Double blind randomized clinical trial of therapeutic effect of low level laser therapy on acute pain and mouth openning after closed redution of condylar fracture.
Evaluation of the therapeutic effect of low-level laser therapy on acute post-operative pain an mouth opening in patients undergone a closed reduction of the temporomandibular joint fracture.
Design
A randomized double blind clinical trial consisting of two groups each one has 20 cases, will be performed from June 2020 till September 2020.
Settings and conduct
The study will be performed in the department of oral and maxillofacial surgery of Kerman Bahonar hospital and Kerman university of dentistry. Both patients and researcher aren't aware of the type of intervention and the operator is the only person who knows the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women with an isolated traumatic fracture of temporomandibular joint which are closed-treatment candidates.
Exclusion criteria: patient suffering pathologic fracture, patient with fracture which needs to be treated with open surgery, pregnant women, underaged patient with mixed dentition, edentulous patients, patient with a known history of pain diseases, patient with intellectual disability who are not able to fill in the questionnaire
Intervention groups
Control group: Use of inactive LLT+standard protocol of closed reduction of the temporomandibular fracture.
Intervention group: Use of inactive LLT+ standard protocol of closed reduction of the temporomandibular joint.
Main outcome variables
Visual Analogue Scale(VAS), Degree of mouth opening measured by interincisal distance in millimeters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200520047519N1
Registration date:2020-06-09, 1399/03/20
Registration timing:prospective
Last update:2020-06-09, 1399/03/20
Update count:0
Registration date
2020-06-09, 1399/03/20
Registrant information
Name
arash bahari bandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 9021
Email address
a.bahari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double blind randomized clinical trial of therapeutic effect of low level laser therapy on acute pain and mouth openning after closed redution of condylar fracture.
Public title
Evaluation of effect of laser on TMJ fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Trauma patients whith TMJ fracture that need cosed reduction(archbar and maxillomandibular fixation).
Exclusion criteria:
Subcondylar fractures that need Open Reduction and Internal Fracture(ORIF)
Pathologic fractures
Patient who cannot complete follow-up sessions
Patient with craniafacial deformity
Pregnant woman
Patien that aren't bale to fill in questionnaire
Patients who suffer from major associated traumatic injuries or systemic conditions.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed utilizing computer software using block randomization method and 5 patient within a block
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient and the person who evaluate the treatment outcomes will be blind to the patient's groups. During the first visit, patients will be explained about the probability of being chosen for any of the groups. Before treatment sessions, one of the staff who is not involved in the research will extract the patient information from a sealed envelope and will deliver the laser device's parameters to an operator who either is not involved in the research. Patients and the practitioner won't be informed about the method which has been used. The device's sound is similar for both groups and all patients will be blindfolded by the security eyewear.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical aciences.ical science
Street address
kerman University of Medical Science, Medical University Campus, Haftbagh ighway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7618759689
Approval date
2020-06-09, 1399/03/20
Ethics committee reference number
IR.KMU.REC.1399.148
Health conditions studied
1
Description of health condition studied
Temporomandibular Joint Fracture
ICD-10 code
S02.92XA
ICD-10 code description
Unspecified fracture of facial bones, initial encounter for closed fracture
Primary outcomes
1
Description
Acute postoperative pain in a patient who have undergone a close reduction of temporomandibular joint fracture
Timepoint
VAS will be recorded 24, 48 and 72 hours after surgery.
Method of measurement
Visual Analogue scale
2
Description
Degree of mouth opening
Timepoint
7 days after surgery
Method of measurement
ruller
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Gallium–Aluminum–Arsenide laser, 808nm, 3J/cm3, 20 s sessions of laser therapy will be performed while the probe tip has aproximately 2mm distance from skin surface, on 14 extra oral points (8 points on masseter, 2 poin in pre auricular are, 2 submandibular and 2 point in jugulodigastric area). each time an area of 1.5 mm2 will be treated.
Category
Treatment - Devices
2
Description
Control group: Intervention in this group will be the same as the intervention1 except the device will be used in inactive mode.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and Maxillofacioal surgery Department- Kerman Bahonar Hospital
Full name of responsible person
Saeid Hajmohammadi
Street address
Qarani St.
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
arash.bahari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Moluk Torabi
Street address
Shafa St.
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3211 8074
Email
arash.bahari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?