Assessment of the Effect of the Tongue in Groove Technique in Nasolabial Angle and Nasal Tip Projection Changes
Design
Clinical trial with before and after comparison
Settings and conduct
Patients which refer to oral and Maxillofacial department of Buali hospital and private office.
The study is a randomized clinical trial before and after assessments and follow up for 6 months.
Participants/Inclusion and exclusion criteria
Exclusion criteria consist of the history of previous septo rhinoplastic surgery; trauma to the nose; normal range of nasolabial angle (90-110) and normal tip projection according to good method assessment (55-60 %). Also any jaws deformity requiring orthognathic surgery and any craniomaxillofacial syndrome causing nose deformation, was excluded. Inclusion criteria consist of an abnormal range of naso labial angle and nasal tip projection which should be out of the normal range of 90-110 degree and 55-60%,a patient with a clear history of cranio facial syndrome; trauma to the nose,rhinoplastic surgery; jaw deformities and also a surgery done just based on TIG technique without any other methods contribution which affecting on tip and radix area.
Intervention groups
Tongue in groove surgical technique by definition involves a method by which the medial crura is pulled posteriorly over the caudal part of the nasal septum, in fact this is a type of intervention on the treated specimens. Some angles, such as nasolabial angle or nasal projection, are within the normal range,by using this method. This technique also has effects such as correction of septal deviation or colomellar overexpression, which were not examined in this study. Non-use of cartilage, this technique is more and more popular today.
Main outcome variables
Nasolabial Angle; Nasal Tip Projection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180102038189N1
Registration date:2019-12-31, 1398/10/10
Registration timing:retrospective
Last update:2019-12-31, 1398/10/10
Update count:0
Registration date
2019-12-31, 1398/10/10
Registrant information
Name
Fatemeh Khabir
Name of organization / entity
Dental branch of azad university
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4570
Email address
khabirf@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-31, 1396/11/11
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2018-03-01, 1396/12/10
Actual recruitment end date
2019-05-23, 1398/03/02
Trial completion date
2019-11-07, 1398/08/16
Scientific title
Assessment of the Effect of the Tongue in Groove Technique in Nasolabial Angle and Nasal Tip Projection Changes
Public title
The Effect of the Tongue in Groove Technique in Nasal Tip Changes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The limit of the Nasolabial Angle should not be in normal range of 90-110 degree
The limit of the Nasal Tip Projection should not be in normal range of 55-60 percentages
The patient should not have a past rhinoplasty surgery
The patient should not have a Craniomaxillofacial syndrome
The patient should not have a Maxillofacial skeletal deformity
The patient should not have a history of trauma to the nose
The surgery should be done based on TIG technique and other methods effecting on nasal tip and nasal radix should not be done
Exclusion criteria:
The limit of the Nasolabial Angle is in the normal range of 90-110 degree
The limit of the Nasal Tip Projection is in the normal range of 55-60 percentages
The patient had a past rhinoplasty surgery
The patient has a Craniomaxillofacial syndrome
The patient has a Maxillofacial skeletal deformity
The patient has a history of trauma to the nose
The surgery should be done in associated with other methods effecting on nasal tip and nasal radix
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Not randomized
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
Islamic Azad University, Dental branch
Street address
Pasdaran Ave., 9th Neiestan
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2018-05-27, 1397/03/06
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.022
Health conditions studied
1
Description of health condition studied
Changes in Nasolabial Angle and Nasal Tip Projection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The measure of Nasolabial Angle
Timepoint
Pre operative measuring,immediate post operative measuring,6 months after the surgery
Method of measurement
Measuring by Using Standard Photography with Golden Ratio Software
2
Description
The Measure of Nasal Tip Projection
Timepoint
Pre operative measuring,immediate post operative measuring,6 months after the surgery
Method of measurement
Measuring by Using Standard Photography with Goode technique
Secondary outcomes
empty
Intervention groups
1
Description
Tongue in groove surgical technique by definition involves a method by which the medial crura is pulled posteriorly over the caudal part of the nasal septum, in fact this is a type of intervention on the treated specimens. Some angles, such as nasolabial angle or nasal projection, are within the normal range,by using this method. This technique also has effects such as correction of septal deviation or colomellar overexpression, which were not examined in this study. Non-use of cartilage, this technique is more and more popular todayThe study is a comparative study ;before and after using the technique. The groups undergoing surgical intervention using the above technique will be measured after angular and projection correction . It is technically sensitive and has very stable results, technically most surgeons refuse to do it and prefer simple techniques with poor results, but in aesthetic practice long-term survival is the principle.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Buali Hospital, Oral and Maxillofacial Surgery Branch
Full name of responsible person
Mehdi Sezavar
Street address
Damavand Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 3331 1107
Email
Khabirf@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
9th Neiestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4570
Email
Khabirf@ymail.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
Fatemeh Khabir
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Pasdaran Ave,.9th Neiestan Alley
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4570
Email
Khabirf@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Khabir
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Pasdaran Ave.,9th Neiestan Alley
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4570
Email
Khabirf@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Khabir
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Pasdaran Ave.9th Neiestan alley
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 3331 1107
Email
Khabirf @ymail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available