Purpose:Comparison of Effectiveness and Pain Perception of Articain and Lidocain due to Dental Second Molar Infiltration in Children Design: Randomized Clinical Trial Population: Children Referred to Pediatric Department of Zahedan Dental School Inclusion Criteria: Healthy 5-7 Years Old Children Who Need Bilateral Buccal Infiltration in Second Primary Molar Exclusion Criteria: Mentally Retarded Children Sample Size: 2 Groups of 20 Subjects Intervention: Evaluating the Effect of Articaine on Efficacy and Pain Perception during Intra Oral Injection Time: During Anesthetic Injection: Reducing the Pain of Intra Oral Injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110213218N3
Registration date:2014-11-13, 1393/08/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-11-13, 1393/08/22
Registrant information
Name
Elham Hosseini
Name of organization / entity
Zahedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 937 203 9978
Email address
drelhamhosseini@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pardis Chabahar, International Unit
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness and Pain Perception of Articain and Lidocain during Dental Second Molar Infiltration in 5-7 Years Old Childeren
Public title
Effect of Articaine on the Efficacy and Pain of Intraoral Anesthetic Injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Healthy 5-7 years old children who need Bilateral Buccal Infiltration Injection in Second Primary Molar and those who will be in cooperative group (Frankle 3-4). Exclusion Criteria: Children with Systemic Disease, Mental Retardation, History of dental treatment, Sensitivity to anesthetics, Taking medications that affect pain.
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Science
Street address
Zahedan University of Medical Science, Dr. Hesabi Square Zahedan Sistan va Baluchestan Iran
City
zahedan
Postal code
9817699693
Approval date
2014-10-04, 1393/07/12
Ethics committee reference number
6819
Health conditions studied
1
Description of health condition studied
Effectivness and Pain Iintensity during Iintraoral Anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Effectivness
Timepoint
during treatment
Method of measurement
SEM Scale
Secondary outcomes
1
Description
Pain Intensity
Timepoint
during injection
Method of measurement
SEM Scale
Intervention groups
1
Description
Lidocain 2% with 1/80000 epinephrine, one dose, 1.8 ml for infiltration annesthesia
Category
Treatment - Drugs
2
Description
Articaine4%, one dose, with epinephrine 1/100000, for block or infiltration anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Department, Zahedan Dental School
Full name of responsible person
Zahra Jami
Street address
Dental School, East Azadegan street
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pardis Chabahar International Unite
Full name of responsible person
Dr. Hamid Reza Mahmoodzade Sagheb
Street address
Zahedan University of Medical Dr. Hesabi Square
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pardis Chabahar International Unite
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
Zahedan University of Medical Science
Full name of responsible person
Zahra Jami
Position
Dental Student
Other areas of specialty/work
Street address
Dental School, East Azadegan street
City
Zahedan
Postal code
Phone
+98 54 1232 4013
Fax
Email
zjami92@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Elham Hosseini
Position
Assistant Proffesor Specialist in Pediatric Dentistry
Other areas of specialty/work
Street address
Dental school, East Azadegan street
City
Zahedan
Postal code
Phone
+98 54 1321 1081
Fax
Email
drelhamhosseini@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Zahra Jami
Position
Dental Student
Other areas of specialty/work
Street address
East Azadegan street
City
Zahedan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)