Nasal Soft Tissue Changes Following Maxillary Lefort I Advancement Osteotomy with and without Impaction ; using 3D Photogrammetry, A before and after Clinical Trial
Determination of Nasal Soft Tissue Changes following Maxillary Lefort I Advancement, Determination of Nasal Soft Tissue Changes following Maxillary Lefort I Advancement with Impaction, َAnd then Comparison of these two Parameters.
Design
Two arm parallel group not randomised clinical trial without Blinding, In 21 Patients
Settings and conduct
Patients undergoing orthognathic surgery in Ayatollah Taleghani and Farmaniyeh hospitals in Tehran. Three-dimensional images are going to obtain from patients by 3D optical Scanner pre-operation and 4 months post-operation.
Participants/Inclusion and exclusion criteria
Patients will undergo Maxillary Lefort I Advancement Osteotomy With and Without Impaction
Intervention groups
Group I : 11 Patients are going to treat by Maxillary Lefort I Advancement osteotomy only.
Group II: 10 Patients are going to treat by Maxillary Lefort I advancement with Impaction Osteotomy
Main outcome variables
Nasal Soft Tissue Changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200726048214N1
Registration date:2020-09-12, 1399/06/22
Registration timing:retrospective
Last update:2020-09-12, 1399/06/22
Update count:0
Registration date
2020-09-12, 1399/06/22
Registrant information
Name
Hamoun Sabri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3345 0736
Email address
hamounsbi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-22, 1398/05/31
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
2019-08-22, 1398/05/31
Actual recruitment end date
2020-07-21, 1399/04/31
Trial completion date
2020-07-21, 1399/04/31
Scientific title
Nasal Soft Tissue Changes Following Maxillary Lefort I Advancement Osteotomy with and without Impaction ; using 3D Photogrammetry, A before and after Clinical Trial
Public title
Nasal Changes Following Maxillary Advancement with and without Impaction, Using 3D imaging
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Class III Malocclusion, Candidate for Lefort I Maxillary Advancement With or without Maxillary Impaction Surgery.
Exclusion criteria:
Congenital diseases
Cleft lip and palate and other syndromes
history of facial trauma
previous orthognathic surgery
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
21
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti Medical Sciences University
The soft tissue variables will be extracted from the 3D images taken by the 3D face scanner and then their numerical values will be calculated by GOM Inspect 2019 software.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Maxillary Lefort I advancement Osteotomy without Impaction, Patients will undergo conventional Maxillary Lefort I advamcement surgery without Impaction . 3D images of patient's faces before surgery and 4 months after surgery will be taken by a 3D Optical scanner.
Category
Treatment - Surgery
2
Description
Intervention group: Maxillary Lefort I advancement with Impaction Osteotomy, Patients will undergo conventional Maxillary Lefort I advamcement with Impaction surgery . 3D images of patient's faces before surgery and 4 months after surgery will be taken by a 3D light scanner.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Farmanieh Hospital
Full name of responsible person
Hamoun Sabri
Street address
No 20 Andarzgoo Blvd, Shemiranat, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1578652369
Phone
+98 21 2815 2000
Email
webmail@farmaniehhospital.com
Web page address
http://farmanieh-hospital.com/fa/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzin Sarkarat
Street address
Sarkarat clinic, Kaveh Blvd, district 3, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2239 4855
Email
sarkarat@hotmail.com
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
80
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamoun Sabri
Position
Student, Faculty of Dentistry
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 23 Amid St, Zaferanieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985955817
Phone
+98 21 2241 1626
Email
Hamounsbi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamoun Sabri
Position
Student, Faculty of Dentistry
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 23 Amid St, Zaferanieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985955817
Phone
+98 21 2241 1626
Email
Hamounsbi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamoun Sabri
Position
Student, Faculty of Dentistry
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 23 Amid St, Zaferanieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985955817
Phone
+98 21 2241 1626
Email
Hamounsbi@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data related to soft tissue variables of the nose will be available without mentioning the names, information and images of patients and only in the form of numerical data and related analyzes. It is worth mentioning that the biographical information of patients such as age, gender, race, etc. will be expressed without mentioning the names or pictures of the patients' faces.
When the data will become available and for how long
The data access period will start from the time the results are published.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions as well as to people working in industry.
Under which criteria data/document could be used
1. Carrying out study and research in the field related to this study
2. Conducting review studies
From where data/document is obtainable
Applicants for information and documentation can apply in the following ways:
1- Email to: Hamounsbi@gmail.com
2- Phone call with the contact number: 00989123807579
What processes are involved for a request to access data/document
Data and documentation are stored in obj and EXCEL files. Therefore, after confirming the request, these files will be provided to the applicant.