The effect of photobiomodulation on neurosensory recovery of patients with neurotmesis of the inferior alveolar nerve due to mandibular traumatic fracture
Design
A concealed, randomized, triple-blinded clinical trial with 52 patients enrolled between June and July 2020, and followed for one year
Settings and conduct
The clinical trial will be conducted at the Army Dental School and will be triple blinded (including Patients, outcome assessor, and analyzer). Fifty-two patients will be randomly divided into two groups of 26 using Randomizer software (Version 4.0) and 12 sessions of laser therapy will be performed for the intervention group and a laser probe will be placed on the area of the control group turned off.
Participants/Inclusion and exclusion criteria
Patients with a history of complete inferior alveolar nerve severance due to a mandibular fracture who have received standard open reduction and internal fixation and the neurosensory disorder persists for at least 6 months
Intervention groups
For the intervention group, 12 sessions of laser therapy on the area with neurosensory disturbances with diode laser will be performed, while for the control group, the laser probe will be placed on the area turned off.
Main outcome variables
Light Touch Sensation test, 2-Point Discrimination test, Thermal Test, Electric pulp test, Oral Health Impact Profile Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190505043481N1
Registration date:2021-09-20, 1400/06/29
Registration timing:retrospective
Last update:2021-09-20, 1400/06/29
Update count:0
Registration date
2021-09-20, 1400/06/29
Registrant information
Name
Nariman Nikparto
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 7409
Email address
n-nikparto@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-10, 1398/12/20
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
2020-03-10, 1398/12/20
Actual recruitment end date
2020-05-20, 1399/02/31
Trial completion date
2021-05-21, 1400/02/31
Scientific title
The effect of photobiomodulation on neurosensory recovery of patients with neurotmesis of inferior alveolar nerve due to mandibular traumatic fracture
Public title
The effect of laser therapy on lip and chin sensation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of displaced fractures of the mandibular body, angle, or ramus
Displacement of fracture segments in panoramic radiograph should delineate complete nerve severance (Sunderland 5)
Patients who have received ideal treatment of open reduction and internal fixation
At least six months have elapsed since open reduction and internal fixation treatment, and the neurosensory disorder persists.
All patients should be systemically healthy.
Exclusion criteria:
Age
No age limit
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:
52
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Computer software: Randomizer (Version 4.0)
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients, outcome assessor, and analyzer will be blind. Laser therapy will be performed for the intervention group while the laser probe will be placed on the area of the control group turned off. Due to the invisibility of the laser beam and the silence of the probe when turned on, patients will not notice whether the device is turned on or off. The outcome assessor will also evaluate patients in a separate room and will be blind to the patient group. The analyzer will also be blind to the group of patients because the names of the groups will not be in the data.
Placebo
Not 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
AJA University of Medical Sciences, Etemadzadeh St. , West Fatemi st. , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2020-05-27, 1399/03/07
Ethics committee reference number
IR.AJAUMS.REC.1399.044
Health conditions studied
1
Description of health condition studied
chin and lip anesthesia due to mandibular trauma
ICD-10 code
R20.2
ICD-10 code description
Dysesthesia
Primary outcomes
1
Description
Improvement in neurosensory function of inferior alveolar nerve
Timepoint
Baseline, after all 12 sessions and 3,6,9,12 months after last session
Method of measurement
Light touch sensation test with cotton swap
2
Description
Improvement in neurosensory function of inferior alveolar nerve
Timepoint
Baseline, after all 12 sessions and 3,6,9,12 months after last session
Method of measurement
Two-Point discrimination test
3
Description
Improvement in neurosensory function of inferior alveolar nerve
Timepoint
Baseline, after all 12 sessions and 3,6,9,12 months after last session
Method of measurement
Thermal test
4
Description
Improvement in neurosensory function of inferior alveolar nerve
Timepoint
Baseline, after all 12 sessions and 3,6,9,12 months after last session
Method of measurement
Electric pulp test
5
Description
Improvement in neurosensory function of inferior alveolar nerve
Timepoint
Baseline, after all 12 sessions and 3,6,9,12 months after last session
Method of measurement
Oral health impact profile questionnaire
6
Description
Improvement in neurosensory function of inferior alveolar nerve
Timepoint
Baseline, after all 12 sessions and 3,6,9,12 months after last session
Method of measurement
Light touch sensation test with wooden cotton swap
7
Description
Improvement in neurosensory function of inferior alveolar nerve
Timepoint
Baseline, after all 12 sessions and 3,6,9,12 months after last session
Method of measurement
Light touch sensation test with dental needle
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who receive laser therapy on the area with neurosensory impairment in12 sessions with Gallium Aluminum Arsenide diode laser. Control group: Patients who do not receive any intervention and the laser probe will be placed on the area with neurosensory impairment turned off for 12 sessions
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
AJA University of Medical Sciences
Full name of responsible person
نریمان نیک پرتو
Street address
AJA University of Medical Sciences, Etemadzadeh St. , West Fatemi st. , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8888 7409
Email
nnikparto@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
نریمان نیک پرتو
Street address
AJA University of Medical Sciences, Etemadzadeh St. , West Fatemi st. , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8888 7409
Email
nnikparto@gmail.com
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
100
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
Nariman Nikparto
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
AJA University of Medical Sciences, Etemadzadeh St. , West Fatemi st. , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8888 7409
Email
nnikparto@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Behzad Salari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry of Artesh University of Medical Sciences, Misagh Complex, End of 13th East St. , Ajodania, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
021228998983
Email
Behzad.salari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Nariman Nikparto
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
AJA University of Medical Sciences, Etemadzadeh St. , West Fatemi st. , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8888 7409
Email
nnikparto@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
starting after publication for 6 months
To whom data/document is available
for people working in academic institutions
Under which criteria data/document could be used
there are no specific criteria
From where data/document is obtainable
With an email to corresponding author
What processes are involved for a request to access data/document
The accepted proposal from an official committee should be provided and only if our data was relevant to the proposal needs, the data will be sent