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Computer Guided for Mandibular Distraction Osteogenesis

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. Read our disclaimer for details. Identifier: NCT03869021
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Information provided by (Responsible Party):
Yasser Mohamed Nabil Ahmed Khirat El Hadidi, Ain Shams University

Brief Summary:

Objectives: Distraction Osteogenesis is an integral part in management of mandibular defects associated with Hemifacial Microsomia (HFM) and post-ankylotic mandibular defects. The most difficult part in distraction osteogenesis is the prediction of distraction vector and risk of injury to vital structures as inferior alveolar. The current study aimed to present Three-Dimensionally Constructed Computer Guided Splints in Distraction Osteogenesis to get an ideal vector and minimal risk of vital structures injury.

Methods: The study presents computer-guided distraction osteogenesis surgery using prefabricated splints.

Condition or disease Intervention/treatment Phase
Hemifacial Microsomia Other: 3D printed surgical guide constructed Other: free hand surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Case control trial
Masking: Double (Participant, Care Provider)
Masking Description: Single blinding
Primary Purpose: Other
Official Title: Technical Notes on Novel Technique and Step by Step Construction of Computer Guided for Mandibular Distraction Osteogenesis
Actual Study Start Date : December 30, 2015
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Arm Intervention/treatment
Active Comparator: Computer guided surgery
A surgical guide is 3d printed to guide through the surgery, the patients of this group will have the distraction surgery by a guide designed by Mimics 19.0, Materialise NV,Belgium
Other: 3D printed surgical guide constructed
A printed surgical guide ( to direct through the surgery and make results predictable), the guide is designed by Mimics 19.0, Materialise NV,Belgium and printed with self cure resin

No surgical guide (free hand surgery)
control group added to investigate the effect of surgical guide
Other: free hand surgery
A control group in which patients are randomly assigned and surgeries are planned without surgical guides and performed free handed

Primary Outcome Measures :
  1. Standard cephalometric parameters of cosmetic improvement will be assessed in Degree (0) unit [ Time Frame: 6 months ]
    The surgery of distraction osteogenesis is unpredictable the aim of use of computer planning is to make the surgery predictable to improve cosmetic results. the results will be by fixed radio graphic parameters as SNA, ANB to evaluate improvement in mandibular position, mandibular plane angle and smile orientation for occlusal cant assessment, H-angle and position of H-line to assess the retrognathia of chin all measurment will be done in degree unit

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Patients free from any disease affecting bone formation of both sexes was included in the study.
  2. Patients younger than 25 years old.
  3. Patients included in the study were hemifacial microsomia
  4. Distraction range was between 15-20 mm.

Exclusion Criteria:

  1. The presence of uncontrolled systemic disease.
  2. Previous radiotherapy on head and neck region.
  3. Chemotherapy within the past 12-month period.
  4. An active infection at the distraction site.

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 identifier (NCT number): NCT03869021

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Ain shams university
Cairo, Egypt, 11757
Sponsors and Collaborators
Yasser Mohamed Nabil Ahmed Khirat El Hadidi
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Principal Investigator: yasser el hadidi, mds Ain Shams University
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Responsible Party: Yasser Mohamed Nabil Ahmed Khirat El Hadidi, Assistant Lecturer, Ain Shams University Identifier: NCT03869021    
Other Study ID Numbers: 392B
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Yasser Mohamed Nabil Ahmed Khirat El Hadidi, Ain Shams University:
Computer guided surgery
Hemifacial Microsomia
Additional relevant MeSH terms:
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Goldenhar Syndrome
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes
Mandibulofacial Dysostosis
Craniofacial Dysostosis
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities