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The comparison of 940nm and 810nm diode laser type effects on the repair of inferior alveolar sensory nerve damage

Protocol summary

Study aim
Determination of the effect of two types of 940nm and 810nm diode lasers on repair of infra-aleuolular sensory nerve injury in patients referred to Laser Research Center of the Faculty of Dentistry, University of Tehran during the year 1397-98.
Design
Clinical trials with control group, with parallel groups, blind, randomized
Settings and conduct
The first and second groups underwent irradiation of the infra-alluvial nerve pathway in three regions, including nerve insertion into the mandibular position of Foramen, Lip and one region in the two regions. The treatment will continue for 12 sessions (3 days a week). In each session, laser radiation with a power of 400mW in 20 seconds for each area is done. The area of each area under the radiation is 1 cm2 and the radiation dose per session is 8 J / cm2.
Participants/Inclusion and exclusion criteria
Less than six months have suffered a nerve damage due to dental treatment and have not undergone any treatment.
Intervention groups
Patients are divided into three groups: 1) under 810nm laser irradiation, 940nm laser irradiation, and 3) non-radiation laser (control group).
Main outcome variables
Four objective tests and a subjective test will be used to evaluate nerve repair. For all individuals, a full-scale clinical neurosensory test (CNT), including A (Brush stroke and 2-point discrimination), Bpr (pinprick nociception and thermal discrimination), will be performed. The intensity of fidelity and satisfaction is assessed using the Numerical Scale (0 is not at all satisfied - 10 is fully satisfied) and CNT will be evaluated before and after the treatment (after the first, third, seventh, and twelfth days).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190520043644N1
Registration date: 2019-12-15, 1398/09/24
Registration timing: retrospective

Last update: 2019-12-15, 1398/09/24
Update count: 0
Registration date
2019-12-15, 1398/09/24
Registrant information
Name
Hooman Ebrahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8867 3895
Email address
hooman.ebrahimi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-27, 1398/03/06
Expected recruitment end date
2019-08-28, 1398/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of 940nm and 810nm diode laser type effects on the repair of inferior alveolar sensory nerve damage
Public title
Effect of laser diode on the repair of inferior alveolar sensory nerve damage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
With sensory and neuropathic disturbances Sensory nerve damage due to dental treatments Less than 6 months of injury Treated with laser Systemic diseases
Exclusion criteria:
Sensory nerve damage is due to trauma Already exposed to laser radiation History of drug addiction Smoking
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 39
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method consists of a quadrilateral random block In this method the size of the blocks is selected at random Each block contains an equal number of each group For ethical consideration and standard treatment, all patients were treated with vitamin B1 300 mg once daily and gabapentin 100 mg once daily Then patients are divided into three groups: 810nm diode laser, 940nm diode laser irradiation and no laser irradiation (control group)
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient does not know what diode (940nm laser diode or 810nm laser diode or normal diode) will light up his nerve. Clinical supervision of the device and only diode light to the patient's nerve and is not known about the type of diode used. The outcome evaluator will only review the patient and record the result in a file that does not use the type of diode he or she uses.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Department of Dentistry, Islamic Azad University, Tehran, Iran
Street address
No. 9, Neyestan 9 Ave., Pasdaran Plvd.
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2019-05-04, 1398/02/14
Ethics committee reference number
IR.IAU.DENTAL.REC .1398.008

Health conditions studied

1

Description of health condition studied
Inferior alveolar sensory nerve damage
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia

Primary outcomes

1

Description
The number of people with a fatigue rating above 3
Timepoint
After the sessions 1, 3, 7 and 12 treatment
Method of measurement
Numerical Scale

2

Description
The number of people who tested the clinical neurosensory test
Timepoint
After the sessions 1, 3, 7 and 12 treatment
Method of measurement
Brush Stroke test with the criterion for detecting one of two horizontal and vertical movements, Two Point Discrimination test with a minimum recording distance of less than 10 mm, Thermal Discrimination test with a heat and cold detection criterion, and a Pin Prick Nociception test with a metric for registering more hits. From 30%

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Under the 810 nm diode laser beam 810nm Laser: Diode laser with GaAlAc medium (Gallium Aluminum Arsenide) with 810nm wavelength manufactured by Thor UK Different Sessions: The first three days of the seventh to the twelfth hour Treatment Specifications: At each session, 400mW laser irradiation in twenty seconds for the three nerve entry sites to the mandibular foramen, lip, and one area between these two regions is equal to 1cm2 of Spot Area
Category
Treatment - Other

2

Description
Intervention group: Under the 940nm diode laser beam 940nm Laser: 940nm Medium GaInP (Gallium Endium Phosphate) Diode Laser Made by US Biolase Different Sessions: The first three days of the seventh to the twelfth hour Treatment Specifications: At each session, 400mW laser irradiation in twenty seconds for the three nerve entry sites to the mandibular foramen, lip, and one area between these two regions is equal to 1cm2 of Spot Area
Category
Treatment - Other

3

Description
Control group: No intervention For ethical consideration and standard treatment, all patients were treated with vitamin B1 300 mg once daily and gabapentin 100 mg once daily
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Laser Research Center, Faculty of Dentistry, University of Tehran
Full name of responsible person
Hooman Ebrahimi
Street address
End of Worker North - Next to Hakim Highway - Tehran Dental School-
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 8801 5950
Email
dentistry@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash azizi
Street address
No. 9, Neyestan 9 Ave., Pasdaran Plvd.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
hooman.ebrahimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Hooman Ebrahimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Neyestan 9 Ave., Pasdaran Plvd.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
hooman.ebrahimi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hooman Ebrahimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Neyestan 9 Ave., Pasdaran Plvd.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
hooman.ebrahimi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Kargar
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, Neyestan 9 Ave., Pasdaran Plvd.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
fmm.kargar@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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