The aim of this study was to assess the effects of pulsed electromagnetic field on healing time after mandibular bone fracture reduction. Totally, 20 patients were recruited according to inclusion and exclusion criteria from patients attending operating room of Imam Khomeini Hospital with mandibular fracture. The random sampling was used. Patients were randomly assigned into intervention group to receive the pulsed electromagnetic field therapy and control group with ratio of 1:1. The patients in intervention group, firstly underwent local anesthesia, then the arch bars of maxilla and mandible are closed, mandible bone fracture was reduced using closed reduction, after establishing primary occlusion the strong elastics (3/16 inch- 6/5 oz) were applied and then IMF (intermaxillary fixation) was performed in an appropriate occlusion. Pulsed electromagnetic field was administered for 10 min/day for 10 days after reduction. The same procedures were performed for control group, except they did not received pulsed electromagnetic therapy after reduction. The effectiveness assessment of pulsed electromagnetic field therapy was performed by the bone density measurement using Hounsfield of the CT (computed tomography) scans of head and face at 10th and 40th day after the reduction for both intervention and control groups. All study patients were checked for tooth abscess and tooth infection. In addition, patients were followed-up 8 weeks after IMF extraction to evaluate tooth occlusion after surgery, MAO (maximum anterior opening), pain, bone union and infection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062428608N1
Registration date:2016-07-17, 1395/04/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-17, 1395/04/27
Registrant information
Name
Ershad Hemmati
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 6104
Email address
hemmati.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-08-21, 1394/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of pulsated electromagnetic waves on the healing time of mandibular bone fracture
Public title
Effect of electromagnetic on reducing healing time in jaw fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: minimum age of 14 for women and 16 for men; Non-displaced and mandibular with closed reduction possibility; malocclusion of teeth due to fracture; and resident of Ahvaz. Exclusion criteria: maxillary and mid-face bones fractures; Fractures with indication of ORIF (Open reduction inter maxillary fixation); Infected teeth in the site of fracture; epilepsy; seizure; and pregnancy.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences Ahvaz,Golestan Boulevard, Ahvaz
City
Ahvaz
Postal code
Approval date
2016-02-13, 1394/11/24
Ethics committee reference number
IR.AJUMS.REC.1395.189
Health conditions studied
1
Description of health condition studied
Mandibular bone fracture
ICD-10 code
S02.6
ICD-10 code description
Fracture of mandible
Primary outcomes
1
Description
Healing time
Timepoint
At 10 and 40 days after surgery
Method of measurement
Bone density by CT scans of head and face
Secondary outcomes
1
Description
Pain
Timepoint
at 10 and 40 days after closed reduction
Method of measurement
Visual analogue scale (VAS)
Intervention groups
1
Description
Intervention group: The patients in intervention group, firstly underwent local anesthesia, then the arch bars of maxilla and mandible are closed, mandible bone fracture was reduced using closed reduction, after establishing primary occlusion the strong elastics (3/16 inch- 6/5 oz) were applied and then IMF (intermaxillary fixation) was performed in an appropriate occlusion. Pulsed electromagnetic field was administered for 10 min/day for 10 days after reduction.
Category
Treatment - Devices
2
Description
Control group: The patients in control group, firstly underwent local anesthesia, then the arch bars of maxilla and mandible are closed, mandible bone fracture was reduced using closed reduction, after establishing primary occlusion the strong elastics (3/16 inch- 6/5 oz) were applied and then IMF (intermaxillary fixation) was performed in an appropriate occlusion. No pulsed electromagnetic field was administered for the control group after reduction.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Maxillofacial Operating Room of Imam Khomeini Hospital
Full name of responsible person
Ershad Hemmati
Street address
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
Behzad Sharif Makhmalzadeh
Street address
Golestan Boulevared
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
Zeinab Shajirat
Position
Master of Sciences
Other areas of specialty/work
Street address
Fourth floor, Imam Khomeini Hospital, Azadegan Boulevard, Research Deputy of Imam Khomeini Hospital Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3221 6504
Fax
Email
zeinab.shajirat@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
Ershad Hemmati
Position
Resident of oral and maxillofacial surgery
Other areas of specialty/work
Street address
Maxillofacial operating room, Imam Khomeini Hospital, Azadegan Boulevard, Research Deputy of Imam Khomeini Hospital