Investigating the efficacy of 810 nm low power diode laser in reducing pain caused by anesthetic injection in dental treatments by the doctor of the restorative department of Zanjan Dental School.
Assessing pain levels resulting from anesthesia injection in dental patients within the control group.
Evaluating pain levels resulting from anesthesia injection in dental patients undergoing treatment with 810 nm low power diode laser.
Comparing the pain experience between the control group and patients receiving 810 nm low power diode laser treatment during dental anesthesia injections.
Design
Randomization was done based on block randomization methods with a volume of 4 (blocked randomization was for the purpose of making sure that exactly equal number of participants entered the intervention and control groups at consecutive but equal time intervals). First, the samples were entered into the study, then they were assigned to two groups using random blocks with a volume of 4 people. The order of the blocks and also the order of the groups within the blocks were random. The blocks were prepared using R software and provided to the therapist. In the present study, block randomization was used to allocate people to intervention groups
Settings and conduct
Zanjan University of Medical Sciences
Participants/Inclusion and exclusion criteria
1. Patients in the age group over 12
2. Patients who were willing to participate in the study while having informed written consent.
3. Patients who needed repair and therefore anesthesia injection.
4. Absence of inflammation or local sensitivity at the injection site
5. Being healthy
No entry: patients with severe anxiety
Intervention groups
People receiving low power laser
Main outcome variables
Pain level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230619058531N1
Registration date:2024-02-19, 1402/11/30
Registration timing:prospective
Last update:2024-02-19, 1402/11/30
Update count:0
Registration date
2024-02-19, 1402/11/30
Registrant information
Name
Alireza Ganjkhanlo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 0219
Email address
alirezakhanloznj@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-04, 1402/12/14
Expected recruitment end date
2024-04-02, 1403/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the efficacy of 810 nm low power diode laser in reducing pain caused by anesthetic injection in dental treatments by the doctor of the restorative department of Zanjan Dental School.
Public title
Investigating the efficacy of 810 nm low power diode laser in reducing pain caused by anesthetic injection in dental treatments by the doctor of the restorative department of Zanjan Dental School.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need repair and therefore anesthesia injection.
Patients with caries
Exclusion criteria:
Patients with severe anxiety
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In the current study, the blocking method will be used to balance the number of samples assigned to each of the studied groups. The size of the blocks will be chosen randomly. A block size of 4 will be calculated and determined for this study. Subsequently, a randomization list will be generated to specify the treatment allocation for each participant within each block. As participants are enrolled in the study, they will be assigned to the next treatment group based on the randomization list within the corresponding block.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher herself knows about laser radiation or non-radiation, but patients do not know about laser radiation or non-radiation due to lack of knowledge about laser function.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Medical Sciences
Street address
Zanjan, at the end of Mahdavi Boulevard, Zanjan University of Medical Sciences, Faculty of Dentistry
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2023-06-06, 1402/03/16
Ethics committee reference number
IR.ZUMS.REC.1402.073
Health conditions studied
1
Description of health condition studied
ِDental caries, Pain , Stress
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Pain intensity based on Visual Analogue Scale
Timepoint
1 day after the intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control: Receiving local anesthesia, which includes 2% lidocaine anesthetic, which is injected as an infiltrate.
Category
Placebo
2
Description
Intervention group: The laser receiver is irradiated by an elexxion brand device with a wavelength of 810 nm and a power of 0.5 watts, which is directly irradiated for 15 seconds before injecting the anesthetic at the injection site.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Medical Science School
Full name of responsible person
Alireza Ganjkhanlo
Street address
Faculty of Dentistry, Zanjan University of Medical Sciences, at the end of Mahdavi St., Zanjan
City
Zanjan
Province
Zanjan
Postal code
438346356
Phone
+98 24 3347 0219
Email
alirezakhanloznj@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samad Nadri
Street address
Zanjan University of Medical Sciences Vice President of Research and Technology, Azadi Square, Azadi Blvd, Zanjan, .,
City
Zanjan
Province
Zanjan
Postal code
4354456644
Phone
+98 24 3347 0219
Email
info@zums.ac.ir
Grant name
Dental student thesis grant
Grant code / Reference number
5222
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Ganjkhanlo
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Zanjan, at the end of Mahdavi Boulevard, Zanjan University of Medical Sciences, Faculty of Dentistry
City
Zanjan
Province
Zanjan
Postal code
4513956111
Phone
+98 24 3347 0219
Email
alirezakhanloznj@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Ganjkhanlo
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Zanjan, at the end of Mahdavi Boulevard, Zanjan University of Medical Sciences, Faculty of Dentistry
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3347 0219
Email
alirezakhanloznj@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Ganjkhanlo
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Zanjan, at the end of Mahdavi Boulevard, Zanjan University of Medical Sciences, Faculty of Dentistry
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3347 0219
Email
alirezakhanloznj@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
All data is accessible
When the data will become available and for how long
From 2025
To whom data/document is available
Students
Under which criteria data/document could be used
Scientific uses and completely free
From where data/document is obtainable
Zanjan University of Medical Sciences
What processes are involved for a request to access data/document