Protocol summary

Study aim
Comparison of pain caused by palatal injection after using topical anesthetic gel, pre cooling, Vaseline and without any intervention
Design
Patients aged 7 to10 years who need to palatal injection of maxillary primary molar will be randomly selected and divided into 4 groups. In the group of topical anesthesia gel, injection after drying the tissue and placing benzoicin 20% gel for 1 minute, in pre cooling group, after drying and placing the ice carpool for 1minute. And in the placebo group, placing the Vaseline-impregnated ear cleaner for 1 minute, In the last injection group, no intervention will be performed. The injection will be given for 10 seconds, at a rate of 0.2 ml, at a distance of 5 mm from the free edge of the dental gums in the middle of the tooth by the same operator.SEM and Wong Baker Faces will be measured and recorded
Settings and conduct
Children 7to10 years old referring to the pediatrics department ofIslamic Azad University of Medical Sciences, Tehran2020, who need topalatal injection of maxillary primary teeth, randomly divided into 4 groups of 20% topical anesthetic gel, ice carpool, Vaseline befor injection
Participants/Inclusion and exclusion criteria
Inclusion:Co-operative children,Requiring bilateral palatal injection for routine dental work such as extraction, dental preparation,pulpotomy and pulpectomy exclusion:History of systemic diseases,Allergy to dental anesthesia Any phobias from injections and dental work,Having abscess and toothache at the injection site
Intervention groups
In the first group: injection after tissue drying and use20% benzocaine gel for1 min,the second group by placing ice carpool for 1minute,in third group by placing Vaseline-impregnated ear cleaner in place for1 min,and in the fourth group, injections will be performed without any intervention
Main outcome variables
The rate of pain caused by injection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180519039722N3
Registration date: 2020-06-11, 1399/03/22
Registration timing: registered_while_recruiting

Last update: 2020-06-11, 1399/03/22
Update count: 0
Registration date
2020-06-11, 1399/03/22
Registrant information
Name
Saba Aghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2276 3459
Email address
s_aghaei@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2020-12-10, 1399/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of pre-cooling , topical anesthesia gel and placebo on the pain of palatal injection in children
Public title
Evaluation the effect of pre cooling , topical anesthesia gel on the pain of palatal injection in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Co-operative children (Frankl's rating scales III and IV) Requiring bilateral palatal injection for routine dental work such as extraction, dental preparation for stainless steel crown (SSC), pulpotomy and pulpectomy
Exclusion criteria:
History of systemic diseases Allergy to dental anesthesia Any phobias from injections and dental work Having abscess and toothache at the injection site
Age
From 7 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly divided into 4 groups using Balanced block randomization using quadratic blocks using Randomization software.(Balanced block randomization)
Blinding (investigator's opinion)
Single blinded
Blinding description
Anesthesia will be injected by the first surgeon (pediatric dentist) using an anesthetic. The second practitioner, who is blind to the selected topical anesthetic and has been present since the start of the injection, will examine the child's behavior during the SEM (sound, eye, and motor) scale. At the end of each injection, the child is asked to rate the amount of pain felt by selecting a face based on the Wong-Baker Faces scale.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran Islamic Azad University of Dental Branch of Medical Sciences
Street address
No.9, Ninth Neyestan, Pasdaran Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-02-01, 1398/11/12
Ethics committee reference number
IR.IAU.DENTAL.REC.1398.067

Health conditions studied

1

Description of health condition studied
Evaluation the effect of pre-cooling , topical anesthesia gel and placebo on the pain of palatal injection in children
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determination of pain
Timepoint
Immediately after the end of each injection, the child is asked to rate the amount of pain felt
Method of measurement
Image of Wonge-Baker Faces Pain Rating Scale

2

Description
Determination of pain
Timepoint
The pediatric dentist during the injection will examine the child's behavior with the SEM scale (sound, eyes and motion)
Method of measurement
Sound-Eye-Motor behavioral evaluation scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the topical anesthesia gel group, the injection will be performed for 1 minute after drying the tissue with a cotton swab and applying ear cleaner impregnated with 20% prime gel of benzocaine 20% topical anesthesia gel
Category
Treatment - Drugs

2

Description
Intervention group: Injection in the pre cooling group, after drying the tissue with cotton and placing ice carpool for 1 minute (to prepare the ice packs, lidocaine cartridges are emptied and filled with water and then placed in the freezer Took)
Category
Treatment - Other

3

Description
Intervention group: In the placebo group, after drying the tissue with a cotton swab and placing a vaseline for 1 minute at the injection site.
Category
Placebo

4

Description
Control group: The injection will be given alone and without any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatrics section of Dental Branch of Tehran Islamic Azad University
Full name of responsible person
Saba Aghaei
Street address
No.9, Ninth Neyestan, Pasdaran Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
s_aghaei@dentaliau.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saba Aghaei
Street address
No.9, Ninth Neyestan, Pasdaran Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
s_aghaei@dentaliau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Taban Ahadi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No73,Habibnezhad Ave,Estakhr Ave,Tehranpars,Tehran
City
Tehran
Province
Tehran
Postal code
1656945812
Phone
+98 21 7734 4758
Email
tabanahadi96@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saba Aghaei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9, Ninth Neyestan, Pasdaran Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
s_aghaei@dentaliau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Taban Ahadi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No73,Habibnezjad Ave,Estakhr Ave,Tehranpars,Tehran
City
Tehran
Province
Tehran
Postal code
1656945812
Phone
+98 21 7734 4758
Email
tabanahadi96@gmail.com

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
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