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OpenTrials
Completed

NCT Number: NCT06188403

Comparison Between Prebent Plates and Custom Plates After le Fort 1 in Orthognathic Surgery

patients with dentofacial deformities , who needs lefort 1 osteotomy to correct position of maxilla , are divided into two groups: one group receives custom titanium plates which is patient specific and the other group receives prebent titanium plates done on printed postop plan model before surgery.

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Key information

Conditions

Orthognathic Surgery

Age range

18 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University, Faculty of dentistry

Alexandria, 21619, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • . Patients with non-syndromic dentofacial deformity requiring Le Fort I with or without bimaxillary osteotomy.

Exclusion criteria

  • Patients with acute infection at surgery site.
  • Patient with Systemic disorders contraindicating surgery.
  • Smokers.
  • Alcohol or drug abuse is prohibited.
  • patients who suffered from craniofacial syndrome.
  • patients who had previous orthognathic surgery.
  • patients who had previous maxillary or mandibular trauma

Treatment and study plan

Orthognathic surgery (lefort1)

Procedure

Lefort 1 osteotomy to reposition the maxilla using two different techniques to achieve more accurate results , one with guide for cutting and placing pre bent stock plates and the other method using custom titanium plates with guide for cutting and placing the plate

Other names: Dentofacial surgery

Primary outcomes

  1. Radiographic accuracy between postoperative plan and postoperative result.

    Time frame: one month

    Cone Beam Computed tomography (CBCT) is used at 1 month to assess surgical outcome by comparing the clinical results with the virtually planned outcome.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Comparison of Radiographic Accuracy Between Pre-bent Titanium Plates and 3D Customized Titanium Plates After le Fort 1 Osteotomy in Orthognathic Surgery

Acronym: customortho

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2024
Registry last updated
Jan 3, 2024

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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