Comparison of the effect of superficial anesthesia with 20% benzocaine gel and low power laser on reducing pain perception of infiltrate anesthesia injection in 6-12 years old children
Design
Children referred to the pediatric department of Alborz University of Medical Sciences are divided into two groups of boys and girls. Each case is assigned a number. Then the numbers are written on separate cards and randomly drawn 22 cards between girls and boys. Twenty-three cards were selected from the boys. 45 subjects were selected, one using laser anesthesia and the other with a gel, so the sample size was 45 in each control and intervention group. The study is a double-blind clinical trial.
Settings and conduct
n the control group, the anesthetic injection site is dried and the benzocaine gel applied to the area, and the laser pen is held in place, followed by a short needle injection of lidocaine by the dentist. Drying, placebo cotton swabs are kept in place and prepared by laser power and then anesthesia is injected. The degree of pain perception in both groups is recorded by another person using visual analogue scale scales. And the child and the researcher who record the information are unaware of the anesthetic procedure
Participants/Inclusion and exclusion criteria
Inclusion criteria: Among 6-12 children who need treatment of bilateral maxillary first and second primary molars with infiltrate injection.
Exclusion criteria: Among children who have a pacemaker or have systemic problems are excluded from the sample.
Intervention groups
12- to 6-year-old children who received anesthetic injection of 20% benzocaine gel for 30 seconds with cotton swab on dry mucosa (control) / 12- to 6-year-old children who were treated with infrared laser therapy for 60 seconds. (Intervention).
Main outcome variables
Understand injection pain in children, child cooperation with treatment staff.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200118046178N1
Registration date:2020-02-25, 1398/12/06
Registration timing:registered_while_recruiting
Last update:2020-02-25, 1398/12/06
Update count:0
Registration date
2020-02-25, 1398/12/06
Registrant information
Name
maryam jahangiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4448 4289
Email address
jahangiri74mj.mj@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analgesic effects of pre-infiltration injection topical benzocaine 20% and low-level layser in 6_12 year old children:A randomized clinical trial
Public title
analgesic effect of lowlevel laser in pediatric dentistry
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
12-6 years old children who need restoration treatment of first and second maxillary deciduous teeth
Exclusion criteria:
Having pace maker
Suffering from systemic disease
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
45
More than 1 sample in each individual
Number of samples in each individual:
2
Analgesic injection for restoration treatment of maxillary both sides
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization Method and Individual Unit - Children will be divided into two groups of boys and girls and each case will be assigned a number and the numbers will be written on separate cards and randomly assigned to the numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
1-In this study for distraction of child and having no impression on VAS(visual analouge scale) keep off laser pen in the part which need no radiation.
2-During study,one of the researchers injects with different ways while the other who records and analyses outcome have no idea about the methods.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz university of medical sience
Street address
Alborz University of Medical Sciences,Azimieh Administrative Town,Taleghani Square,Karaj
City
Karaj
Province
Alborz
Postal code
3198684868
Approval date
2019-12-14, 1398/09/23
Ethics committee reference number
IR.ABZUMS.REC.1398.184
Health conditions studied
1
Description of health condition studied
Dental analgesic
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of pain injected
Timepoint
Immediately after anesthesia injection
Method of measurement
Visual analoug scale emoji
Secondary outcomes
1
Description
Engage child cooperation
Timepoint
During treatment
Method of measurement
Questionnaire from the therapist
Intervention groups
1
Description
Intervention group: 6 to12 years old children who were given infrared laser therapy with injection of 0.2 watts and energy of 8 joules per point for 60 seconds before injection. therapy before injection
Category
Treatment - Devices
2
Description
Control group: Children 6 to 12 years of age who have received 20 precent benzocaine gel injection prior to anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric ward of Alborz Dental School
Full name of responsible person
Maryam Jahangiri
Street address
Department of Pediatrics, Alborz School of Dentistry, Ketoozadeh St., Golshahr, Iran
City
karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3355 5049
Email
jahangiri.m.1995@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Maryam Jahangiri
Street address
Department of Pediatrics, Alborz School of Dentistry, Ketoozadeh St., Golshahr, Karaj ,Iran
City
Karaj
Province
Alborz
Postal code
3198684868
Phone
+98 26 3355 5049
Email
jahangiri.m.1995@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Department of Pediatrics, Alborz School of Dentistry, Ketoozadeh St., Golshahr, Iran
City
Karaj
Province
Alborz
Postal code
3149969415
Phone
009826335311614
Email
jahangiri.m.1995@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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Patient information such as age, gender, type of treatment received, and method of anesthesia and pain level can be disclosed with ethical and confidentiality guidelines.
When the data will become available and for how long
Access started from 1400
To whom data/document is available
Anyone interested in research or work in the field.
Under which criteria data/document could be used
1.There is a justified reason for obtaining the documentation.
2. Have a university degree or research related job
From where data/document is obtainable
Send an email to jahangiri74mj.mj@gmail.com
What processes are involved for a request to access data/document
After submitting the email containing the request, the request will be shared with other project partners and after obtaining their consent, the administrative steps involved in communicating with the Alborz University of Medical Sciences will be made available to applicants if the university permits.