Comparison of the effect of 4% Articaine Buccal Infiltration and 2% Lidocaine Inferior Alveolar Nerve Block on Pain Perception and Behavioral Feedback of Children during Pulp Treatment of mandibular second primary molars
Comparison of articaine buccal infiltration and lidocaine inferior alveolar nerve block for pulpotomy of second primary mandibular molars
Design
4-6 years old children who are healthy and have good coopration and need bilateral mandibular second primary molar pulp therapy
Settings and conduct
This clinical trial study on prevention of decay progress, will be done in Tabriz Dentistry Faculty. The samples will be 38 individuals in the age group of 4-6 years. After obtaining informed consent from patient's parents, in each treatment session, one method will be used in one side of the mouth.
For evaluation of child's pain and behavior during injection and treatment, Face Scale and Visual Analogue Scale will be used respectively.
Participants/Inclusion and exclusion criteria
Major Inclusion and Exclusion criteria: 4-6 years old subject; Children that in pre-study visit according to frankle scale for behaviors classified as Class 3 or 4 and consider as cooperative; Two mandibular primary second molars that needs pulpotomy treatment; subjects did not satisfy the inclusion criteria; History of spontaneous or nocturnal pain; gingival abscess or sinus tract will be excluded from study.
Intervention groups
Intervention: intervention group infiltration injection, with one 1.8 ml cartridge of 4% articaine with 1: 100000 epinephrine
Control group: inferior alveolar nerve block, with one 1.8 ml of 2% lidocaine with 1: 80000 epinephrine
Main outcome measures: Pain during pulpotomy treatment
Main outcome variables
Pain during pulpotomy treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100125003168N5
Registration date:2018-02-07, 1396/11/18
Registration timing:retrospective
Last update:2018-02-07, 1396/11/18
Update count:0
Registration date
2018-02-07, 1396/11/18
Registrant information
Name
Leila Erfanparast
Name of organization / entity
Tabriz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
erfanparastl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-01-24, 1396/11/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of 4% Articaine Buccal Infiltration and 2% Lidocaine Inferior Alveolar Nerve Block on Pain Perception and Behavioral Feedback of Children during Pulp Treatment of mandibular second primary molars
Public title
Articaine efficacy in primary second molar anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
4-6 year old children, attending to Department of Pediatric Dentistry of Tabriz University of Medical Sciences
Children who are 3 or 4 frankle in terms of cooperation
No history of allergic reaction to local anethesia
No systemic disease that don not let the dentist treat under local anesthesia
No pain killer taken for at least 24 hour before treatment
Two mandibular primary second molars that needs pulpotomy treatment
patient collaboration and acceptance of treatment
Exclusion criteria:
History of spontaneous or nocturnal pain
Gingival abscess or sinus tract
Furcation radiolucency
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
More than 1 sample in each individual
Number of samples in each individual:
2
Two mandibular second primary molars are one on one side and the other on the other side that need pulp therapy.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups of 2 and 1.
At the first meeting, for all patients in group 1, infiltration is performed on the second right molar, and in the next session of the treatment, the block method will be performed on the opposite side.
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
Research vice-chancellor,Tabriz University of Medical Sciences
Street address
Daneshgah Ave. - Golgasht St.-Tabriz University of Medical Scienc
Intervention 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 - Drugs
2
Description
Control group: Inferior alveolar nerve block method will be applied with 2% lidocaine solution with 1:80000 epinephrine (Persocaine® Darou Pakhsh Co-tehran, Iran). 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
Tabriz Faculty of Dentistry-Department of Pediatric Dentistry
Full name of responsible person
Leila Erfanparast
Street address
Daneshgah Ave- Golgasht St.-Tabriz Univdrsity of Medical Sciences-Faculty of Dentistry-Department of Pediatric Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
Erfanparastl@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Reasearch Vice-Chancellor- Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Daneshgah Ave- Golgasht St.- Main Buliding-3rd floor
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 4333 0310
Fax
+98 41 3334 6977
Email
Erfanparastl@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reasearch Vice-Chancellor- Tabriz 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
Faculty of Dentistry
Full name of responsible person
Leila Erfanparast
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah Ave-Golgasht St.- Faculty of Dentistry-Department of Pediatric Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
Erfanparastl@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry
Full name of responsible person
Leila Erfanparast
Position
Associate Professore
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah Ave-Golgasht St-Tabriz University of Medical Sciences-Faculty of Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
Eranparastl@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Dentistry
Full name of responsible person
Leila Erfanparast
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshgah Ave-Golgasht St-Tabriz University of Medical Sciences-Faculty of Dentistry
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
Erfanparastl@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.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