Assessment of low level laser therapy (LLLT) on neurosensory recovery in lower face region after maxillofacial trauma; assessment of low level laser therapy (LLLT) on neurosensory recovery in midfacial area after maxillofacial trauma
Design
Two arm parallel group randomised double blind clinical trial. Randomization is done with statistical software.
All patients with bilateral facial injury will participate in this study. Affected sides will be randomly divided into case or control groups.
Settings and conduct
All patients with maxillofacial trauma referred to AJA University of Medical Sciences will be included. Patients and researcher will be kept blind in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with neurosensory disturbance following maxillofacial trauma
Non-inclusion criteria: -
Intervention groups
Applying low-level laser radiation on one affected site ( for example right side ) and no radiation ( turned off device ) on the contralateral affected side ( left side )
Main outcome variables
Improvement of sensory deficit after LLL radiation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190916044784N1
Registration date:2019-10-11, 1398/07/19
Registration timing:prospective
Last update:2019-10-11, 1398/07/19
Update count:0
Registration date
2019-10-11, 1398/07/19
Registrant information
Name
Shahryar Bashirigoudarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4415 7941
Email address
dr.s.bashiri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Photobiomodulation on Neurosensory Disturbance Recovery after Maxillofacial Trauma
Public title
The Effect of Photobiomodulation on Neurosensory Disturbance Recovery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with bilateral neurosensory disturbance after maxillofacial trauma
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization via statistical software (Random Allocation Software) and affected side will be settled into case or control group
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researcher -that is in charge of clinical part- are blinded in this study. The data from clinical intervention sessions will be sent to data collection assistant by code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
AJA University of Medical Sciences
Street address
Unit 27, No 14, South Laleh street, West Ferdos Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1484977554
Approval date
2019-09-15, 1398/06/24
Ethics committee reference number
IR.AJAUMS.REC.1398.136
Health conditions studied
1
Description of health condition studied
Neurosensory deficit after maxillofacial trauma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Neurosensory improvement after trauma in facial area
Timepoint
Before intervention, 4 weeks after intervention, 8 weeks after intervention, 12 weeks after intervention
Method of measurement
Visual Analogue Scale, Two point discrimination test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: LLL radiation in one affected site
Category
Rehabilitation
2
Description
Control group: LLL radiation to contralateral affected side while the device is turned off (placebo effect)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
AJA University of Medical Sciences
Full name of responsible person
Shahryar Bashiri
Street address
AJA university of Medical Sciences, North Kargar St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
aja@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Shahryar Bashiri
Street address
AJA University of Medical Sciences, North Kargar St, Tehran. Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
info@aja.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Shahryar Bashiri
Position
Oral and Maxillofacial Surgeon
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 27, No 14, South Laleh street, West Ferdos Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1484977554
Phone
+98 21 4415 7941
Email
dr.s.bashiri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Shahryar Bashiri
Position
Oral and Maxillofacial Surgeon
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 27, No 14, South Laleh street, West Ferdos Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1484977554
Phone
+98 21 4415 7941
Email
dr.s.bashiri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Shahryar Bashiri
Position
Oral and Maxillofacial Surgeon
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 27, No 14, South Laleh street, West Ferdos Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1484977554
Phone
+98 21 4415 7941
Email
dr.s.bashiri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD