This study is a prospective and randomized double-blind clinical trial. The aim of this study is to compare of the three treatment methods, single miniplate, double miniplates and 3D miniplate for open reduction of mandibular angle fracture. Total of sample size is 45 patients. The patients with infection before surgery, comminuted fracture and with immune deficiency will be excluded. The patients are randomly divided into three groups. The patients do not know about the protocol of the study and type of categories and evaluation of patients is performed by person who does not know about the protocol of the study. All the patients are under general anesthesia. First group is undergoing osteosynthesis by using single 2 mm miniplate with common champy technique. Second group isundergoing osteosynthesis by using two 2 mm miniplate. Third group is undergoing osteosynthesis by using single 3D miniplate. The amount of hemoglobin and hematocrit levels in patients is recorded before and after surgery in both groups by sampling blood. The amount of blood loss is calculated with subtracting preoperative and postoperative hemoglobin and hematocrit levels in blood. Patients do not use any medications before surgery. The temperature and the amount of body fluids can be controlled precisely by the anesthesiologist. Panoramic X-ray and facial CT scan will be recorded before and after surgery and six months after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052834186N1
Registration date:2017-06-15, 1396/03/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-15, 1396/03/25
Registrant information
Name
Shahryar Shabaninia
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2922
Email address
shabaninia.sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-03-06, 1394/12/16
Expected recruitment end date
2017-03-06, 1395/12/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the three treatment methods, single miniplate, double miniplates and 3D miniplate for open reduction of mandibular angle fracture
Public title
Comparison of three methods of treatment by using plate in the treatment of mandibular fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with unilateral or bilateral fracture of the mandible angle. Exclusion Criteria: infection before surgery; Patients with immunodeficiency; Patients with comminuted fracture; Dissatisfaction.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Ahvaz Jundishapur University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2016-03-05, 1394/12/15
Ethics committee reference number
IR.AJUMS.REC.1394.711
Health conditions studied
1
Description of health condition studied
Fracture of mandible
ICD-10 code
S02.6
ICD-10 code description
Fracture of mandible
Primary outcomes
1
Description
Bone healing and bone density analysis
Timepoint
Before and after the surgery and six months after surgery
Method of measurement
Panoramic radiography
2
Description
Pairing fracture fragments
Timepoint
Before and after the surgery and six months after surgery
Method of measurement
Facial CT scan
Secondary outcomes
1
Description
Palpability of the implants
Timepoint
Six months after surgery
Method of measurement
Questions from patient and touch the face
2
Description
Infection
Timepoint
Six months after surgery
Method of measurement
Observation and blood tests
Intervention groups
1
Description
Group I (control group): Osteosynthesis surgical of patients by using the single 2 mm miniplate with common champy technique.
Category
Treatment - Surgery
2
Description
Osteosynthesis surgical of patients by using the two 2 mm miniplate.
Category
Treatment - Surgery
3
Description
Group III (intervention group): Osteosynthesis surgical of patients by using the single 3D miniplate.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Shahryar Shabaninia
Street address
Khomeini Hospital, ShahidAhwazian St., Ahwaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shahryar Shabaninia
Position
Resident of oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
Shabaniniashahryar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Kazem Khiabani
Position
Oral and Maxillofacial Surgeon
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
Khiabani_ak@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sanaz Nazari
Position
Nurse of Anesthesia
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)