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Completed

NCT Number: NCT06317012

Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery

Background: In orthognathic surgery, virtual planning is gradually taking over in clinical practice. To start with, virtual surgery planning (VSP) is believed to be less time-consuming and less expensive than conventional surgery planning (CSP). Moreover, the improved visualization of craniofacial deformities, such as occlusal canting and asymmetries, is a further advantage. Aim: To assess the result of Le Fort I osteotomy using CAD/CAM and 3Dcustomized titanium plate with virtual planning in orthognathic surgery. Materials and Methods: 8 patients with vertical maxillary excess will be included in the study. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate will be done for the study group. All patients will be followed clinically and radiographically for one month.

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Key information

Conditions

Le Fort; I

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with non-syndromic dentofacial deformity requiring isolated Le Fort I with or without bimaxillary osteotomy.
  • Patients with good oral hygiene.
  • Class II or III malocclusion.
  • Patients who were scheduled to undergo a CT scan as a part of their diagnosis and treatment

Exclusion criteria

  • Patients with acute infection at the 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

Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate

Procedure

Le Fort I osteotomy will be performed with the aid of a surgical guide through the mucosal incision at the maxillary vestibule region, providing adequate surgical exposure.

The planned position will be obtained using a customized titanium plate for precise maxillary position and fixation as planned virtually on the software.

Primary outcomes

  1. Change in pain

    Time frame: 2nd and 7th days

    pain will be scored using visual analogue scale. it ranges from 0 to 10, 0 mean no pain and 10 means severe pain

  2. change in edema

    Time frame: 2nd and 7th days

    it was evaluated by its ability to pit. The examiner's fingers will press into the dependent area for 5 seconds, and the pitting will be graded on a scale of +1 to+4.

  3. Change in post operative osteotomy position

    Time frame: Immediate post operative

    Computed tomography (CT) will be used immediately postoperative to assess surgical position by comparing the clinical results with the virtually planned outcome.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Assessment Of Computer-Aided Design/Manufacturing for Le Fort I Osteotomy and 3D-customized Titanium Plate in Orthognathic Surgery (Clinical Trial)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 19, 2024
Registry last updated
Mar 19, 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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