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

December 18, 2023 updated by: Alexandria University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21619
        • Alexandria University, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with acute infection at surgery site.
  2. Patient with Systemic disorders contraindicating surgery.
  3. Smokers.
  4. Alcohol or drug abuse is prohibited.
  5. patients who suffered from craniofacial syndrome.
  6. patients who had previous orthognathic surgery.
  7. patients who had previous maxillary or mandibular trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: (group one) will be treated with custom titanium plates and guide to reposition the maxilla
7 patients are included in this arm. Le Fort I osteotomy using CAD CAM surgical guide and 3Dcustomized plate are placed to reposition the maxilla according to the virtual surgical planning.
Procedure: Orthognathic surgery (lefort1)
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
Active Comparator: (group 2) will be treated with prebent titanium plates
7 patients are included in this arm. le fort 1 osteotomy using surgical guide and pre-bent stock titanium plates are used after their adaptation on the model of postoperative plan.
Procedure: Orthognathic surgery (lefort1)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

October 20, 2023

Study Registration Dates

First Submitted

December 9, 2023

First Submitted That Met QC Criteria

December 18, 2023

First Posted (Estimated)

January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Orthognathic2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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