to evaluate the effects of 4% articaine with 1:100000 epinephrine and 2% lidocaine with 1:80000 epinephrine on blood pressure after maxillary infiltration technique.
Sari Dental School, involving maxillary infiltration of local anesthetics. participants, operators, and statistician are blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria were class 1 American Society of Anesthesiologists patients aged 18 to 55 years, not taking any medication, no contraindication for administration of epinephrine -containing anesthetics, non-smoker patients, without dental phobia, without excessive pain or swelling on admission, and not being pregnant.
Patients who experienced dental emergencies after injection were excluded from the study.
Intervention groups
lidocaine group: maxillary infiltration of 2% lidocaine with 1:80000 epinephrine
articaine group: maxillary infiltration of 4% articaine with 1:100000 epinephrine
Main outcome variables
systolic and diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200724048188N1
Registration date:2020-07-27, 1399/05/06
Registration timing:prospective
Last update:2020-07-27, 1399/05/06
Update count:0
Registration date
2020-07-27, 1399/05/06
Registrant information
Name
Parisa Soltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5508
Email address
parisa.soltani@live.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-10, 1399/07/19
Expected recruitment end date
2020-12-10, 1399/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of articaine and lidocaine anesthetics on blood pressure after maxillary infiltration technique: a randomized clinical trial
Public title
Effects of articaine and lidocaine anesthetics on blood pressure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
class 1 American Society of Anesthesiologists
aged 18 to 55 years
not taking any medication
no contraindication for administration of epinephrine
non-smoker
patients without dental phobia
without excessive pain or swelling on admission
not being pregnant
Exclusion criteria:
dental emergencies after injection
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned using computer-generated random numbers into two groups (block randomization). We will use random allocation software for this purpose. Random allocation of patient 1 to 102 into two equal groups will be obtained. Patient's number will be assigned based on order of admission (first patient:1, second patient:2, etc.).
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patients and operators are blind to the experimental groups in all stages of the research study. Only one researcher who is present in the surgical room but is unrelated to the experiments and measurements is aware of the experimental group of each patient. After obtaining informed consent, the patients will not know about the group they are in. The researcher who is not blind will prepare the injection syringe based on the random allocation numbers. He will cover the anesthetic cartridge using black tape, so that the operator does not know which drug is being used. The other operator who is measuring blood pressure does not know the patient's group either. The researcher who was not blind will code the experimental groups (1 and 2) so that the statistician is also blind to the experimental groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Valiasr
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2019-06-11, 1398/03/21
Ethics committee reference number
IR.MAZUMS.REC.1398.544
Health conditions studied
1
Description of health condition studied
systolic and diastolic blood pressure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
systolic and diastolic blood pressure
Timepoint
before intervention, 10 minutes after intervention
Method of measurement
sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: posterior maxillary infiltration injection of 1.2 mL of 4% articaine with 1:100000 epinephrine (Exir, Iran)
Category
Other
2
Description
Intervention group: posterior maxillary infiltration injection of 1.2 mL of 2% lidocaine with 1:80000 epinephrine (Darupakhsh, Iran)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Dental School
Full name of responsible person
Amirhossein Moaddabi
Street address
Valiasr
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3335 2725
Email
a.moaddabi2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeidi (Research Chancellor)
Street address
Valiasr
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3335 2725
Email
a.moaddabi2@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Amirhossein Moaddabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Valiasr
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3335 2725
Email
a.moaddabi2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amirhossein Moaddabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Valiasr
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3335 2725
Email
a.moaddabi2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amirhossein Moaddabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Valiasr
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3335 2725
Email
a.moaddabi2@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
none
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available