The anesthetic effectiveness of mandibular buccal infiltration with articaine compared to mandibular block anesthesia with lidocaine in pulpotomy of second primary molars.
Articaine efficacy in primary second molar anesthesia
Objectives: Comparison of articaine buccal infiltration and lidocaine inferior alveolar nerve block for pulpotomy of second primary mandibular molars.
Design: Controlled clinical trial
Setting and conduct: after achieving 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, Faces Pain Scale and Modified Behavioral Pain Scale will be used respectively.
Major Inclusion and Exclusion criteria:
Intervention: Infiltration method will be used with 1.8 ml 4% articaine solution with epinephrine 1: 100000 in intervention group; Inferior alveolar nerve block method will be used with 2% lidocaine solution with 1: 80000 epinephrine in control group.
Major Inclusion and Exclusion criteria:
5-8 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: 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; child sensation during injection
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042321484N2
Registration date:2015-10-06, 1394/07/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-06, 1394/07/14
Registrant information
Name
Zahra Khosravi
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3824 3014
Email address
zahrakhosrav@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-07-06, 1394/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The anesthetic effectiveness of mandibular buccal infiltration with articaine compared to mandibular block anesthesia with lidocaine in pulpotomy of second primary molars.
Public title
Articaine efficacy in primary second molar anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 5-8 years old subject (Children under 5 years will be excluded from trial because of problem in communication and differentiation between pain and other negative reaction. children older than 8 years will be excluded because of possible physiologic root resorption); Children that consider as cooperative in pre-study visit (According to frankle scale for behaviors classified as Class 3: child is cooperative, but somewhat reluctant/ shy; Class 4: child is completely cooperative and even enjoys the experience); Two mandibular primary second molars that needs pulpotomy treatment; No history of allergic reaction to local anethetics and sulfites; No systemic disease that don not let the dentist treat under local aneshtesia; No pain killer taken for at least 24 hour before treatment.
Exclusion criteria: subjects did not satisfy the inclusion criteria; History of spontaneous or nocturnal pain; gingival abscess or sinus tract; Radiographic sign of PDL widening, reduction in supporting bone density, furcation radiolucency or pathologic root resorption.
Age
From 5 days old to 8 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Not 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
The ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz street.Qods street,The central building of Tehran University of Medical Sciences,6th floor,The ethics committee in research
City
tehran
Postal code
Approval date
2015-08-18, 1394/05/27
Ethics committee reference number
IR.TUMS.REC.1394.610
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 pulpotomy treatment
Timepoint
During intervention
Method of measurement
Modified Taddio’s behavioural pain scale
2
Description
Child sensation during injection
Timepoint
During intervention
Method of measurement
Wong–Baker FACES pain rating scale
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention Group:
Before treatment, benzocaine 20% topical anesthetic gel (Benzotop-DFL.Industria e Comercio) 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 (Benzotop-DFL. Industria e Comercio) 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 1:80000 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
Pediatric Department of Dentistry Faculty-Tehran University of Medical Sciences
Full name of responsible person
Dr.zahra khosravi
Street address
School Of Dentistry Of Tehran University Of Medical Sciences, North Kargar Street, Enghelab Square,
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr. Zahra Khosravi
Street address
Number 218, Fatemi street, North Kargar Street, Enghelab Square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Pediatric department of dentistry faculty-tehran university of medical sciences
Full name of responsible person
Dr.zahra khosravi
Position
Postgraguate student of pediatric dentistry
Other areas of specialty/work
Street address
North kargar Street, after Atomic Energy Organization, school of dentistry
City
tehran
Postal code
Phone
+98 214289404
Fax
Email
zahrakhosrav@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pediatric department of dentistry faculty-tehran university of medical sciences
Full name of responsible person
Dr.zahra khosravi
Position
Postgraguate student of pediatric dentistry
Other areas of specialty/work
Street address
North kargar Street, after Atomic Energy Organization, school of dentistry
City
tehran
Postal code
Phone
+98 214289404
Fax
Email
zahrakhosrav@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pediatric department of dentistry faculty-tehran university of medical sciences
Full name of responsible person
Dr. zahra khosravi
Position
Postgraguate student of pediatric dentistry
Other areas of specialty/work
Street address
North kargar Street, after Atomic Energy Organization, school of dentistry
City
Tehran
Postal code
Phone
+98 214289404
Fax
Email
zahrakhosrav@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)