Aim of study: To evaluate the effect of cutting of depressor septi nasi muscle in tip rhinoplasty. Study design: Clinical trial Methods: Primary rhinoplasty patients who required nasal tip modifications were divided into two equal groups and patients in case group underwent rhinoplasty including cutting of depressor septi nasi muscle. The results of the operation were compared to control group 6 months after the operation. Study population: Primary rhinoplasty patients. Inclusion criteria: All primary rhinoplasty patients who also required nasal tip modification Exclusion criteria: patient do not sign consent form, Lack of necessity for cutting of depressor septi nasi muscle. Studied population: 80. Intervention: Cutting of depressor septi nasi. Study duration: 2008-2012. Primary outcomes: Changes of tip rotation and tip projection after cutting of depressor septi nasi muscle
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106086745N1
Registration date:2011-08-08, 1390/05/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-08, 1390/05/17
Registrant information
Name
Javad Seyed Toutounchi
Name of organization / entity
Tabriz University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 2076
Email address
javadtotonchis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2008-10-22, 1387/08/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial evaluation of the effect of depressor septi nasi cutting on nasal tip rotation and projection in rhinoplasty patients
Public title
The effect of depressor septi nasi cutting in nasolabial angle and nasal tip form
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All primary rhinoplasty patients who also required nasal tip modification
Exclusion criteria: patient do not sign consent form, Lack of necessity for cutting of depressor septi nasi muscle.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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 Tabriz University of Medical Sciences
Street address
Golgasht st., Daneshgah st.
City
Tabriz
Postal code
Approval date
2008-10-05, 1387/07/14
Ethics committee reference number
8732
Health conditions studied
1
Description of health condition studied
Tip rhinoplasty
ICD-10 code
Z41.1
ICD-10 code description
Other plastic surgery for unacceptable cosmetic appearance
Primary outcomes
1
Description
Tip rotation
Timepoint
Before and 6 months after rhinoplasty
Method of measurement
Measuring nasolabila angle
2
Description
Tip projection
Timepoint
Before and 6 months after rhinoplasty
Method of measurement
Good's method
3
Description
Patient satisfaction
Timepoint
6 months after rhinoplasty
Method of measurement
Using questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
cutting of depressor septi nasi muscle in nasal tip modification
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Javad Seyed Toutounchi
Street address
Golgasht st., Daneshgah st.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Javad Seyyed Toutounchi
Street address
Golgasht st., Daneshgah st.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?