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Waferless One Stage Segmental Lefort I Maxillary Positioning in Transverse Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884699
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Rasha Anwar Ibrahim Taman, Cairo University

Brief Summary:

In Maxillary transverse deficiency, is waverless lefort I multiple pieces osteotomy using virtually planned patient specific titanium implants feasible and does it provide accuracy?

This prospective case series study evaluating the postoperative outcomes and accuracy of preoperatively planned positional changes together with virtually designed drilling and fixation guides for the waferless positioning and fixation of the multiple pieces Le Fort I of the maxilla using CAD-CAM designed patient-specific implants.

The purpose of this study is to develop and validate an orthognathic CAD/CAM patient specific implant together with template that can guide both the osteotomy and the repositioning of the maxilla during the correction of transverse maxillary deficiency.

Thus, the traditional model and the additional preparation for CAD/CAM surgical splints including scanning dental casts, and recording and moving virtual dental casts, were not required. The preoperative and laboratory procedures were simplified, and the intermediate splint technique was eliminated, so the associated potential errors were avoided.


Condition or disease Intervention/treatment Phase
Lefort I Osteotomy Procedure: Accuracy of planned transverse Maxillary distance using Mimics software after fixation using Patient specific implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accuracy of Waferless One Stage Segmental Lefort I Maxillary Positioning in Transverse Deficiency Using CAD/CAM Patient Specific Titanium Implants (Case Series Study)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Segmental maxillary lefort I re-positioning
Accuracy of the planned virtually re-positioned segmental Lefort I maxilla using a specifically designed patient implant, comparing the virtual plan to the actual postoperative position.
Procedure: Accuracy of planned transverse Maxillary distance using Mimics software after fixation using Patient specific implant

Virtual planning: based on clinical evaluation and 3D cephalometric analysis. Virtual osteotomies mimicking segmental Lefort I and a bilateral sagittal split osteotomy.

Designing the virtual cutting guide. Virtual movement into the desired positions of the segmented maxilla and mandible, based on: clinical evaluation, 3D cephalometric analysis and the desired occlusion.

Once the optimal position of the maxilla is achieved, a patient specific implant will be virtually designed to fix the segmented maxilla in its new position.

Fabrication of the cutting guide using additive manufacturing technique from polymer material.

Fabrication of PSI from titanium alloy using additive manufacturing technique.





Primary Outcome Measures :
  1. Transverse dimension of maxilla on virtual plan and postoperative [ Time Frame: 1-3 months ]

    8 Reference points will be chosen below the osteotomy line on the maxilla (4 dental and 4 bony), and the distances between these points and the Frankfort, the midfacial, and the coronal planes, to show the vertical, horizontal, and axial positions of the maxilla, respectively.

    These distances will be measured on the postoperative CT data and their deviations from the virtual plan will illustrate the accuracy of our procedure.

    The 4 bony reference points are :

    PF: Piriform at the widest point ; J: The junction between the maxillary tuberosity outline and the zygomatic process (63); and GPF: Greater palatine foramen.

    The 4 dental reference points are:

    A3L: Cusp of the left maxillary canine; A3R: Cusp of the right maxillary canine; A6L: Mesiobuccal cusp of the left first maxillary molar; and A6R: Mesiobuccal cusp of the right first maxillary molar.



Secondary Outcome Measures :
  1. Planning & surgical times: estimated time to the actual time [ Time Frame: 1-3 months ]
    Using chronometer, the time from the start of virtual plan & design, and the time of the surgery will be calculated.



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients suffering from transverse and anteroposterior maxillary discrepancy.
  • Patients requiring bimaxillary orthognathic surgery.
  • Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
  • Patients who will agree to the consent and will commit to follow-up period.
  • Highly motivated patients.

Exclusion Criteria:

  • Patients who are younger than 14 years.
  • Patients having a significant systemic disease that may affect normal healing.
  • Intra-bony lesions or infections that may retard the osteotomy healing.
  • Patients receiving chemo or radiotherapy.
  • Known allergies or sensitivities to dental materials, including Titanium or general anesthesia agents.
  • Patient with bad oral hygiene.
  • Pregnant females.
  • Inability to return for follow up visits.
  • Refusal of participation from the patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884699


Contacts
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Contact: Sherif Hassan, PhD 00201001932020 sherif.ali@dentistry.cu.edu.eg
Contact: Adel Abou-ElFetouh, PhD 00201018871899 ahfotouh@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Rasha Taman, Msc Cairo University
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Responsible Party: Rasha Anwar Ibrahim Taman, Assistant Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03884699    
Other Study ID Numbers: OMFS 3-3-7
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rasha Anwar Ibrahim Taman, Cairo University:
Orthognathic Surgery