A clinical trial to compare the effectiveness of buccal infiltration with 2% lidocaine versus 4% articaine in palatal anesthesia for maxillary teeth extraction
To compare the effectiveness of buccal infiltration with 2% lidocaine versus 4% articaine in palatal anesthesia for maxillary teeth extraction
Design
Totally, 300 patients in the Dental Clinic of Mashhad Faculty of Dentistry, Mashhad, Iran are selected in this study. In this double-blind, controlled clinical trial, the patients are assigned into parallel groups using simple random sampling methods.
Settings and conduct
Patients referring to the Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection and participant are blind to group allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged range 16-60 years; requiring maxillary teeth extraction.
Exclusion criteria: Having drug intolerance; pregnant women; having the uncontrolled systemic disease; mental retardation; having oral infections.
Intervention groups
Intervention group I will receive 0.6 mL of 2 % lidocaine with epinephrine 1:100000. Intervention group II will receive 0.6 ml of 4% articaine hydrochloride with epinephrine 1:100000.
Main outcome variables
Evaluation and comparison of the rate of palatal anesthesia in two intervention groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180710040413N1
Registration date:2020-11-15, 1399/08/25
Registration timing:prospective
Last update:2020-11-15, 1399/08/25
Update count:0
Registration date
2020-11-15, 1399/08/25
Registrant information
Name
Ali Mohammadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4722 0338
Email address
mohammadzadeha933@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of buccal infiltration with 2% lidocaine versus 4% articaine in palatal anesthesia for maxillary teeth extraction
Public title
The effectiveness of lidocaine and articaine in palatal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged range 16-60 years
Requiring maxillary teeth extraction
Exclusion criteria:
Having drug intolerance
Pregnant women
Having uncontrolled systemic disease
Mental retardation
Having oral infections
Age
From 16 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Patients referring to Dental Clinic of Mashhad Faculty of Dentistry, randomly base on random number table method and Randomizer.org website assigned two intervention groups. A code was allocated to each of the participants.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients referring to the Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection and participant are blind to group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9188611393
Approval date
2018-03-07, 1396/12/16
Ethics committee reference number
IR.MUMS.SD.REC.1394.311
Health conditions studied
1
Description of health condition studied
Maxillary teeth extraction
ICD-10 code
K08.9
ICD-10 code description
Disorder of teeth and supporting structures, unspecified
Primary outcomes
1
Description
Palatal anesthesia
Timepoint
every 2 minutes over 1 hour after intervention
Method of measurement
Based on the questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group I will receive 0.6 mL of 2 % lidocaine with epinephrine 1:100000.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group II will receive 0.6 ml of 4% articaine hydrochloride with epinephrine 1:100000.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Ali Mohammadzade
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2301
Email
j.m.dental.s@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2301
Email
j.m.dental.s@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Gholami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2301
Email
gholamimh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Gholami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2301
Email
gholamimh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Gholami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2301
Email
gholamimh@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Information on the main outcome or the like can be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working at science centers and universities.
Under which criteria data/document could be used
Our data will be available for scholars working at science centers and universities.
From where data/document is obtainable
Mahdi Gholami provides the data analysis to the applicants via email: gholamimh@mums.ac.ir
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.