Protocol summary

Study aim
Evaluation of the effect of low power laser in reducing the pain of mandibular block injection
Design
A clinical trial with a control group, with a parallel, double-blind, randomized group, on 59 patients, the RANDBETWEEN command of Excel software was used for randomization.
Settings and conduct
For each patient, two injections of the alveolar block in the posterior area of ​​both sides of the mandible will be performed twice in two weeks at the dental school. In the first session, for all patients, mandibular molar restoration is performed on the right side. For this purpose, using a table of random numbers, people are divided into two groups: laser and placebo. In the second session, restoration is performed on the left tooth and the methods are changed in such a way that patients who received a laser in the first session receive a placebo on the left side and patients who received a placebo receive a placebo this time on the left side. Left receive the laser. The patient and the outcome assessor will be blind during the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: general health, insensitivity to lidocaine injection, no painkillers, anesthesia, sedation and antidepressant for two weeks, no pregnancy Exclusion criteria include: non-cooperation, sensitivity to injectable drug, more than one injection per person, withdrawal of participants
Intervention groups
The intervention involves the use of a low-power laser before the injection, in the intervention group the laser is irradiated and then the injection is performed.
Main outcome variables
Measurement of pain during injection of mandibular alveolar nerve block

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220227054137N1
Registration date: 2022-03-15, 1400/12/24
Registration timing: retrospective

Last update: 2022-03-15, 1400/12/24
Update count: 0
Registration date
2022-03-15, 1400/12/24
Registrant information
Name
Elahe Vlaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 815 6954
Email address
elahev9@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-23, 1400/12/04
Expected recruitment end date
2022-03-15, 1400/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of low power laser in reducing the pain of mandibular block injection in restorative patients
Public title
Evaluation of the effect of low power laser in reducing injection pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
General health Insensitivity to lidocaine injection No use of any analgesics, anesthesia, sedation and antidepressant for two weeks No pregnancy
Exclusion criteria:
Lack of cooperation Sensitivity to the injectable drug If for any reason during the intervention more than one injection is applied for each person Cancellation of the participants Very high and low pain threshold
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 59
More than 1 sample in each individual
Number of samples in each individual: 2
Given that two injections are given for each person, each person will give us two samples to compare the effect of the laser in reducing pain.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done only in the first session in a simple and individual way. A table of random numbers is used for randomization. In Excel software environment, four-digit codes are generated using the RANDBETWEEN command. Each patient is assigned a 4-digit code that if the end digit to the right of the code is 1, 2, 5, 7, 9, at the first visit, they will be given laser radiation, and if the end digit of the code is 0, 3, 4, 6, 8 In the second visit, laser radiation is performed for them. All codes are recorded on paper and stored in specific envelopes. The envelopes are arranged randomly and the responsible secretary, who is aware of the objectives of the study, will give them one of these envelopes before entering the doctor's room when reviewing the inclusion criteria and recording patient information.The secretary is not aware of the study hypothesis and is not aware of the details of the codes for assigning to groups. The doctor will decide on the treatment process for the patient based on the specified code.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is designed in two forms. Patients are not exposed to the laser radiation. For this purpose, when the laser is not irradiated, the device is still on, which makes the patient unaware of whether the device is on or not by making a sound. Also, the outcome assessor is not in the process of allocating patients. Therefore, they are also unaware of how to allocate.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of kermanshah University of Medical Sciences
Street address
Boostan dormitory , zakaria Razi Blv
City
Kermanshah
Province
Kermanshah
Postal code
7461168617
Approval date
2022-02-23, 1400/12/04
Ethics committee reference number
IR.KUMS.REC.1400.800

Health conditions studied

1

Description of health condition studied
Evaluation of the effect of low power laser in reducing the pain of mandibular block injection
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Measurement of pain during injection of mandibular alveolar nerve block
Timepoint
Start of study and 14 days after intervention
Method of measurement
The method of measuring pain intensity is the use of a visual analog scale.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For each patient, two injections of alveolar block in the posterior area of ​​both sides of the mandible will be performed twice in two weeks. In the first session, for all patients, mandibular molar restoration is performed on the right side. For this purpose, using a table of random numbers, people are divided into two groups: laser and placebo. In the second session, restoration is performed on the left tooth and the methods are changed in such a way that patients who received a laser in the first session receive a placebo on the left side and patients who received a placebo receive a placebo this time on the left side. Left receive the laser. The interval between the first and second session is at least two weeks. The patient opens his mouth wide.We see a mucosal protrusion from almost behind the upper tuberosity, which extends to the back of the lower 7 tooth and is called the trigomandibular ridge. Near the trigeminal raphe is where the needle enters the corner of the mouth and about 2 cm of the needle is inserted to hit the bone. In the control group, the device is on, but the laser is not emitted. In fact, the patient is not aware that the laser is on or off and hears the false sound of the device.Settings of low power laser device with specifications: low power laser, quick lase 810nm + 980nm, 12w Dual cw (manufactured by Quick Liz UK, energy 0.3 joules, time s240, cross section 225 mm2, by contact method without pressure Apply perpendicular to the contact area by the first performer and immediately inject a 4% carpol lidocaine (epinephrine 1: 100000).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah School of Dentistry
Full name of responsible person
Elahe vlaee
Street address
Boostan Dormitory , Zakaria Razi Blv
City
Kermanshah
Province
Kermanshah
Postal code
7461168617
Phone
+98 83 3428 1374
Email
elahev9@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Zohreh Rahimi
Street address
Kermanshah, Daneshgah St., School of Medicine, Vice Chancellor for Research and Technology
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4621
Email
zrahimi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
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
Kermanshah University of Medical Sciences
Full name of responsible person
Zohreh Rahimi
Position
University Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Kermanshah, Daneshgah St., School of Medicine, Vice Chancellor for Research and Technology
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 9917
Email
Zrahimi@kums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Elahee vlaee
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Boostan Dormitory , Zakaria Razi Blv
City
Kermanshah
Province
Kermanshah
Postal code
7461168617
Phone
+98 83 3428 1374
Email
elahev9@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Elahe vlaee
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Boostan Dormitory , Zakaria Razi Blv
City
Kermanshah
Province
Kermanshah
Postal code
7461168617
Phone
+98 83 3428 1374
Email
elahev9@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
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