Comparison of two cinch suturing techniques (classic & reinsertion) in preventing interalar widening before and six months after maxilla orthognathic surgery (advancement, impaction, advancement and simultaneous impaction)
Comparison of two techniques (classic & reinsertion cinch suturing) in preventing interalar widening before and six months after maxilla orthognathic surgery (advancement, impaction, advancement and simultaneous impaction) in patients referred to Bo Ali Hospital
Design
Patients undergo maxillofacial LeFort 1 orthognathic surgery by Bu Ali Hospital's maxillofacial surgery team
Patients are divided into three groups based on the type of Lefort surgery: advancement, impaction, advancement, and simultaneous impaction (17). Then, six months after the surgery, patients are asked to go to Bouali Hospital and the interalar width is measured again by a specialist assistant as a blind.
Settings and conduct
Comparison of two techniques (classic & reinsertion cinch suturing) in preventing interalar widening before and six months after maxilla orthognathic surgery (advancement, impaction, advancement and simultaneous impaction) in patients referred to Bo Ali Hospital
Participants/Inclusion and exclusion criteria
Patients older than 16 years who have completed written consent
. Undergo orthognathic surgery including LeFort 1 maxillary osteotomy.
. Patients with advancements less than 5 mm and impactions less than 4 mm.
Intervention groups
Patients are divided into two groups of 15. In the first group, who underwent Lefort surgery, will be placed with the reinsertion cinch suturing technique, and the second group will be placed with the cinch suturing classic technique.
Main outcome variables
interalar width
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211029052908N1
Registration date:2021-11-26, 1400/09/05
Registration timing:prospective
Last update:2021-11-26, 1400/09/05
Update count:0
Registration date
2021-11-26, 1400/09/05
Registrant information
Name
Seyedhossein Mirpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2621 5676
Email address
dr.shmirpoor @gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-30, 1400/09/09
Expected recruitment end date
2022-05-29, 1401/03/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two cinch suturing techniques (classic & reinsertion) in preventing interalar widening before and six months after maxilla orthognathic surgery (advancement, impaction, advancement and simultaneous impaction)
Public title
Comparison of two suturing methods to collect nasal base after maxillofacial orthognathic surgery(Maxillofacial correction surgery)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 16 years who have completed written consent
Undergo orthognathic surgery including LeFort 1 maxillary osteotomy
Patients with advancements less than 5 mm and impactions less than 4 mm.
Exclusion criteria:
Patients with cleft lip or palate or another congenital disorder.
Patients with a history of maxillary surgery that may affect soft tissue due to scar tissue
Patients with advancements greater than 5 mm and impactions greater than 4 mm
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not 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 Tehran Azad University of Medical Sciences
Street address
Neystan 9, Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-12-14, 1399/09/24
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.241
Health conditions studied
1
Description of health condition studied
Skeletal Deformity of Jaws
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Interalar width: The width of the base of the nose is the distance between the most prominent point on both sides of the blade of the nose, the ideal position of which should be 1 mm more than the distance between the two inner cantons of the eyes.
Timepoint
Six months after surgery
Method of measurement
Patients are divided into three groups based on the type of Lefort surgery: advancement, impaction, advancement, and simultaneous impaction (17). Then, six months after the surgery, patients are asked to go to Bouali Hospital and the interalar width is re-measured blindly by a specialist assistant. Third party assistant (except surgical team and project manager) is used after intra-surgical operation.
Secondary outcomes
empty
Intervention groups
1
Description
alar cinch suture will be used by classic method and reinsertion cinch. For this purpose, a 33 mm needle with 2-0 Nylon monofilament thread of LINX brand made in India is used. In the classic method: the mucosa and muscle on one side are taken with nylon thread 2_0, then the mucosa and muscle on the opposite side are taken directly without touching the skin of the muscle and mucosa on both sides and pulled together.
Category
Treatment - Surgery
2
Description
Intervention group: alar cinch suture will be used by classic method and reinsertion cinch. For this purpose, a 33 mm needle with 2-0 Nylon monofilament thread of LINX brand made in India is used. In the reinsertion method: mucosa and The muscle on one side of the baselar is taken from inside the mouth and the needle comes out of the skin of the baselar area on one side and enters from the same area, and then the mucus, muscle and skin of the other side are taken in this way and finally The two sides of the base are pulled together and swing in the midline.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali Hospital
Full name of responsible person
Hosein Mirpour
Street address
Damavand Street,Emam Ali Highway,Tehran
City
Tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3331 1106
Email
booali.hospital96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hosein Taffazoli Shadpour
Street address
Neyestan 9,Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Dr.shmirpoor @gmail.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
Seyedhossein Mirpoor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Neyestan 9,Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2621 5676
Fax
Email
Dr.shmirpoor @gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedhossein Mirpoor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Neyestan 9,Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2621 5676
Fax
Email
Dr.shmirpoor @gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedhossein Mirpoor
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Neyestan 9,Pasdaran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2621 5676
Fax
Email
Dr.shmirpoor @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
Comparison of two techniques (classic & reinsertion cinch suturing) in preventing interalar widening before and six months after maxilla orthognathic surgery (advancement, impaction, advancement and simultaneous impaction) in patients referred to Bo Ali Hospital
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
Under which criteria data/document could be used
There is no other special case
From where data/document is obtainable
To the faculty research site at www.ris.iau.ac.ir
What processes are involved for a request to access data/document