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.: PACTR201702001929154 Date of Approval: 23/12/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Patient Satisfaction of orbital prosthesis fabricated by aid of rapid prototyping technology versus conventional technique in orbital defect patients
Official scientific title Patient Satisfaction of orbital prosthesis fabricated by aid of rapid prototyping technology versus conventional technique in orbital defect patients
Brief summary describing the background and objectives of the trial Orbital defects are considered one of the most challenging defects to be restored prosthetically regarding esthetics . the comventional technique is a time consuming process which depends on exceptional artistic talent to make a mirror image of the healthy side.The 3D scanning technologies and computer aided designing and rapid prototyping have been reported to overcome the conventional method issues, but were not tested in a randomized trial for significant changes in patient`s satisfaction and dimensional accuracy.the aim of the study is to compare between orbital prosthesis fabricated by the aid of rapid prototyping technology versus orbital prosthesis fabricated by conventional technique from the point of patient satisfaction, dimensional accuracy and chair-side time through a cross over randomized clinical trial.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied orbital defect patients due to cancer removal surgery, trauma,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2017
Actual trial start date
Anticipated date of last follow up 01/08/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 8
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Crossover: all participants receive all interventions in different sequence during study Randomised computer-generated two column tables of random numbers using www.random.org allocation will be done by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group orbital prothesis made by conventional technique will be done once will be worn for 3 months an impression of the orbital defect will be made, then a suitable stock eye shell will be selected and waxing up of the major anatomy will be carried out. After adding fine details and texture to the wax, the skin shade will be selected and the prosthesis will be processed in room vulcanized silicone. Finally the prosthesis will be colored by extrinsic colors 8
Experimental Group orbital prosthesis fabricated by aid of rapid prototyping technology will be done once will be worn for 3 months an impression of the orbital defect will be made, and then the patient will be sent to be scanned by (Planmeca ProMax 3D ProFace). After obtaining the patient`s STL file, a design of the final prosthesis will be done on a specialized software guided by the data from the intact side, then will be prototyped. The rapid prototyping model of the prosthesis will be duplicated in wax and then fine detai 8
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Orbital resection defects -The bony walls of the orbit should be lined with skin - The patients should be systematically free - The patients should be cooperative and committed to maintain prosthesis -Orbital defects occluded by local or distant tissue flap. - Orbital defects where lids were retained. - Patients with recent surgical intervention in the orbit (within at 6 months). - Patients subjected to radiotherapy. - Patients with serious systemic problems or conditions (including psychiatric disease). 8 Year(s) 80 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
No 31/12/2016 Research Ethics Committee Cairo University Faculty of Oral and Dental Medicine
Ethics Committee Address
Street address City Postal code Country
11 Al Sarai Street, Al Menial cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome patient satisfaction -T1 : after 3 weeks from prosthesis delivery - T2 :after 3 months
Secondary Outcome Dimensional accuracy of the prothesis at time of delivery of the prosthesis
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Cancer Institute Kornish El-Nile - Fom El- Khaleg cairo 11796 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sara eman saad el din 25 bitcho city,zahraa maadi maadi 002 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Ashraf emil esknder 11 Al Sarai Street, Al Menial cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sara Eman Saad El-din Sarah.eman90@gmail.com +20201010858060 25 Bitcho city-Zahraa El Maadi Street
City Postal code Country Position/Affiliation
cairo 002 Egypt Master candidate
Role Name Email Phone Street address
Public Enquiries Sara Eman Saad El-din Sarah.eman90@gmail.com +20201001689901 25 Bitcho city-Zahraa El Maadi Street
City Postal code Country Position/Affiliation
cairo 002 Egypt Master candidate
Role Name Email Phone Street address
Scientific Enquiries Khaled Aziz Kaledaziz78@gmail.com +20201001689901 Lebanon square-Al Agouzah street
City Postal code Country Position/Affiliation
Giza 002 Egypt Assistant professor at removableprosthodontics department- cairo university
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information