Evaluation of changes in external airway resistance and basal alar size following Lefort 1 osteotomy with anatomical shaping of the nasal preform area in orthognathic surgery patients
The effect of allar base shaping on preventing unwanted consequences after surgery, such as increasing the width of the nose
Investigating the effect of allar base shaping on improving respiratory status
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, including 30 patients in two groups of 15 people. Random allocation software was used for randomization.
Settings and conduct
study in patients with jaw problems will be performed to reduce the complications of this surgery in Al-Zahra and Ayatollah Kashani hospitals .All orthognathic surgeries will be performed by a surgeon with the same surgical team.
They will be blind researchers and evaluators.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients undergoing orthodontic treatment are candidates for maxillofacial surgery (regardless of age and sex)
The amount of movement of the upper jaw should not be more than 3 mm.
Exclusion criteria:
History of trauma and fracture in the middle of the face
Patients with a history of congenital facial abnormalities (such as cleft palate)
Intervention groups
A typical Le Fort I osteotomy is performed in both groups.
In order to prevent the flattening of the nasal alars (due to the fact that in the new maxilla the space for the fins has been reduced) in the control group for patients to control the position of the alarms from cinch suture Commonly used.
In the intervention group, to control the position of the nasal passages, cutting and shaping the bone of the nasal cavity and preform is used to increase the space available for the nose. Cutting the bone of the nasal floor and the bone around the nose with a milling process will be 2 mm
Main outcome variables
The new method may improve the shape of the jawbone and ultimately improve postoperative breathing and reduce nasal congestion. It may also be effective in reducing nasal flattening.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200704047996N2
Registration date:2022-02-10, 1400/11/21
Registration timing:registered_while_recruiting
Last update:2022-02-10, 1400/11/21
Update count:0
Registration date
2022-02-10, 1400/11/21
Registrant information
Name
ali kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4264 8448
Email address
alikazemi_dnt@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-28, 1400/11/08
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
Evaluation of changes in external airway resistance and basal alar size following Lefort 1 osteotomy with anatomical shaping of the nasal preform area in orthognathic surgery patients
Public title
Evaluation of the effect of anatomical shaping of the nasal preform area in orthognathic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing orthodontic treatment and are candidates for maxillofacial surgery
The amount of movement of the maxilla is less than 3 mm
Exclusion criteria:
History of trauma and fracture in the middle of the face
Patients with a history of congenital facial abnormalities (such as cleft palate)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind, the study of measurements is done by one person and then anonymous information will be provided to another person for examination.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar jerib St
City
Isfahan
Province
Isfehan
Postal code
8975126354
Approval date
2022-01-16, 1400/10/26
Ethics committee reference number
IR.NUI.RESEARCH.REC.1400.416
Health conditions studied
1
Description of health condition studied
Complications of orthognathic surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Width of nasal alar base
Timepoint
3 months before surgery and 3 months after surgery
Method of measurement
Soft tissue calipers
2
Description
Respiratory function
Timepoint
3 months before surgery and 3 months after surgery
Method of measurement
rhinometry test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A typical Le Fort I osteotomy is performed to separate the maxilla and correct its position. In the intervention group, to control the position of the nasal alar base, cutting and shaping the bone of the nasal cavity and preform is used to increase the space available for the nose. Cutting the bone of the nasal floor and the bone around the nose with a milling process will be 2 mm diameter
Category
Prevention
2
Description
Control group: A typical Le Fort I osteotomy is performed to separate the maxilla and correct its position. In the control group, the usual cinch suture is used to control the position of the alarms
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Surgery, Isfahan School of Dentistry
Full name of responsible person
Ali kazemi
Street address
Department of Surgery, Isfahan Dental School ,Shohada-e-Sefeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8745129546
Phone
+98 913 717 9459
Email
alikazemi_dnt@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Siavash dasjerdi
Street address
Deputy of research and technology, Building No. 4, Isfahan University of Medical Sciences and Health Services,Hezar Jerib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali kazemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 4264 8448
Email
alikazemi_dnt@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali kazemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 4264 8448
Email
alikazemi_dnt@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali kazemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 4264 8448
Email
alikazemi_dnt@yahoo.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
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available