Protocol summary

Study aim
Comparison of efficacy of Pre-Cooling and Topical Anesthetic Gel on the pain perception of Children during palatal injection
Design
This study is based on community-based and pragmatic, split-based, double-blind clinical trials. The number of samples in each group is 14 and in total 28 samples. Each half-jaw is randomly assigned to the case group (cold) and control (gel). The pain intensity of the injections is evaluated by Mann-U-Whitney test in two methods.
Settings and conduct
Injection and dental work of both sides are done at a meeting in Pediatric department of dental school, Islamic Azad University of Tehran. After drying the tissue with cotton on one side, 20% benzocaine gel and the other side of the ice were used for 1 minute each. Anesthesia is performed by the first practitioner (pediatric dentist) using 2% Lidocaine anesthetic and Epinephrine 1/100,000 manufactured by Iran Daroopakhsh with a 30 gauge needle and 16 mm of length. The second operator, which is blind to the group of the study, will examine the child's behavior during an injection with SEM scale (sound, eye and motor). At the end of each of the injections, the child is asked to rate the amount of pain felt on the Wange-Baker scale.
Participants/Inclusion and exclusion criteria
No history of systemic diseases, phobias from injections, allergies to anesthetic substance, abscess and child be cooperative (Frankel's grade 1 or 2 ) and the need for bilateral palatal injection for routine dentistry such as extraction, dental preparation for SSC and wearing rubberdam for pulpotomy and pulpectomy.
Intervention groups
Intervention group: Use of ice that will be prepared by emptying the lidocaine cartridge and filling it with water and placing it in freezer. Control group: use of prime gel (20% benzoycane gel) manufactured by the prime dental company of America.
Main outcome variables
The rate of pain caused by injection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180519039722N1
Registration date: 2018-07-08, 1397/04/17
Registration timing: registered_while_recruiting

Last update: 2018-07-08, 1397/04/17
Update count: 0
Registration date
2018-07-08, 1397/04/17
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
2018-06-13, 1397/03/23
Expected recruitment end date
2018-07-14, 1397/04/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of Pre-Cooling and Topical Anesthetic Gel on the pain perception of pediatric patients during palatal injection
Public title
Effect of pre-cooling injection site on pain perception
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 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
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 28
More than 1 sample in each individual
Number of samples in each individual: 2
In each person, the two half-jaws are randomly assigned to the case (cold) and control (gel) groups. Injection in cold group after using ice cream and in control group after using benzocaine gel 20%, each for 1 minute, with lidocaine 2% anesthesia and epinephrine 1 / 100,000 with needle with 30 gauge length 16 mm will be performed by the same operator.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
It should be noted that the samples are divided into two groups, in half of them, the first injection after the use of the topical anesthetic gel and the second injection after pre-cooling, and in the second group, vice versa. The anesthetic injection is performed by the first practitioner (pediatric dentist) who is only aware of the treatment group of the study. Then, second actors (pediatric dentistry and dentistry student) who are blind to the surface anesthesia selected during the study, will examine the child's behavior when injected with SEM scale (sound, eye and motor). And match the resulting data. At the end of each of the injections, the child is asked to rate the amount of pain felt on the Wonge-Baker scale.
Placebo
Not 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. 4, Tenth Neyestan, Pasdaran Ave, Tehran
City
Tehran
Province
Tehran
Postal code
19585/175
Approval date
2018-04-22, 1397/02/02
Ethics committee reference number
IR.IAU.DENTAL.REC.1397,7

Health conditions studied

1

Description of health condition studied
Correlation of Pre-Cooling and Topical Anesthetic Gel on the pain perception of pediatric patients during palatal injection
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determination of pain induced by injection in the case and control groups by the Wonge-Baker Faces pain rating scale
Timepoint
At the end of each of the injections, the child is asked to rate the amount of pain felt on the Wonge-Baker scale
Method of measurement
Image of Wonge-Baker Faces Pain Rating Scale

2

Description
Determination of pain induced by injection in the case and control groups by Sound-Eye-Motor behavioral evaluation scale
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
Control group: In half of the specimens, the injection is made after placing the impregnated cotton gel, prime gel (Banzocaine 20%) of the prime Dental Company of the United States for 1 minute in the anesthetic region.
Category
Treatment - Drugs

2

Description
Intervention group: In half of the samples, freezing of the carpool (which will be prepared by emptying the lidocaine cartridge and filling it with water and placing it in the freezer), will be used for 1 minute before injection.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatrics section of Dental Branch of Tehran Islamic Azad University
Full name of responsible person
Soha JafarTehrani
Street address
No. 4, Tenth Neyestan, Pasdaran Ave, Tehran
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2294 8466
Email
Soha_j.tehrani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saba Aghaee
Street address
No. 4, Tenth Neyestan, Pasdaran Ave, Tehran
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2276 3459
Email
s_aghaei@dentaliau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Soha JafarTehrani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.12, Third Morvarid Ave, Panahi nia Ave, Heravi Square, Tehran
City
Tehran
Province
Tehran
Postal code
1666815814
Phone
+98 21 2294 8466
Email
Soha_j.tehrani@yahoo.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.4 ,Tenth Neyestan Ave, Pasdaran Ave, Tehran
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2276 3459
Fax
Email
s_aghaei@dentaliau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Soha JafarTehrani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.12, Third Morvarid Ave, Panahi nia Ave, Heravi Square, Tehran
City
Tehran
Province
Tehran
Postal code
1666815814
Phone
+98 21 2294 8466
Email
Soha_j.tehrani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Will be announced at the end of the study.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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