Evaluation of effectiveness of using "external cold and vibration" in contrast with control group on amount of pain caused by infiltration injection in 6-12 years old children: randomized clinical trial
Evaluation of effectiveness of using external cold and vibration in contrast with topical anesthesia in amount of pain perceived by children aged between 6-12 years during infiltration technique injection
Design
A randomized, double-blind clinical trial, with control group
Settings and conduct
This study will be held in faculty of dentistry, Isfahan university of medical sciences.
The child's mouth is divided into two parts and it is randomly determined to use vibration and cold on one side and topical anesthesia gel on the other side.
Participants will not know whether they participate in case or control group. Participants will then be assigned with identifiers, generated with an online number generator software, therefor outcome assessors and the manuscript writers will be blind to the identity of participants in both case and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria for this study are children aged 6-12 years who refer to special clinics of the School of Dentistry of Isfahan University of Medical Sciences and need deep restoration of D or E teeth on both sides of the maxilla and want to participate in the study.
Intervention groups
The child's mouth is divided into two parts (split mouth) and it is randomly determined to use vibration and cold on one side and on the other side only anesthetic gel.
Main outcome variables
Pulse rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111219008458N3
Registration date:2021-08-03, 1400/05/12
Registration timing:prospective
Last update:2021-08-03, 1400/05/12
Update count:0
Registration date
2021-08-03, 1400/05/12
Registrant information
Name
Sanaz Ziaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3663 0106
Email address
ziaei@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-20, 1400/05/29
Expected recruitment end date
2021-10-21, 1400/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of using "external cold and vibration" in contrast with control group on amount of pain caused by infiltration injection in 6-12 years old children: randomized clinical trial
Public title
Effect of "External Cold and Vibration" on Maxilla Infiltration injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children referred to the School of Dentistry of Isfahan University of Medical Sciences
Be mentally and physically healthy
They do not take analgesics or sedatives
Be positive or completely positive in terms of Frankl division
Have no previous dental history
Do not have toothache when referred
Need deep restoration of D or E teeth on both sides of the maxilla
Willing to participate in the study
Exclusion criteria:
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Apply external cold and vibration during injection in one side of the mouth and apply topical anesthetic gel for the other side
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random Sampling:
Simple randomization using google's online coin flipper. First, each group will be assigned to a coin flip result. Thereafter, a coin flip will be performed using google's online coin flipper, for each individual, and it will be decided whether the participant is in the Case or Control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will not know whether they participate in case or control group. Participants will then be assigned with identifiers, generated with an online number generator software (numbergenerator.org). Therefor, the putcome assessors, and the manuscript writers will be blind to the identity of participants in both Case and Control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.835
Health conditions studied
1
Description of health condition studied
Pain When Injecting Maxillary Infiltration
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Heart rate during infiltration injection on maxillary teeth
Timepoint
5 minutes before injection, during injection, 5 minutes after injection
Method of measurement
Pulse Oxymeter
Secondary outcomes
empty
Intervention groups
1
Description
Hold the Buzzy(external cold and vibration) on the mucosa of the injection site for two minutes and inject the anesthetic (1.8 ml 2% lidocaine with 1: 100000 epinephrine using a 27 gauge and short needle).The device should be in place while injecting
Category
Treatment - Devices
2
Description
Control group: Benzocaine 20% Dentotix (North Carolina) topical anesthetic gel is applied and injected for 30 seconds.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzal dental clinic
Full name of responsible person
Sanaz Ziaei
Street address
Sorush st.، Ahmadabaad SQ.
City
Isfahan
Province
Isfehan
Postal code
8199616331
Phone
+98 31 3228 4081
Email
sanaz20_2005@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sanaz Ziaei
Street address
Isfahan Dental School, Hezar jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8157895561
Phone
+98 31 3792 5539
Fax
Email
sanaz20_2005@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Sanaz Ziaei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8164986744
Phone
+98 31 3663 0106
Email
sanaz20_2005@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sanaz Ziaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8157895561
Phone
+98 31 3792 3120
Email
sanaz20_2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sanaz Ziaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8157895561
Phone
+98 31 3792 3120
Email
sanaz20_2005@yahoo.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
Yes - There is a plan to make this available
Title and more details about the data/document
Evaluation of external cold and vibration in contrast with topical anesthesia gel in amount of pain perceived by children during infiltration injection
When the data will become available and for how long
Not decided
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Not decided
From where data/document is obtainable
Not decided
What processes are involved for a request to access data/document