Comparison of pain perception and onset time of anesthesia between lidocaeine and articaine for local anesthesia of the maxillary central incisor in healthy subjects: a randomized, double blind crossover trial
The aim of this randomized cross over double blind clinical trial is to compare the pain perception and onset time of anesthesia between lidocaeine and articaine for local anesthesia of the maxillary central incisor. This study will be performed among 16 healthy subjects who come to dental clinic of Hormozgan University of Medical Sciences. Inclusion criteria containing healthy volunteers with intact maxillary central incisor that response to pulp test; individuals who can use visual analogue pain scale.
Exclusion criteria containing 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.
All subjects will divided into two groups and individuals in each group will received lidocaine or articaine for local anesthesia of maxillary central incisor. 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. 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 by electric pulp test. All data will be saved for each subject and after 2 week interval, the intervention will be replace with another option for anesthesia induction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110613932N3
Registration date:2016-06-19, 1395/03/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-19, 1395/03/30
Registrant information
Name
Seyed Shojaeddin Namazi
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1333 4190
Email address
ssh.namazi@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Hormozgan University of Medical Sciences
Expected recruitment start date
2016-02-21, 1394/12/02
Expected recruitment end date
2016-04-21, 1395/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pain perception and onset time of anesthesia between lidocaeine and articaine for local anesthesia of the maxillary central incisor in healthy subjects: a randomized, double blind crossover trial
Public title
comparison of anesthetic effect between lidocaine and articain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: healthy volunteers with intact maxillary central incisor 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
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Hormozgan University of Medical Sciences
Street address
Research Counsil Building, Shahid Mohammadi Hospital, jomhoori Eslami Blvd
City
Bandar Abbas
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
HUMS.REC.1394.86
Health conditions studied
1
Description of health condition studied
local anesthesia
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
Electric Pulp Test
2
Description
Severity of pain during injection
Timepoint
Immediately after the injection
Method of measurement
Visual analogue pain scale
Secondary outcomes
empty
Intervention groups
1
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 and onset time of anesthesia in one-minute intervals by using electric pulp test until a complete anesthesia
Category
Other
2
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 by using electric pulp test until a complete anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
dental clinic of hormozgan university of medical sciences
Full name of responsible person
Rokhsare Zare Shahri
Street address
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Hormozgan University of Medical Sciences
Full name of responsible person
Abdolazim Nejatizadeh
Street address
Research Counsil Building, Shahid Mohammadi Hospital. Jomhoori Eslami Blvd
City
Bandar Abbas
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, Hormozgan 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
Student Research Committee
Full name of responsible person
Rokhsare Zare Shahri
Position
Dental Student
Other areas of specialty/work
Street address
Dental Clinic of Hormozgan University of Medical Sciences, Shariati Hospital, Shahid Naser Blvd