amount of volume increase of the mid-facial area affected by polyethylene prosthesis
Design
Clinical Trial without control group
Patients are all grouped into a group and the same procedure and similar prosthesis are used
Settings and conduct
These surgeries are carried out at BouAli Hospital in Tehran and by a single surgeon
Surgery is under general anesthesia and the prosthesis are placed in the appropriate place on over zygomatic bone using oral incisions and the prostheses are fixed to the bone by a titanium screw
Participants/Inclusion and exclusion criteria
Patients requiring surgical prosthetics referring to Boouli Hospital
Patients should be free of systemic diseases, which are classified as ASA1 or ASA2
Patients have no history of previous surgery or trauma to the head and neck
Patients who have an infection or displacement of the prosthesis after surgery are excluded
Patients who have BMI changes in excess of one unit during the follow-up period are excluded
Intervention groups
The intervention involves the insertion of a polyethylene prosthesis onto a person's zygomatic bone
This surgery is performed under general anesthesia via intraoral approach
The registration of the three-dimensional shape of the face before and after the operation is performed by a three-dimensional scanner with a Structural Light system that does not cause any radiation or injury to the patient
Main outcome variables
volume changes in the malar and buccal regions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180515039664N1
Registration date:2018-05-28, 1397/03/07
Registration timing:prospective
Last update:2018-05-28, 1397/03/07
Update count:0
Registration date
2018-05-28, 1397/03/07
Registrant information
Name
Sina Hakimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 9626
Email address
sinahakimi@irimc.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of polyethylene prosthesis surgery on volume changes in mid-facial area in bouali hospital patients by 3D scanner
Public title
Evaluation of the effect of polyethylene prosthesis on volume changes in mid-facial area
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients requiring surgical prosthetics referring to Boouli Hospital
No systemic disease limiting ASA1 or ASA2 classifications
No history of surgery or trauma in the head and neck area
Exclusion criteria:
Infection or displacement of the prosthesis after surgery
BMI changes over one unit in the follow-up period
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Azad University of Medical Science
Street address
No. 4, 9th Neyestan St., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.IAU.DENTAL.REC.1395,29
Health conditions studied
1
Description of health condition studied
Midface Deficiency
ICD-10 code
Q18.9
ICD-10 code description
Congenital malformation of face and neck, unspecified
Primary outcomes
1
Description
volume of the midfacial area
Timepoint
Measuring the volume of the face will be done before surgery and 5 months after surgery
Method of measurement
3D scanner device Structured Light (Sense™, 3D Systems Inc, Rock Hill, USA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Surgical placement of polyethylene prosthesis Design M Malar Implants(MEDPOR MEDPOR™, Porex Surgical Inc, Newnan USA) Small 9507 و 9508 (64mm19mm3mm) and 3D scan of face surface
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali Hospital
Full name of responsible person
Sina Hakimi
Street address
Damavand Ave., Imam Hossein Sq.
City
Tehran
Province
Tehran
Postal code
۱۹۸۸۶۴۴۶۵۶
Phone
+98 21 3331 1107
Email
sinahakimi@irimc.org
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Arash Azizi
Street address
No. 4, 9th Neyestan St., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 3331 1107
Email
sinahakimi@irimc.org
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sina Hakimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Maxillofacial Surgery
Street address
No. 4, 9th Neyestan St., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 3331 1107
Email
sinahakimi@irimc.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sina Hakimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Maxillofacial Surgery
Street address
No. 4, 9th Neyestan St., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 3331 1107
Email
sinahakimi@irimc.org
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sina Hakimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Maxillofacial Surgery
Street address
No. 4, 9th Neyestan St., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 3331 1107
Email
sinahakimi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In the initial form, personal information including name and surname and age, height and weight are recorded and a number assigned to each person
The face scan information of each patient is stored to the computer
with the name assigned
After being unidentifiable, only the information on the main outcome is shared
When the data will become available and for how long
Starting data access is 6 months after the results are printed
To whom data/document is available
All people with a medical degree or working in health care organizations
Under which criteria data/document could be used
Any data analysis is allowed
From where data/document is obtainable
Applicants will submit their application in the order of priority to the following emails
sinahakimi@irimc.org
sinahakimi@yahoo.com
thehakimi24@gmail.com
What processes are involved for a request to access data/document
After receiving an request email, the datas will be sent within 5 to 7 days