NCT03869021

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

March 1, 2019

Last Update Submit

March 7, 2019

Conditions

Hemifacial Microsomia

Keywords

Computer guided surgeryHemifacial Microsomia

Outcome Measures

Primary Outcomes (1)

  • Standard cephalometric parameters of cosmetic improvement will be assessed in Degree (0) unit

    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

    6 months

Study Arms (2)

Computer guided surgery

ACTIVE COMPARATOR

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

No surgical guide (free hand surgery)

OTHER

control group added to investigate the effect of surgical guide

Other: free hand surgery

Interventions

3D printed surgical guide constructedOTHER

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

Computer guided surgery
free hand surgeryOTHER

A control group in which patients are randomly assigned and surgeries are planned without surgical guides and performed free handed

No surgical guide (free hand surgery)

Eligibility Criteria

Age5 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, 11757, Egypt

Location

MeSH Terms

Conditions

Goldenhar Syndrome

Condition Hierarchy (Ancestors)

Mandibulofacial DysostosisCraniofacial DysostosisDysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • yasser el hadidi, mds

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Single blinding
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Case control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 11, 2019

Study Start

December 30, 2015

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

March 11, 2019

Record last verified: 2019-03

Locations

EG(1)