The assessment of the effect of lateral crural steel technique on the nasolabial angle and nasal tip projection in Buali hospital and private clinic
Design
A non-randomized clinical trial study on 20 patients referred to Buali Hospital and private clinic with inclusion criteria.
Settings and conduct
This study will be a pre-and post-comparative clinical trial. Anyone who has had indication for rhinoplasty surgery and Refer to Buali hospital and the private clinic with no previous rhinoplasty surgery, No trauma to the nose, no need for jaw correction surgery, and congenital syndromic abnormalities Craniomaxilo facial, also declare their agreement after justification, will be reviewed.
At first a standard photograph is taken of the patients' profiles and measured nasolabial angle and nasal tip projection using the golden software ratio.
Then, six months later, these two variables are measured in the manner described above and compared.
Participants/Inclusion and exclusion criteria
1) The nasolabial angle of the nose should not be within the normal range of 90-110
2) Projection of the nasal tip is not within the normal range of 55-60%.
3) No evidence of previous rhinoplasty surgery.
4) No trauma to the nose and no history of trauma.
5)The patient does not require jaw surgery.
6) The patient does not have congenital craniomaxilofacial syndrome.
Intervention groups
Rhinoplasty surgery is performed on patients who meet the inclusion criteria, and the technique used in these patients to correct rotation and projection will be the only lateral crural steal technique.
Main outcome variables
nasolabial angle , nasal tip projection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046020N1
Registration date:2020-02-02, 1398/11/13
Registration timing:retrospective
Last update:2020-02-02, 1398/11/13
Update count:0
Registration date
2020-02-02, 1398/11/13
Registrant information
Name
Hamidreza Tavakoly
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2670 6733
Email address
hatv1367@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-20, 1397/03/30
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-07-01, 1397/04/10
Actual recruitment end date
2018-12-31, 1397/10/10
Trial completion date
2019-07-01, 1398/04/10
Scientific title
The assessment of the effect of lateral crural steel technique on the nasolabial angle and nasal tip projection
Public title
The assessment of the effect of lateral crural steel technique on the nasolabial angle and nasal tip projection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with indications for rhinoplasty surgery
Exclusion criteria:
normal nasolabial (90-110 degree) angle
normal nasal tip projection (55-60%)
history of rhinoplasty
need to maxillofacial corrective surgery
people with history of nasal trauma
congenital anomalies such as Craniomaxillofacial Syndrome
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
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 Islamic Azad University Central Organization
Street address
Sattari Highway, University Sq, Shohadaye Hesarak Blvd, Azad University Central Organization
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2018-05-27, 1397/03/06
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.021
Health conditions studied
1
Description of health condition studied
nasal tip rotation and projection problem
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
nasolabial angle
Timepoint
pre-op and six month post-op
Method of measurement
standard photography from facial profile by golden software ratio
2
Description
nasal tip projection
Timepoint
pre-op and six month post-op
Method of measurement
standard photography from facial profile by golden software ratio
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:rhinoplasty in persons without past rhinoplasty surgery, history of nasal trauma, need to maxillofacial corrective surgery, craniomaxillofacial syndrome, chronic disease by means of only lateral crural steal technique on nasal tip.
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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
Abstract of study, Result, General Protocole
When the data will become available and for how long
1/7/1399
To whom data/document is available
Oral and Maxillofacial Surgery Residents and professors
Under which criteria data/document could be used
Use of the research is permitted only by reference to the source
From where data/document is obtainable
hatv1367@gmail.com
What processes are involved for a request to access data/document
Send a formal request to the email referring to which part of the investigation requires complete information including the full name of the applicant including his / her name, medical education number, job and position along with sending a scan of documents including birth certificate or passport, medical system card , Residency or faculty Sentence.