Determining the evaluation of nasal width before and six months after rhinoplasty surgery in patients referred to Bouali and Farhikhtegan hospitals in Tehran
Design
Clinical trial, with 30 samples, with single group and without control group
Settings and conduct
Research on 30 patients referred to Bouali and Farhikhtegan Hospitals who underwent rhinoplasty surgery. Before surgery, a photograph was taken of the patient with standard conditions and Rhino analysis of the patient and the dimensions of the study, including Inter Alar Width and its ratio to lines. The medial canthus of the two sides, which is the gold standard in this ratio, is measured one by one, and the length of the upper lip is also measured before surgery. A questionnaire is also provided to patients that the patient expresses his satisfaction with the width of the nose in the Inter Alar areas from zero to ten.
Participants/Inclusion and exclusion criteria
Candidate patients for rhinoplasty surgery; age at least 18 years old; does not have any systemic diseases; do not take any medication
Intervention groups
The intervention performed in this study on the target group is rhinoplasty cosmetic surgery. Surgery is performed without alar resection and without manipulating the depressor septi nasi muscle.
Main outcome variables
The distance between the alarms; upper lip length
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210705051791N1
Registration date:2021-08-01, 1400/05/10
Registration timing:prospective
Last update:2021-08-01, 1400/05/10
Update count:0
Registration date
2021-08-01, 1400/05/10
Registrant information
Name
Amir Mousavi Yazdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2280 8828
Email address
mousavibabak68@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of nasal width before and after rhinoplasty surgery in patients referred to Bouali and Farhikhtegan hospitals in Tehran after 6 months
Public title
Evaluation of nasal width before and after rhinoplasty surgery in patients referred to Bouali and Farhikhtegan hospitals in Tehran after 6 months
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for rhinoplasty surgery
Age at least 18 years old
Does not have any systemic diseases
Do not take any medication
Exclusion criteria:
Having any kind of systemic diseases including diabetes, AIDS, osteoporosis, etc
Existence of any pathological soft or hard tissue lesions of the mouth
Patients with mental disorders
Taking any medication during the last 6 months
History of smoking, alcohol and drugs
History of radiotherapy in the maxillofacial area in the past year
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Azad university of Tehran of medical sciences
Street address
No.9, Neyestan 9 Ave., Pasdaran Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-06-13, 1399/03/24
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.054
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The width of the nose
Timepoint
Six months after rhinoplasty surgery
Method of measurement
Photography
Secondary outcomes
empty
Intervention groups
1
Description
Research on 30 patients referred to Bouali and Farhikhtegan Hospital who underwent rhinoplasty surgery. Before surgery, a photograph was taken of the patient with standard conditions and Rhino analysis of the patient and the dimensions of the study, including Inter Alar Width and its ratio to lines. The medial canthus of the two sides, which is the gold standard in this ratio, is measured one by one, and the length of the upper lip is also measured before surgery. A questionnaire is also provided to patients that the patient expresses his satisfaction with the width of the nose in the Inter Alar areas from zero to ten. Surgery is performed without alar esection and without manipulation of the depressor septi nasi muscle.After surgery and 6 months after surgery and reduction of patient swelling, another photo of the patient is prepared and re-analyzed on the patient photo and the desired dimensions are obtained and the questionnaire will be given to the patient again to express his satisfaction. Determine the width of the nose after rhinoplasty from zero to ten. The data are then analyzed by paired t test, which shows changes in alar width before and after surgery, as well as patient satisfaction before and after surgery. There is also another statistical test called the Pearson correlation test to show the relationship between satisfaction and Alar changes before and after surgery.Photography is done by a canon camera with 5D mark3 model with a macro lens 100 and at a distance of 3 meters from the subject and in the same light conditions in the studio
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali Hospital
Full name of responsible person
Amir Mousavi Yazdi
Street address
Damavand Ave., Emam Ali Highway
City
Tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3331 1107
Email
booali.hospital96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No. 9, Neystan 9, Pasdaran Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
mousavibabak68@yahoo.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
100
Public or private sector
Public
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
Amir Mousavi Yazdi
Position
oral and maxiilo facial surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Neyestan 9 Alley, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
mousavibabak68@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Mousavi Yazdi
Position
Resident of oral and maxillofacial surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Neyestan.9 Alley, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
Email
mousavibabak68@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Mousavi Yazdi
Position
Resident of oral and maxillofacial surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Neyestan 9 Alley, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
Email
mousavibabak68@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be shared
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions And cosmetic and maxillofacial surgeries
Under which criteria data/document could be used
There is no other case
From where data/document is obtainable
Research site of the Faculty of Dentistry, Azad Tehran, to www.dental.iautmu.ac.ir
What processes are involved for a request to access data/document
Theses and articles are stored on the site www.dental.iautmu.ac.ir and the client can access the data after registering on this site.