Protocol summary

Summary
The aim of this study is comparison the efficacy of articaine and lidocaine in controlling pain in the maxillary second primary molar in need of pulp therapy. Patients included in this study were patients with second maxillary molar in need of pulp therapy;no history of infection, abscess and fistula in the tooth;no radio graphic sign of intensive internal and external resorption and exclusion criteria were lacking cooperation and teeth with necrotic pulp. The target population is going to be patients attending Pediatric Dentistry Department of Tabriz Faculty of Dentistry at summer and autumn 2014 with maxillary second primary molars in need of pulp therapy, 56 primary maxillary second molar teeth are going to be randomly allocated into two groups. Teeth in group Ι as a control group will get lidocaine as local anesthesia by posterior superior alveolar nerve block and the second group will get infiltration injection with articaine. After 10 min the caries will be removed and if exposed the clinician will ask patient about the presence or absence of pain.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014122920480N1
Registration date: 2015-01-23, 1393/11/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-23, 1393/11/03
Registrant information
Name
Ensiyeh Maljaei
Name of organization / entity
Faculty of Dentistry, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
maljaeie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Science
Expected recruitment start date
2014-12-18, 1393/09/27
Expected recruitment end date
2015-02-16, 1393/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Articain 4% and Lidocaine 2% local anesthesia in the maxillary second primary molar in need of pulp therapy.
Public title
Comparison of the efficacy of Articain 4% and Lidocaine 2% local anesthesia in the maxillary second primary molar in need of pulp therapy.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:patient with second maxillary molar in need of pulp therapy;no history of infection, abscess and fistula in the tooth; children in range of 6-9 (mixed dentition) years of age; no radio graphic sign of intensive internal and external resorption; consent forms filled by parents; patients with no systemic problems; patients cooperation in 3 or 4 frankle group; crown must be restorable after pulp treatment. exclusion criteria: patients lacking cooperation; teeth with necrotic pulp.
Age
From 6 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Postal code
5166614713
Approval date
2014-12-17, 1393/09/26
Ethics committee reference number
93134

Health conditions studied

1

Description of health condition studied
pulpitis
ICD-10 code
K04.0
ICD-10 code description
NOS-acute-chronic (hyperplastic)(ulcerative)-irreversible- reversible

Primary outcomes

1

Description
Pain
Timepoint
10 min after injection
Method of measurement
interview

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients receive a 1 ml buccal infiltration, 4 percent with 1/100000 epinephrin injection by researcher.
Category
Treatment - Drugs

2

Description
Control group: patients receive a 1 ml block (PSA)anesthesia lidocaine 2 percent with 1/80000 epinephrin injection by researcher.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry,Tabriz University of Medical Science
Full name of responsible person
Ensiyeh Maljaei
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
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 of Tabriz 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
Faculty of Dentistry, Tabriz
Full name of responsible person
Raana Ranjbar Hosseinpour
Position
Student
Other areas of specialty/work
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Postal code
5166614713
Phone
+98 41 3335 5956
Fax
+98 41 3334 5977
Email
dr_ranjbar2012@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Dentistry, Tabriz University of Medical Science
Full name of responsible person
Dr.Ensiyeh Maljaei
Position
Assistant professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Postal code
5166614713
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
e_maljaei@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Dentistry, Tabriz
Full name of responsible person
Dr.Ensiyeh Maljaei
Position
Assistant Professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Postal code
5166614713
Phone
+98 914 313 3029
Fax
+98 41 3334 6977
Email
e_maljaei@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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