Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201311000648184 Date of Approval: 20/09/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Conventional versus Computer-assisted techniques for reconstruction of orbitozygomatic fractures
Official scientific title Conventional versus Computer-assisted techniques for reconstruction of orbitozygomatic fractures: A Controlled clinical trial
Brief summary describing the background and objectives of the trial To assess the efficacy of recent CAD/CAM modalities in reconstruction of orbitozygomatic complex fractures compared to conventional free-hand techniques.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,orbital trauma, zygomatic fractures
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/03/2011
Actual trial start date 15/03/2011
Anticipated date of last follow up 30/06/2012
Actual Last follow-up date 30/09/2013
Anticipated target sample size (number of participants) 12
Actual target sample size (number of participants) 10
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Computer-Assisted Group Customized titanium meshes for orbital reconstruction and templates for zygomatic reduction 5
Control Group Coventional group Free-hand reduction of zygomatic fractures and adaptation of titanium meshes for orbital floor reconstruction 5 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Unilaterally displaced orbitozygomatic complex fractures. Cases indicated for internal orbital reconstruction. Patients where computed tomographies could not be obtained in DICOM format. 18 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/09/2009 Faculty of Oral & Dental Medicine Ethics Committee
Ethics Committee Address
Street address City Postal code Country
11 El-Saraya street, El-Manial Cairo 11451 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Orbital Volume Preoperative: after the orbital trauma has been sustained. Postoperative: 2 weeks after the orbital reconstruction surgery.
Secondary Outcome Enophthalmos Preoperative: after the orbital trauma has been sustained. Postoperative: 2 weeks after the orbital reconstruction surgery.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Oral & Maxillofacial Surgery Dept. - Cairo University 11 El-Saraya street, El-Manial Cairo 11451 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University El-Gamaa street, Bein El-Sarayat Cairo 12316 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oral & Maxillofacial Surgery Dept. - Cairo University 11 El-Saraya street, El-Manial Cairo 11451 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Maha Hakam 11 El-Saraya street, El-Manial Cairo 11451 Egypt
Dr. Adel Abou-ElFetouh 14 Mosaddak street, Dokki Giza 12311 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yasmine Nassar yasmine.nassar@dentistry.cu.edu.eg +20-111-4887779 107 Abdul-Aziz Al-Saoud street, El-Manial
City Postal code Country Position/Affiliation
Cairo 11451 Egypt Lecturer, Oral & Maxillofacial Surgery Dept. - Cairo University
Role Name Email Phone Street address
Public Enquiries Adel Abou-ElFetouh a.abouelfetouh@dentistry.cu.edu.eg +20-111-4408950 14 Mosaddak street, Dokki - Flat #1
City Postal code Country Position/Affiliation
Giza 12311 Egypt Lecturer, Oral & Maxillofacial Surgery Dept. - Cairo University
Role Name Email Phone Street address
Scientific Enquiries Adel Abou-ElFetouh a.abouelfetouh@dentistry.cu.edu.eg +20-111-4408950 14 Mosaddak street, Dokki - Flat #1
City Postal code Country Position/Affiliation
Giza 12311 Egypt Lecturer, Oral & Maxillofacial Surgery Dept. - Cairo University
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information