To evaluate the effect of depressor septi muscle resection on projection and rotation of the nose in rhinoplasty patients with who have nasal drooping with laughter and comparison with control group: by tongue in groove technique; single blind randomized controlled trial
Determining the effect of depressor septi nasi resection on nasal projection and rotation in rhinoplasty patients who have drooping tip when smiling and compare it to the control group undergone tongue-in-groove technique
Design
A randomized trial with a control group, with parallel groups, single blind, randomized, on 37 patients in each group - Excel software rand function was used for randomization.
Settings and conduct
Patients who have referred to the Facial Plastic Surgery Clinic of Imam Khomeini Hospital and experience nasal drooping while laughing will be randomly divided into two groups. In the intervention group, the depressor septi muscle will be incised, but in the control group, it will remain intact. This study is single blind in that the evaluator of the research result and analyzer will be blinded.
Participants/Inclusion and exclusion criteria
All patients referred to the clinic enter the study during this period when they have referred to the clinic and are willing to participate in the study.
Intervention groups
In the control group: tongue in groove placed on the caudal septum or cartilage extension.
In the intervention group: In addition to the intervention mentioned in the control group, the septum of the septum depressor muscle will be cut by sub-labial incision.
Main outcome variables
Projection rate; Rotation rate; Upper lip height; Upper lip position; Satisfaction with the result of the surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080820001056N6
Registration date:2021-08-16, 1400/05/25
Registration timing:prospective
Last update:2021-08-16, 1400/05/25
Update count:0
Registration date
2021-08-16, 1400/05/25
Registrant information
Name
babak saedi
Name of organization / entity
tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 2270 0765
Email address
saedi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effect of depressor septi muscle resection on projection and rotation of the nose in rhinoplasty patients with who have nasal drooping with laughter and comparison with control group: by tongue in groove technique; single blind randomized controlled trial
Public title
To assess the effect of depressor septi nasi resection on nasal projection in patients who have drooping tip when smiling
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients referred to the ENT clinic of Imam Khomeini Hospital
Exclusion criteria:
Previous rhinoplasty surgery
Congenital disease of the nose and lips
Dental or jaw problem
History of systemic disease
History of maxillary trauma
Surgery limited to the bony part of the nose
Injection of filler in the lips and nose
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with Block randomization method are grouped into quadruple blocks, designed by a statistical methodologist. The random assignment list is at the disposal of the supervisor and based on that, patients who have been given surgery and are satisfied with the surgery are divided into groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the need to make an additional incision under the lip in the intervention group, it is not possible to blind patients. The analysis of the photos and the relevant questionnaire is done by the ENT resident or the Facial Plastic Surgery Fellowship who does not know the type of intervention. Data collectors and those evaluating the outcome, as well as the Data Safety and Monitoring Committee and those drafting the article, are also blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-07-18, 1400/04/27
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.155
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The degree of drooping of the nose when laughing
Timepoint
One year after the surgery
Method of measurement
Rate of nasal projection and rate on nasal rotation
Secondary outcomes
1
Description
Degree of patients’ satisfaction
Timepoint
One year after surgery
Method of measurement
Visual Anologue Scale و SCHNOS(Standardized Cosmesis and Health Nasal Outcome Survey)
Intervention groups
1
Description
Intervention group: tongue in groove placed on the caudal septum, and then the septum of the septum depressor muscle will be cut by sub-labial incision. Control group: tongue in groove technique on the caudal septum.
Category
Treatment - Surgery
2
Description
Control group: tongue in groove technique on the caudal septum.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr. Babak Saedi
Street address
Qarib St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 6405 3334
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Shayad Dasdar
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Qarib St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Shayandasdar1374@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Babak Saedi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Qarib St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Saedi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nika Kianfar
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Qarib St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Shayandasdar1374@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
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 is potentially shareable after unidentified individuals
When the data will become available and for how long
Six months after publication
To whom data/document is available
Researchers
Under which criteria data/document could be used
Only for researching purposes
From where data/document is obtainable
Shayan Dasdar
Email: shayandasdar1374@gmail.com
What processes are involved for a request to access data/document
A written request from a valid place is required. Then, within 2 weeks the data will be provided.