This randomized clinical trial, single-blind, parallel study is done to compare the effectiveness of Lidocaine block and Articaine infiltration in the pulpal treatment of mandibular second primary molar teeth. 40 Children ranging from 6-10 years of age with no history of systemic diseases, allergic reactions and second primary molars without necrosis who were referred to department of pediatrics, College of Dentistry, Yazd, Iran were selected. Children were randomly divided into two groups of Articaine and Lidocaine and after Articaine infiltration or Lidocaine block injection in two separate sessions, vital pulp therapy treatment for second primary mandibular molar was performed. Vital signs and O2 saturation of children were recorded before after injection. Immediately after the treatment session, patient's level of pain was recorded using visual analogue pain scale of five.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061517935N4
Registration date:2016-05-06, 1395/02/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-06, 1395/02/17
Registrant information
Name
Zahra Bahrololoomi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences-Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 0691
Email address
zbahrololoom@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences of Yazd
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of infiltration of Articaine and block of Lidocaine on pulp therapy of mandibular second primary molar teeth
Public title
Comparison of effectiveness of two anestetic drugs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:children ages 6–10;healthy children; no history of hypersensitivity to analgesics;children with no learning disability. Exclusion criteria: uncooperative children ;necrosis teeth.
Age
From 6 years old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences
Street address
Shahid Bahonar Circle,The central building of Shahid Sadoughi University of Medical Sciences, The ethics committee in research, Yazd Iran
City
Yazd
Postal code
Approval date
2015-10-14, 1394/07/22
Ethics committee reference number
IR.SSU.REC.1394.92
Health conditions studied
1
Description of health condition studied
Local anaesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Pain during pulp therapy
Timepoint
Right after pulp therapy
Method of measurement
Five face Visual Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Before treatment, benzocaine 20% topical anesthetic gel will be applied on dried oral mucosa in injection site area with cotton roll for 1 minute. in test group, infiltration method will be used with 1.8 ml 4% articaine solution with epinephrine 1: 100000 (Septocaine® Septodont Co- France). Injection will be done with a standard aspirating dental syringe and 20 mm, 30 gauge injection needle with injection rate of 1 ml/min. maximum application dose for Articaine is 7 mg/kg.
Category
Treatment - Other
2
Description
Control group: Before treatment, benzocaine 20% topical anesthetic gel will be applied on dried oral mucosa in injection site area with cotton roll for 1 minute. Inferior alveolar nerve block method will be applied with 2% lidocaine solution with 1:100000 epinephrine. Injection will be done with a standard aspirating dental syringe and 20 mm, 30 gauge injection needle with injection rate of 1 ml/min. maximum application dose for lidocaine is 4 mg/kg.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Donya Alinejhad
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Fateme Ezoddini Ardakani
Street address
Circle of Bahonar
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences of Yazd
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
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Donya Alinejhad
Position
Postgraduate Student of Pediatric Dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
Phone
+98 35 3726 7525
Fax
Email
donya_alinejhad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Dr. Zahra bahrololoomi
Position
Associate Professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
Phone
+98 35 3625 0344
Fax
Email
zbahrololoom@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Donya Alinejhad
Position
Postgraduate Student of Pediatric Dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, Dahe Fajr Blvd, Yazd
City
Yazd
Postal code
Phone
+98 35 3625 0344
Fax
Email
donya_alinejhad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)