Comparison of accuracy between standard surgical splint and modified interpretative adjustable splint in transferring of anteroposterior position of maxilla during Le Fort I osteotomy
Comparison of the efficiency of the adjustable surgical wafer compared to the standard intermediate wafer, in the transfer of the anterior-posterior position of maxilla during Lefort I osteotomy
Design
Horizontal osteotomy line on the bone first will be marked with a cutter, on the area of the canine and molar teeth two vertical lines are drawn on it.Then osteotomy performed and the maxilla will be broken down. The standard wafer is placed first and the upper jaw is moved upwards with hand pressure so that the two pieces are reattached in the osteotomy line and the vertical line displacement on the moving piece (Down fractured maxilla) is shifted. The vertical line is measured on the fixed piece. If this shift is to the front, it is displayed with positive numbers, and if it is backwards, it is displayed with negative numbers. Now the adjustable wafer is set and the displacement of the lower vertical line is measured relative to the upper. This process will be repeated with wafers made in positions 1-a, 2-a, 3-a, as well as 1-p, 2-p, and 3-p.
Settings and conduct
Clinical trials at Besat Hospital in Hamadan in 2020 will be performed on patients who require lefort1 osteotomy surgery in because of maxillary symmetry.
Participants/Inclusion and exclusion criteria
Patients with problems in the sagittal dimension of maxillary classified as class 2 and 3 according to the classification of the maxillary- skeletal relationship.
criteria for not entering the study: Patients with a history of previous orthognathic surgery, teeth-less patients and patients need vertical changes
Intervention groups
Intervention group: Adjustable surgical wafers will be used to determine maxillary position during Lefort 1 surgery.
Control group: Standard surgical wafers will be used to determine maxillary position during Lefort 1 surgery.
Main outcome variables
Changes in the maxillary reference lines
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N7
Registration date:2020-06-13, 1399/03/24
Registration timing:registered_while_recruiting
Last update:2020-06-13, 1399/03/24
Update count:0
Registration date
2020-06-13, 1399/03/24
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-19, 1398/12/29
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of accuracy between standard surgical splint and modified interpretative adjustable splint in transferring of anteroposterior position of maxilla during Le Fort I osteotomy
Public title
Le Fort I osteotomy for transferring of anteroposterior position of maxilla
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Problem in sagittal dimension of Jaw
Class 2 & 3 Jaw skeletal connection
Need to change just in sagittal dimension
Exclusion criteria:
Patients with previous history of orthognathic surgery
Toothless patients
Patients need vertical changes
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
We made 20 cards and write letter A on 10 for adjustable splint and on the other 10 letter S for the standard surgical splint group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the letters will be randomly selected and opened, based on selected letter ( A or S) patients will be assigned to adjustable surgical splint or standard surgical splint group.
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 Hamadan University of Medical Science
Street address
Shahid Fahmideh Avenue
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
IR.UMSHA.REC.1399.214
Health conditions studied
1
Description of health condition studied
Asymmetry of maxillary and mandibular
ICD-10 code
M26.11
ICD-10 code description
Maxillary asymmetry
Primary outcomes
1
Description
Maxillary movement
Timepoint
before and after Surgery
Method of measurement
The measurement is made with a ruler
Secondary outcomes
1
Description
Maxilla displacement in sagittal dimension
Timepoint
before and after surgery
Method of measurement
The measurement is made with a ruler
Intervention groups
1
Description
Intervention group: In each patient, first the upper and lower jaw casts will be prepared and transferred to the articulator using Face bow. Then, based on the data obtained from the clinical analysis, photography and lateral cephalometry, the position of the upper and lower jaw is determined. Then, the patient's sergeant model is started and the upper jaw cast will be fixed at the designated position (position 0). For this purpose, first a standard (thin) wafer is made and then this wafer is removed and another wafer will be made using the made device (adjustable wafer). The upper jaw will be detached from the articulator base and fixed one millimeter stronger to the base (position 1-a) and a standard wafer and a thick adjustable wafer will be made for it. This process is in the position of two millimeters more anterior (position 2-a) and 3 mm more anterior (position 3-a), one millimeter more posterior (position 1-p), two millimeters more posterior (position 2-p) and three A more posterior millimeter (3-p position) will be repeated. In each case, a standard wafer and an adjustable wafer are made. During surgery, a horizontal osteotomy line is first marked on the bone with a milling cutter, and two vertical lines are drawn on the canine and molar teeth in the first area. An osteotomy is performed and the maxilla is broken down. At this time, the standard wafer will be placed first and the upper jaw will be moved upwards with the pressure of the hand so that the two pieces in the osteotomy line come together again and the amount of vertical line movement on the moving piece (Down fractured maxilla) The vertical line will be measured on the fixed piece. If this shift is to the front, it will be displayed with positive numbers, and if it is backwards, it will be displayed with negative numbers. Now the adjustable wafer is set and the displacement of the lower vertical line is measured relative to the upper. This process will be repeated with wafers made in positions 1-a, 2-a, 3-a, as well as 1-p, 2-p, and 3-p. If any error occurs, this error is the same on both devices. will be. Therefore, it will not affect the comparison of the two devices. In addition, all necessary measures are taken to control these rotations during operation.
Category
Treatment - Devices
2
Description
Control group: The surgical procedure in this group is similar to the intervention group, except that a standard splint will be used instead of an adjustable splint to determine the maxillary position during the Lefort I osteotomy surgery.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
dr Mohammad Reza Jamalpour
Street address
Shahid Beheshti Blvd
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
Besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr Saeid Bashirian
Street address
Shahid Fahmide Ave
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamedan shahid fahmideh street medicine school
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Jamalpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Blv
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Email
Jamalpour_omfs@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Nonacademic staff of community Medicine
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
shahid fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir
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
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared except for authors names
When the data will become available and for how long
From 2021 onward it is permissible
To whom data/document is available
Researchers in all fields
Under which criteria data/document could be used
To develop research and science
From where data/document is obtainable
Correspond to the email address of the scientific responsible for the study
What processes are involved for a request to access data/document