Comparison of pain reduction between lidocaine and articaine for anesthesia of the second primary molar, requiring pulp therapy, a Randomized Clinical Trial.
Objectives: comparison of the pain perception and onset time of anesthesia between lidocaine and articaine for local anesthesia of the maxillary molar.
Double blind Randomized Clinical Trial among 130 subjects admitted to dental clinic of Qazvin University of Medical Sciences.
All subjects will divided into two groups and individuals in each group will received lidocaine or articaine for local anesthesia. Either lidocaine or articaine will be named as A or B and will be placed in a bottle. The drug will be given to another researcher for injection. Injection will be done randomly. Another researcher will measure pain perception during injection using visual analogue pain scale and the onset time of anesthesia in 1 minute intervals until complete anesthesia. All data will be saved for each subject.
Inclusion criteria: volunteers requiring pulp therapy with intact maxillary molar that response to pulp tester; individuals who can use visual analogue pain scale.
Exclusion criteria: patients with periodontal disease; positive history of alcohol consumption; cigarette smoking; drug user; patients who have received antidepressant or steroid analogues drug during the 48 hours before study; pregnant patients; patients with known allergy to lidocaine or epinephrine; peripheral neuropathy, positive history of dental phobia or any damage to teeth.
Interventions included in Infiltrative injection of 4% articaine carpule with epinephrine 1:100000 in the maxillary molar as group of cases, including 65 cases and 2% lidocaine carpule with epinephrine 1:100000 in the maxillary molar as control group, including 65 cases and measuring of pain perception at the time of injection by using visual analogue pain scale and onset time of anesthesia in one-minute intervals until a complete anesthesia.
Primary outcome is onset time of anesthesia and Secondary outcome is Severity of pain during injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062627111N2
Registration date:2016-08-21, 1395/05/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-21, 1395/05/31
Registrant information
Name
Farshid Rayati
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3353 0615
Email address
frayati@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Qazvin University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pain reduction between lidocaine and articaine for anesthesia of the second primary molar, requiring pulp therapy, a Randomized Clinical Trial.
Public title
Comparison of pain reduction between lidocaine and articaine for anesthesia in extraction of molar teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: volunteers requiring pulp therapy with intact maxillary molar that response to pulp tester; individuals who can use visual analogue pain scale.
Exclusion criteria: patients with periodontal disease; positive history of alcohol consumption; cigarette smoking; drug user; patients who have received antidepressant or steroid analogues drug during the 48 hours before study; pregnant patients; patients with known allergy to lidocaine or epinephrine; peripheral neuropathy, positive history of dental phobia or any damage to teeth
Age
From 21 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done by closed envelops method. lidocaine or articaine for local anesthesia. Either lidocaine or articaine will be named as A or B and will be placed in a bottle. The drug will be given to another researcher for injection. Injection will be done randomly.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd.
City
Qazvin
Postal code
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
Ir.QUMS.REC.1394.820
Health conditions studied
1
Description of health condition studied
Local Anasthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
onset time of anesthesia
Timepoint
1 minute intervals
Method of measurement
Patient Self Recall
Secondary outcomes
1
Description
Severity of pain during injection
Timepoint
Immediately after the injection
Method of measurement
Visual analogue pain scale
Intervention groups
1
Description
Infiltrative injection of 4% articaine carpule with epinephrine 1:100000 and measuring of pain perception at the time of injection by using visual analogue pain scale and onset time of anesthesia in one-minute intervals until a complete anesthesia
Category
Treatment - Drugs
2
Description
Infiltrative injection of 2% lidocaine carpule with epinephrine 1:100000 and measuring of pain perception at the time of injection by using visual analogue pain scale in one-minute intervals by using electric pulp test until a complete anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and maxillofacial surgery Unit of Qazvin Dentistry Faculty
Full name of responsible person
Farshid Raity,MD
Street address
Oral and maxillofacial surgery Unit, Dentistry Faculty of Qazvin University of Medical Sciences, Bahonar Blvd.
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Qazvin University of Medical Sciences
Full name of responsible person
Amin Peymani, MD.
Street address
Qazvin University of Medical Sciences, Bahonar Blvd.
City
Qazvin
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, Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Farshid Rayati
Position
Oral and maxillofacial Surgery Specialist
Other areas of specialty/work
Street address
Oral and maxillofacial surgery Unit, Dentistry Faculty of Qazvin University of Medical Sciences, Bahonar Blvd.
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
farshidrayati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farshid Rayati
Position
Oral and maxillofacial Surgery Specialist
Other areas of specialty/work
Street address
Oral and maxillofacial surgery Unit, Dentistry Faculty of Qazvin University of Medical Sciences, Bahonar Blvd.
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
farshidrayati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farshid Rayati
Position
Oral and maxillofacial surgery Specialist
Other areas of specialty/work
Street address
Oral and maxillofacial surgery Unit, Dentistry Faculty of Qazvin University of Medical Sciences, Bahonar Blvd.
City
Qazvin
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)