Comparing the effect of photobiomodulation therapy by two types of infrared and red lasers on pain perception of infra alveolar nerve block anesthesia injection in 6-9 years old children
Comparing the effect of photobiomodulation therapy by two types of infrared and red lasers on pain perception of infra alveolar nerve block anesthesia injection in 6-9 years old children
Design
A clinical trial ,triple blind ,randomized ,sealed envelope were used for randomization
Settings and conduct
6-9-year-old patients in need of pulpotomy treatment of milky second molar teeth on both sides of the mandible are included in the intervention. Patients who do not have a bad dental experience will be included to eliminate the effect of the child's previous stressful or painful experience. The study will be conducted on two days, one week apart. Patients in both groups will receive both interventions, with the only difference being the day when infrared or red laser therapy is performed. Randomization to determine which intervention on the right or left and on the first or second day it should be implemented, it is done. Before any intervention, the medical history of patients with their parents should be re-evaluated. For group A, infrared laser irradiation and then anesthetic injection will be done on the first day.In the second visit, red laser and then anesthetic injection will be done.
In group B, red laser radiation and then anesthetic injection will be done on the first day. In the second session, infrared laser radiation and then injection will be done.
The place where the study was conducted is Shahid Beheshti School of Dentistry.
Participants/Inclusion and exclusion criteria
*Patients who need pulpotomy of left and right primary mandibular second molars under inferior alveolar nerve block*
*Children with Frankel level 3 and 4*
*Children 6-9 years old*
Intervention groups
Experimental group: infrared and red lasers
Main outcome variables
Severity of injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210914052474N3
Registration date:2024-05-02, 1403/02/13
Registration timing:registered_while_recruiting
Last update:2024-05-02, 1403/02/13
Update count:0
Registration date
2024-05-02, 1403/02/13
Registrant information
Name
Fatemeh Shekarchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2217 5350
Email address
f.shekarchi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-06, 1403/01/18
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of photobiomodulation therapy by two types of infrared and red lasers on pain perception of infra alveolar nerve block anesthesia injection in 6-9 years old children
Public title
Comparing the effect of infrared and red lasers on pain perception of infra alveolar nerve block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need pulpotomy of left and right primary mandibular second molars under inferior alveolar nerve block
Children with Frankel level 3 and 4
Children 6-9 years old
Exclusion criteria:
History of sensitivity to anesthetics
History of any systemic disease
Age
From 6 years old to 9 years old
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:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Primary mandibular second molars
Randomization (investigator's opinion)
Randomized
Randomization description
The study was done in a split mouth. Sealed envelopes are used for randomization.
In this way, envelopes are randomly selected to determine whether to use red or infrared laser treatment in the first session.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patient is blinded by putting shield glasses on his/her eyes and thus he/she is unaware of the wavelength used.
The operator who performed the anesthetic injection will be different from the person who performed the infrared or red laser radiation.
Therefore, injection and laser radiation will be performed blindly.
In addition, the person who evaluates the scores and analyzes the data will also be unaware of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Heart rate recorded by pulse oximeter during injection
Timepoint
During injection
Method of measurement
Pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 808nm laser: in the area of 0.5 cm2 , with a power of 250 mw, an energy density of 30 j/cm2 and a power density of 0.4 w/cm2 for a period of 75 seconds in the block injection area.
Category
Treatment - Devices
2
Description
Intervention group: 660nm laser:in the area of 0.5 cm2, with a power of 150 mw, an energy density of 30 j/cm2 and a power density of 0.24 w/cm2 for a period of 125 seconds in block injection area.
Category
Treatment - Devices
3
Description
Intervention group: after using the desired laser on the block injection site, infraalveolar nerve block injection is performed with 2% lidocaine anesthetic and 1:100,000 epinephrine from Exir company.
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
The recorded data can be shared based on the studied indicators after identifying the sample individuals. These data include the numbers and scores reported from the Wong Baker FACES pain rating scale, and numbers recorded from the finger pulse oximeter at specified times, as well as results of statistical analysis of these data.
When the data will become available and for how long
e.g., starting 6 months after publication
To whom data/document is available
Researchers working in academic and scientific institutes can apply for access to data
Under which criteria data/document could be used
Performing statistical analyzes to compare data with other studies in this field is one of the conditions for access to data, so the analysis must be appropriate to the type of the data received from the applicant.
From where data/document is obtainable
Applicants can obtain access to the data by submitting a request to the following email addresses in due time:
faeze.abedi78@gmail.com
fshekarchi92@gmail.com
What processes are involved for a request to access data/document
After submitting the request by email, the applicant will be able to access the information within one week after submitting the request, if he/she has the requisite conditions.