Clinical Trial to Comparison of Fracture Healing between Closed Reduction Surgery Alone and in Combination with Pulsed Magnetic Filed in Patients with Mandibular Fracture
Objectives: Considering the role of pulsed electromagnetic field on repair of Non-Union bones, the plan is designed to investigate the effect of pulsed electromagnetic field on mandibular fracture healing.
Design: The project will be implemented by way of clinical trial. Cases will be selected among the patients referred to Taleghani Hospital for treatment of mandibular fracture with close reduction method.
Design: In this randomized clinical trial study, of those who did undergo closed reduction in Taleghani hospital, 32 patients were selected sequentially and were divided in 2 different groups (control=16, treatment=16) randomly with flip the coin method.
Setting & Conduct: After Operation The fracture sites of group T expose to pulsed electromagnetic fields (PEMF) for 6 hours immediately. Then repeat this procedure on the 7th day for 3 hours and on the 14th day for 1.5 hours. In Treatment group, the MMF will be removed at fourth weeks after surgery and in control group at sixth weeks. The effectiveness of the treatment modalities evaluate clinically and radiographically using computerized densitometry by direct digital panoramic machine.
Inclusion/exclusion criteria: Inclusion criteria included the mandible fracture in dental region; existence of enough dental contacts in both sides of fracture line; absence of signs of infection in fracture region; lack of systemic diseases affecting favorable stages of bone regeneration.
Intervention: Exposer to pulsed electromagnetic fields (PEMF)
Main outcomes measures: Changes in bone mineral density, The post-operative pain, The maximum amount of open mouth, Sensory changes.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016022526769N1
Registration date:2016-12-17, 1395/09/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-17, 1395/09/27
Registrant information
Name
Hassan Mohajerani
Name of organization / entity
Dental school, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 9203
Email address
mohajerani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial to Comparison of Fracture Healing between Closed Reduction Surgery Alone and in Combination with Pulsed Magnetic Filed in Patients with Mandibular Fracture
Public title
Clinical Trial to Comparison of Fracture Healing between Closed Reduction Surgery Alone and in Combination with Pulsed Magnetic Filed in Patients with Mandibular Fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included the consent of participating in study, mandible fracture in dental region, existence of enough dental contacts in both sides of fracture line that possibility of application of arch bar and maxillary mandibular fixation (MMF) establishment exists, absence of signs of infection in fracture region, lack of systemic diseases affecting favorable stages of bone regeneration, treatment indications of closed reduction. Exclusion criteria included lack of consent of participating in study and contraindications of closed reduction treatment
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomizated with Flip the Coin Method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ettichs Committe of Shahid Beheshti University of Medical Sciences
Street address
Ettichs Committe, Shahid Beheshti University of Medical Sciences, Daneshjoo Sq., Evin st., Tehran-Iran.
City
Tehran
Postal code
۱۹۸۳۹۶۳۱۱۳
Approval date
2016-07-02, 1395/04/12
Ethics committee reference number
ir.sbmu.rids.rec.1395.212
Health conditions studied
1
Description of health condition studied
Mandible fx
ICD-10 code
S02.6
ICD-10 code description
Lower jaw (bone)
Primary outcomes
1
Description
Changes in bone mineral density
Timepoint
Befor Operation, 2 weeks & 4 weeks later
Method of measurement
Radio densitometry
2
Description
The post-operative pain
Timepoint
Operation Day, One day later & one week & two weeks later
Method of measurement
Visual Analog Scale (VAS)
3
Description
The maximum amount of open mouth
Timepoint
End of treatment
Method of measurement
Caliper Vrnyr
4
Description
Sensory changes
Timepoint
Prior to operation, a month later, two months later
Method of measurement
Patient verbal affirmation of abnormal lip sensation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, fracture sites expose to pulsed electromagnetic fields (PEMF) for 6 hours immediately after surgery. Then, this procedure will repeat on the 7th day for 3 hours and on the 14th day for 1.5 hours. The MMF (mandibular fixation) will be removed at fourth weeks after surgery.
Category
Other
2
Description
Control group: Only treatment of Mandibular fracture with closed reduction method. The MMF will be removed at sixth weeks.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital, Shahid Beheshti University of Medical Sciences