Comparison of the amount of pain, edema and maximum mouth opening before and after the broken zygomatic arch reduction by new method of using fifty mm needle without surgery cut
Comparison of the amount of pain, edema and maximum mouth opening before and after the broken zygomatic arch reduction by new method
Design
Clinical trial; not blinded without control group. Pre and post operative measurement
Settings and conduct
In this research we used a new method: using fifty millimeters needle without surgery cut for replacement of broken zygomatic arch and we compromise the amount of pain, edema, maximum mouth opening and ecchymosis before and after the surgery.
Participants/Inclusion and exclusion criteria
In this situations patients can involved in the study: unilaterally or bilaterally fractures in zygomatic arch; indication for surgery; limitation in moth opening; clinically depression in zygomatic arch
in this situations patients should exit from study: multiple fractures in zygomatic arch;other fractures in nasal bone and midfaces;no bone contact;uncontrolled systemic diseases;visiting after 3 weeks
Intervention groups
In all selected patients zygomatic arch reducted with new method of surgery and then the amount of pain, edema and maximum mouth opening before and after the surgery measure
Main outcome variables
Pain; edema and scars after surgery; more opening mouth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200620047836N1
Registration date:2020-07-07, 1399/04/17
Registration timing:registered_while_recruiting
Last update:2020-07-07, 1399/04/17
Update count:0
Registration date
2020-07-07, 1399/04/17
Registrant information
Name
Zahra Dalirakbari azar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 2864
Email address
zahradelirakbari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-27, 1399/04/07
Expected recruitment end date
2020-07-28, 1399/05/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the amount of pain, edema and maximum mouth opening before and after the broken zygomatic arch reduction by new method of using fifty mm needle without surgery cut
Public title
Comparison of the amount of pain, edema and maximum mouth opening before and after the broken zygomatic arch reduction by new method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilaterally or bilaterally fractures in zygomatic arch
Indication for surgery
Limitation in moth opening
Clinically depression in zygomatic arch
Exclusion criteria:
Multiple fractures in zygomatic arch
Other fractures in nasal bone and midfaces
No bone contact
Uncontrolled systemic diseases
Visiting after 3 weeks
Age
From 25 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
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
Rregional research ethics committee, Tabriz University of Medical Sciences
Street address
3rd Floor, Central Building, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-06-08, 1399/03/19
Ethics committee reference number
IR.TBZMED.REC.1399.235
Health conditions studied
1
Description of health condition studied
Isolation fracture in zygomatic arch
ICD-10 code
S02.402
ICD-10 code description
Zygomatic fracture
Primary outcomes
1
Description
The amount of pain before and after the surgical procedure of zygomatic arch reduction with a 50 mm needle
Timepoint
Before and immediately after surgery and 1 week later
Method of measurement
Visual Analog Scale (VAS)
2
Description
The amount of edema before and after the broken zygomatic arch reduction by new method of using fifty mm needle without surgery cut
Timepoint
Before and immediately after surgery and 1 week later
Method of measurement
The distance from the tragus to the corner of the eye and the distance from the tragus to the corner of the mouth by the ruler
3
Description
The amount of maximum mouth opening before and after the broken zygomatic arch reduction by new method of using fifty mm needle without surgery cut
Timepoint
Before and immediately after surgery and 1 week later
Method of measurement
Maximum opening without any pressure or pain and Measure the distance between the incisal edge of the upper and lower front teeth with a ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: of all the patients suspected of having a zygomatic arch fracture who referred to Imam Reza Hospital in Tabriz and wish to participate in the study, as well as with one or more symptoms, including arch-like depression, non-opening of the mouth, pain and tenderness in the arch-like area, After obtaining informed consent, spiral, axial, and coronal CT scans will be received. In the operating room, after anesthesia under Ural intubation, the location of the arch will be determined by touch and marked with a marker. Two 50 mm needles are selected. The first needle is 15 mm in front of the tragus and the second needle is 30 mm in front of the tragus. They enter from the top of the arch and exit the lower part of the arch so that the tip of the needle is at the bottom of the arch and the end of the needle is at the top .The tips and ends of the needles are then removed by four separate needles and pulled out slowly and with gentle to moderate force to determine the touch of the reaction. Then, for external fixation, zero nylon thread is inserted from inside each needle and the needle is removed from the opposite side, and then the needles are removed and the thread along with an abslange will be used as external fixation.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Medical Research & Training Hospital
Full name of responsible person
Zahra Delirakbari Azar
Street address
in front of the Central Building, Gholghasht Street,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
zahradelirakbari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samii
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street,
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 7054
Email
zahradelirakbari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?