognathism Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Mandibular Diseases Maxillary Retrusion Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Retrognathia Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dental medicine Azhar university

Cairo, 12345, Egypt

About this study

This study included one group of patients need orthognathic surgery and fixation of maxilla using custom made plate designed by 3D virtual planning using Materialize mimic soft ware

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with skeletal class II or class III who need orthognathic surgery.
  • Patients who suffer from clinical facial asymmetry.
  • Patients with occlusal plane canting.
  • Age range of patients 18-40 years old, with no gender prediction, able to read and sign the informed consent.

Exclusion criteria

  • Maxillofacial trauma
  • Patients who suffer from maxillofacial tumors
  • Segmental maxillary surgery.
  • Oral soft tissues defects, infections and bone metabolism disturbance.
  • Allergy to titanium implant.
  • Patient with systemic disease and immunocompromised patient.

Treatment and study plan

Orthognathic Surgery

Procedure

Maxillary repositioning and fixation with custom made plate

Primary outcomes

  1. Evaluation of the accuracy of custom-made plate

    Time frame: immediate postoperative

    CT to measure the accuracy

Sponsors and collaborators

Lead sponsor

Faculty of Dental Medicine for Girls

Other Gov

Registry information

Official study title

Evaluation of the Accuracy of Custom-made Plate in Maxillary Repositioning

Acronym: OGS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2025
Registry last updated
Jan 17, 2025

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.

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