Protocol summary

Summary
This study will be done as a randomized prospective trial with a six months follow-up. The Inclusion criterion is Mandibular subcondyle fracture. Patients with infection before surgery, crashed fractures, patients with indication of open reduction and patients with Immunodeficiency will be excluded from the study. In total, 34 patients over 12 years, with sub-mandibular condyle fracture will be enrolled in the study and randomly will be classified to two groups of 17 participants. Patients in group A will be treated with archbar and intermaxillary fixation using wire and group B, will be treated with archbar and elastic method. The duration of treatment is 6 weeks. Intravenous antibiotics (cephazolin injection 1000 mg/stat and dexamethasone 8mg/stat) will be administered 30 min before surgery; and after surgery patients will receive cephazoline 4 times a day, for 3 days. After that, antibiotic (Amoxicillin 250 mg, 3 times a day) Plus Chlorhexidine mouthwash will be used for a week. General anesthesia will be done using intubation or local anesthesia. Then, the archbar for maxillary and mandibular, will be closed. After displacement of mandible and obtaining the proper occlusion, in group A, intermaxillary fixation is by wire; and in group B, Instead of fixing the jaw by wire, we will use elastic. Three-dimensional panoramic radiography and CT scan will be done before the surgery and also 6 months later.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017020732448N1
Registration date: 2017-04-14, 1396/01/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-14, 1396/01/25
Registrant information
Name
Behnam Zinhaghayegh
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 7543
Email address
zinhaghayegh.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University Of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between two close reduction techniques for treatment of mandibular subcondylar fracture: elastic versus intermaxillary wire fixation
Public title
Comparison between two close reduction techniques for treatment of mandibular subcondylar fracture: elastic versus intermaxillary wire fixation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: The Inclusion criterion is Mandibular subcondyle fracture. Exclusion criteria: Patients with infection before surgery; crashed fracture; fracture in the other site of mandible; fracture in the maxilla and in the midface region; the patients with indication of open reduction and Immunodeficiency; or the patients who are not willing to be followed up and return.
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Postal code
Approval date
2015-06-23, 1394/04/02
Ethics committee reference number
IR.AJUMS.REC.1394.712

Health conditions studied

1

Description of health condition studied
Mandibular subcondyle fracture
ICD-10 code
S02.8
ICD-10 code description
Fractures of other skull and facial bones

Primary outcomes

1

Description
Mandibular subcondyle fracture
Timepoint
3 months and 6 months after intervention
Method of measurement
categorical

Secondary outcomes

1

Description
Vertical height of Ramos
Timepoint
3 and 6 months after the intervention
Method of measurement
Panoramic CT scan

2

Description
Deviation of the jaw,when opening the mouth
Timepoint
3 and 6 months after the intervention
Method of measurement
Ruler in millimeters

3

Description
Infection
Timepoint
3 and 6 months after the intervention
Method of measurement
Observation

4

Description
Facial symmetry
Timepoint
3 and 6 months after the intervention
Method of measurement
Ruler in millimeters

5

Description
Amount of mouth opening
Timepoint
3 and 6 months after the intervention
Method of measurement
Ruler in millimeters

6

Description
Visual Analogue Scale
Timepoint
3 and 6 months after the intervention
Method of measurement
pain

Intervention groups

1

Description
control group: Patients in the control group will be treated with archbar and intermaxillary fixation using wire . Intravenous antibiotics (cephazolin injection 1000 mg/stat and dexamethasone 8mg/stat) will be administered 30 min before surgery and after surgery patients will be received cephazoline 4 times a day, for 3 days. After that, antibiotic (Amoxicillin 250 mg, 3 times a day) Plus Chlorhexidine mouthwash will be used for a week.General anesthesia will be done using intubation or local anesthesia then, the arch bar for maxillary and mandibular will be closed.
Category
Treatment - Other

2

Description
Intervention group: Patients in the Intervention group, will be treated with archbar and elastic method. Intravenous antibiotics (cephazolin injection 1000 mg/stat and dexamethasone 8mg/stat) will be administered 30 min before surgery and after surgery, patients will be received cephazoline 4 times a day, for 3 days. After that, antibiotic (Amoxicillin 250 mg, 3 times a day) Plus Chlorhexidine mouthwash will be used for a week.General anesthesia will be done using intubation or local anesthesia then, the arch bar for maxillary and mandibular arch bar will be closed.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr.Behnam Zinhaghayegh
Street address
Imam Khomeini Hospital, Sharifzadeh st. Azadegan Ave.
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Dr. Makhmal Zadeh
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
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, Ahvaz, Iran
Full name of responsible person
Pardis V akili
Position
Nutritionist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Postal code
Phone
+98 61 3337 5717
Fax
Email
vakilipardis@yahoo.comvakili.p@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Behnam Zinhaghayegh
Position
Dentist. Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Postal code
Phone
+98 61 3337 5717
Fax
Email
Dr.zinhaghayegh@gmail.comzinhaghayegh.b@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Behnam Zinhaghayegh
Position
Nutritionist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University Of Medical Sciences, Golestan Ave.
City
Ahvaz
Postal code
Phone
+98 61 3337 5717
Fax
Email
vakilipardis@yahoo.comvakili.p@ajums.ac.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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