Determination of the Effect of Injection of Bacterial Infiltration of 4% Articaine and 2% lidocaine Solutions on Palatal tissue Anesthesia in maxillary primery molars extraction
Design
Clinical trial with control group, parallel, randomized, with blinded postoperative care and outcome assessment
Settings and conduct
A total of 44 healthy children were selected from patients that admitted to pediatric dentistry department of Zahedan college of dentistry who needed bilateral extraction of primery maxillary molars. In half of the children, randomly in the first session, lidocaine and in the second session, articaine and in the other half vice versa were used.The objective pain response of the child was recorded by the trained person who was blind to the medicine that used and the subjective response of the pain was recorded by the child himself and after the explanation given by the assistant.
Participants/Inclusion and exclusion criteria
Age netween 6 to 8 years
No systemic disease and mental retardation
No allergy
No history of dentistry treatment
Intervention groups
Use of each studied anesthetics for one side of the patient
In this study, each child is compared with her/his self.
Main outcome variables
Score of objective pain index; Score of subjective pain index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180220038801N1
Registration date:2018-03-10, 1396/12/19
Registration timing:registered_while_recruiting
Last update:2018-03-10, 1396/12/19
Update count:0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Forough Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 1814
Email address
akbariforooghdds@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of palatal anesthetic efficacy of 4% articaine versus 2% lidocaine in buccal infiltration of maxillary first primary molar.
Public title
Comparison of the effect of two different anesthetics on palatal tissue numbness in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Need of bilateral maxillary molars extraction
Patient cooperation
Exclusion criteria:
Systemic disease
Mental retardation
History of previous dentistry treatment
Allergy to Anesthetic medicine
Abcess in location
Age
From 6 years old to 8 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
44
More than 1 sample in each individual
Number of samples in each individual:
2
The primary molar on one side of the patient is randomly selected as the case group and the other side as the control group.
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In each patient, the tooth of the case and control group is selected randomly using the coin.
Blinding (investigator's opinion)
Double blinded
Blinding description
The investigator and his assistant are unaware of the type of anesthesia and the third person will prepare anesthetic Cartridges for injections.
The patient and his parents did not know the type of medicine used to numb any quadrant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
ZaUMS Main campus, Jenat Blvd., Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-01-14, 1396/10/24
Ethics committee reference number
IR.ZAUMS.REC.1396.339
Health conditions studied
1
Description of health condition studied
The amount of pain during tooth extraction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Objective pain index
Timepoint
5 minutes after injection, while palatal gingiva decollation
Method of measurement
SEM scale
2
Description
Subjective pain index
Timepoint
Immediately after treatment
Method of measurement
FPS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Infilltration injection of 2% articaine
Category
Treatment - Drugs
2
Description
Control group: Infilltration injection of 4% lidocaine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan university of medical sciences
Full name of responsible person
Forough Akbari
Street address
College of dentistry , Eastern Azadegan St. , Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Email
Akbariforooghdds@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Nourmohammad Bakhshani
Street address
ZaUMS Main campus, Jenat Blvd., Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3342 5765
Email
nmbakhsha@zdmv.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Nastaran Seyed Samak
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
College of dentistry, Eastern Azadegan st., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5715
Email
Niloofar.qodoosi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Forough Akbari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
College of dentistry , Eastern Azadegan St. Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3329 5715
Email
Akbariforooghdds@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Forough Akbari
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
College of dentistry , Eastern Azadegan St. , Zahedan City
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1814
Fax
Email
akbariforooghdds@zaums.ac.ir
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