Evaluation of the Effect of Low-level Laser Therapy on the Neurosensory Disturbances Following Inferior Alveolar Nerve Lateralization Surgery: A Randomized Clinical Trial
The aim of this study is to evaluate the effect of low-power laser on neurosensory disturbance following inferior alveolar nerve lateralization surgery.
Design
A randomized controlled clinical trial with parallel double blind randomised groups
Settings and conduct
Patients undergoing bilateral inferior alveolar nerve lateralization surgery in privet office are randomly divided in to two groups for each patient one side will iradiated by low level laser and the other side will take placebo laser neurosensory examinations are performed once before surgery for the criterion and three times after surgery at one month three months and six months the exams are repeated and compared to the opposite side that did not receive the laser
Participants/Inclusion and exclusion criteria
Patients Applicant for Dental Implant Therapy on Both Posterior Mandible with Insufficient Bone Height who candidates for inferior alveolar nerve lateralization surgery Without the following conditions
History of facial fractures
History of long term headache
Psychological disorders
Neurologic disorders
Diabetes
History of taking anti epileptic drugs
Clear nerve damage during surgery
Pregnancy
Intervention groups
The intervention in this study is the use of low-power laser on one side of patients undergoing bilateral lower alveolar nerve lateralization The other side will be the control group and will receive the low-power laser placebo
Main outcome variables
The five specific tests for neurosensory evaluation are the main outcome variables that are
Visual analogue scale ; Pain discrimination test ; Two point discrimination test ; Directional discrimination test ; Cold discrimination test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200123046230N1
Registration date:2020-02-22, 1398/12/03
Registration timing:registered_while_recruiting
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
Registrant information
Name
Arash Azaripour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6638 4856
Email address
arashazaripour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Low-level Laser Therapy on the Neurosensory Disturbances Following Inferior Alveolar Nerve Lateralization Surgery: A Randomized Clinical Trial
Public title
Evaluation of the Effect of Low-level Laser Therapy on the Neurosensory Disturbances Following Inferior Alveolar Nerve Lateralization Surgery: A Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Applicant for Dental Implant Therapy on Both Posterior Mandible with Insufficient Bone Height who candidates for inferior alveolar nerve lateralization surgery
Exclusion criteria:
History of facial fractures
History of long term headache
Psychological disorders
Neurologic disorders
Diabetes
History of taking anti epileptic drugs
Clear nerve damage during surgery
Pregnancy
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Each participant is assigned two sample one mandibular side takes laser and the other side does not take
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization is performed with the coin toss for each participant and receives one side based on the laser coin toss
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining consent from patients, randomly assigned to the case group (low power laser) and control group (no laser irradiation) for each patient The device is switched off and the patient assumes that both sides are laser treated
The researcher is also unaware of the laser being irradiated and the laser treatment process is performed by the technician
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Azad University of Medical Sciences - Faculty of Dentistry
Street address
No. 112 , Hodhod 1 building , North navab highway
City
Tehran
Province
Tehran
Postal code
1319813719
Approval date
2018-05-27, 1397/03/06
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.024
Health conditions studied
1
Description of health condition studied
Inferior alveolar nerve neurosensory disturbance
ICD-10 code
G50.8
ICD-10 code description
Other disorders of trigeminal nerve
Primary outcomes
1
Description
Sensory function of the inferior alveolar nerve
Timepoint
Before surgery and 1, 3 and 6 months after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Surgery will be performed by one of the experienced professors with the same standard protocol and materials. After surgery, the intervention group was treated with laser therapy with a 0.3 watt diode laser and 6 joule power (InGaAlP; wavelength 660nm; Thor DD2 Control Unit, Thor, London, UK) for 8 sessions at 72 intervals. It will be placed in the oral alveolar nerve pathway orally for 20 seconds per square centimeter per session.
Category
Treatment - Devices
2
Description
Control group: Surgery will be performed by one of the experienced professors with the same standard protocol and materials. After surgery, the control group is exposed to placebo laser irradiation with a 0.3 watt laser diode and 6 joules of power (InGaAlP; wavelength 660nm; Thor DD2 Control Unit, Thor, London, UK ) In 8 sessions at 72 hours intervals for 20 seconds per square centimeter, the inferior alveolar nerve pathway will be inhaled orally but the device will be switched off and the laser will not be illuminated
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Buali hospital of tehran
Full name of responsible person
Arash Azaripour Esfahani
Street address
Damavand Street
City
Tehran
Province
Tehran
Postal code
17117
Phone
+98 21 3334 8036
Fax
Email
booali.hospital96@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Dentistry, Islamic Azad University of Medical Sciences
Full name of responsible person
Arash Azizi
Street address
Ninth Neyestan , Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
arashazizi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Faculty of Dentistry, Islamic Azad University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Private
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
Faculty of Dentistry, Islamic Azad University of Medical Sciences
Full name of responsible person
Arash Azaripour Esfahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 112 , Hodhod building 1 , North Navab Highway
City
Tehran
Province
Tehran
Postal code
1319813719
Phone
+98 21 6638 4856
Email
arashazaripour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry, Islamic Azad University of Medical Sciences
Full name of responsible person
Arash azaripour Esfahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 112 , Hodhod Building 1 , North Navab Highway
City
Tehran
Province
Tehran
Postal code
1319813719
Phone
+98 21 6638 4856
Email
arashazaripour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Dentistry, Islamic Azad University of Medical Sciences
Full name of responsible person
Arash Azaripour Esfahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 112 , Hodhod 1 building , North Navab Highway
City
Tehran
Province
Tehran
Postal code
1319813719
Phone
+98 21 6638 4856
Email
arashazaripour@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
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Main outcome information
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Shoal scholars in academic institutions
Under which criteria data/document could be used
With the written permission of the researcher
From where data/document is obtainable
By mail to researcher: arashazaripour@gmail.com
What processes are involved for a request to access data/document