Comparing the efficacy of infiltration with 4% articaine and 2% lidocaine for extraction of maxillary primary molars
Design
cross-over, double blinded, randomized clinical trials
randomization is performed by block randomization method.
Settings and conduct
In this study, clinician who collects data and the child will be blinded to the anesthetic solution. In order to inject local anesthesia, the area is first dried by sterilized gauze and then the topical anesthetic gel containing benzocaine will be placed at the injection site for 1 minute. Then, for the buccal infiltration of one side, 1.5 ml of cartridge containing 2% lidocaine and 1:80000 epinephrine and for the other side (in the next session, 1 week later) 4% articaine and 1:100000 epinephrine will be used. The rest of the cartridge will be injected 2 mm above the lingual margin. 3 minutes after injection of both anesthesia, the sense of soft tissue is examined by the explorer in the buccal and lingual gingiva. Maximum waiting for anesthesia is 5 minutes. If soft tissue is not anesthetized, it is considered as a failure in the anesthesia and the tooth will be excluded from the study. After obtaining soft tissue anesthesia, the tooth will be loosed by elevator and in absence of complete anesthesia during luxation, the tooth will be excluded from the study. In order to evaluate the efficacy of anesthetic substance, we utilize facial analogue scale and after extraction, we show the scale to the child and he will mention the smiley most resemble his pain. It should be mentioned that informed consent will be obtained from parents before treatment procedure.
Participants/Inclusion and exclusion criteria
6 to 9 year old cooperative children needing 2 primary molars extraction
Intervention groups
intervention I: infiltration with 2% lidocaine
intervention II: infiltration with 4% articaine
Main outcome variables
pain during extraction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161029030552N2
Registration date:2018-12-24, 1397/10/03
Registration timing:retrospective
Last update:2018-12-24, 1397/10/03
Update count:0
Registration date
2018-12-24, 1397/10/03
Registrant information
Name
yasamin khaksar
Name of organization / entity
shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 8091
Email address
khaksar_y@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2018-12-06, 1397/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of infiltration with 4% articaine and 2% lidocaine for extraction of maxillary primary molars
Public title
comparing the pain during extraction of maxillary primary molars after injection with articaine and lidocaine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
at least 2 maxillary primary molars with same characteristics needing extraction
cooperative behavior for dental treatment under local anesthesia
physical and psychological health of the child
Exclusion criteria:
history of allergy to local anesthetic solution
abscess in the injection site
consumption of analgesics in the last 24 hours
Age
From 6 years old to 9 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
44
More than 1 sample in each individual
Number of samples in each individual:
2
2 maxillary primary molars
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization has been used. block size is 4 and a total number of 11 blocks is created.
Blinding (investigator's opinion)
Double blinded
Blinding description
as both injections use same method, the child is blinded to the treatment.
the investigator help the child to scale the pain, enters the operation room after injection and is blinded to the local anesthetic agent.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shiraz university of medical sciences
Street address
Karim khan zand Ave.,Central building of shiraz university of medical sciences
City
shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-12-19, 1397/09/28
Ethics committee reference number
IR.SUMS.REC.1397.802
Health conditions studied
1
Description of health condition studied
local anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
pain
Timepoint
during tooth extraction
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: infiltration with a carpule 2% lidocaine and 1.80000 epinephrine
Category
Prevention
2
Description
Intervention group: infiltration with a carpule containing 4% articaine and 1.100000 epinephrine
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
private dental clinic
Full name of responsible person
Dr. Soleiman Fijan
Street address
Rahmatabad Ave., Pras complex
City
Shiraz
Province
Fars
Postal code
71346-153888
Phone
+98 71 3627 6615
Email
dr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Zand Ave
City
Shiraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3212 2389
Email
khaksar_y@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Yasamin Khaksar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental Faculty, Qomabad Ave.
City
Shiraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3626 3193
Email
khaksar_y@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yasamin Khaksar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz dental faculty,Qomabad Ave.Shiraz
City
Shiraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3626 3193
Email
Khaksar_y@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yasamin Khaksar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz dental faculty,Qomabad Ave.Shiraz
City
Shiraz
Province
Fars
Postal code
7195944315
Phone
+98 71 3626 3193
Email
Khaksar_y@sums.ac.ir
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
Yes - There is 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
Demographic data and the result of statistical analysis of the clinical trial
When the data will become available and for how long
1year later
To whom data/document is available
Researchers
Under which criteria data/document could be used
after publication of the article
From where data/document is obtainable
sending Email to the researchers
What processes are involved for a request to access data/document