Effect of gel Benzocaine 18% versus gel Menthol 10% and 5% on local dentistry injection pain in children 3 to 6 years old: a double-blind randomized clinical trial
Objectives: To assess the effect of gel Benzocaine 18% versus gel Menthol 10% and 5% on local dentistry injection pain in children 3 to 6 years old.
Design: a double blind randomized clinical trial.
Setting and conduct: The eligible 3-6 years old children who will refer to Hamadan School of Dentistry during the study period will be enrolled into the trial.
Inclusion criteria: (a) age of 3 to 6 years; (b) the first dentistry local anesthesia injection; (c) require to repair the first or second molar of the maxilla.
Exclusion criteria: (a) restless child; (b) history of previous dentistry injection; (c) contraindication for anesthesia; (d) absence of the first or second molar of the maxilla; (e) havinf systemic, psychological, or mental disorder, (f) presence of oral abscess or lesions.
Intervention: (a) putting gel Menthol 10% on the location of injection for 30 seconds; (b) putting gel Menthol 5% on the location of injection for 30 seconds.
Control: putting gel Benzocaine 18% on the location of injection for 30 seconds.
Primary outcome: measuring the pain severity just after injection using VAS scale.
Secondary outcome: nothing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501189014N53
Registration date:2015-01-21, 1393/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-21, 1393/11/01
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
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-12-30, 1391/10/10
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of gel Benzocaine 18% versus gel Menthol 10% and 5% on local dentistry injection pain in children 3 to 6 years old: a double-blind randomized clinical trial
Public title
Effect of gel Benzocaine 18% versus gel Menthol 10% and 5% on local dentistry injection pain in children 3 to 6 years old
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 3 to 6 years; (b) the first dentistry local anesthesia injection; (c) require to repair the first or second molar of the maxilla.
Exclusion criteria: (a) restless child; (b) history of previous dentistry injection; (c) contraindication for anesthesia; (d) absence of the first or second molar of the maxilla; (e) havinf systemic, psychological, or mental disorder, (f) presence of oral abscess or lesions.
Age
From 3 years old to 6 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: the patients will be randomly allocated to the intervention and control groups using random numbers table.
Blinding: the gels stained with the anesthetic drugs will be put on the location of injection for 30 seconds by a physician. Then, the injection and measuring the pain will be done by another physician. Neither the patients not the second physician will be aware of the type of anesthetic drugs. Therefore, the trial will be run as double blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2012-04-22, 1391/02/03
Ethics committee reference number
D/P/16/35/9/242
Health conditions studied
1
Description of health condition studied
Injection pain
ICD-10 code
R52
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
measuring the pain severity
Timepoint
just after injection
Method of measurement
using VAS scale
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
putting gel Menthol 10% on the location of injection for 30 seconds
Category
Treatment - Drugs
2
Description
putting gel Menthol 5% on the location of injection for 30 seconds
Category
Treatment - Drugs
3
Description
putting gel Benzocaine 18% on the location of injection for 30 seconds
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Roya pahlavani
Street address
School of Dentistry, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Pharmacy
Full name of responsible person
Dr Fatemeh Zeraati
Position
Pharmacologist
Other areas of specialty/work
Street address
School of Pharmacy, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1590
Fax
Email
fatemez415@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Roya Pahlavani
Position
Lecturer
Other areas of specialty/work
Street address
School of Dentistry, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
zoyapah@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)