Effect of injection site precooling versus benzocaine gel on pain perception during infiltration local anesthesia of anterior teeth in children: a randomized clinical trial
To assess the effect of injection site precooling versus benzocaine gel on pain perception during infiltration local anesthesia of anterior teeth in children
Design
This is a randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the School of Dentistry in Hamadan city on 52 children who need infiltration local anesthesia of anterior teeth. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 8 to 10 years;
Indication of local anesthetic injection for anterior teeth;
Exclusion criteria:
Presence of abscess and fistula in the injection site;
Systemic diseases or mental disorders
Intervention groups
Intervention group:
Put ice on the injection site for one minute
Control group:
Apply benzocaine gel to the injection site for one minute
Main outcome variables
Primary outcome:
Intensity of pain on the injection site, behavior of the child
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N418
Registration date:2022-03-08, 1400/12/17
Registration timing:prospective
Last update:2022-03-08, 1400/12/17
Update count:0
Registration date
2022-03-08, 1400/12/17
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of injection site precooling versus benzocaine gel on pain perception during infiltration local anesthesia of anterior teeth in children: a randomized clinical trial
Public title
Effect of injection site precooling versus benzocaine gel on pain perception during infiltration local anesthesia of anterior teeth in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 8 to 10 years;
Indication of local anesthetic injection for anterior teeth;
Exclusion criteria:
Presence of abscess and fistula in the injection site;
Systemic diseases or mental disorders
Age
From 8 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare two envelopes, writing in one envelopes the name of the intervention and in another the name of the control. The envelopes will be randomly drawn one at a time for each patient without replacement. This action repeated until the sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-10-18, 1400/07/26
Ethics committee reference number
IR.UMSHA.REC.1400.556
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Primary outcome: Intensity of pain on the injection site pain
Timepoint
Immediately after injection
Method of measurement
Using Visual Analogue Scale (VAS)
2
Description
Behavior of the child
Timepoint
Immediately after injection
Method of measurement
Using the Sound, Eye, Motion Scale (SEM) scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Put ice on the injection site for one minute
Category
Treatment - Other
2
Description
Control group: Apply benzocaine gel to the injection site for one minute
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry in Hamadan city
Full name of responsible person
Zamanian Mohammad Amin
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
aminzamani96@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Zamanian Mohammad Amin
Position
Dentistry Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
aminzamani96@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mahdi Saharkhizan
Position
Pediatric Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mhdsaharkhiz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available