Protocol summary

Study aim
Comparison of anesthesia efficiency of local infiltration with articaine 4% and mental nerve block with lidocaine 2% in extraction of mandibular anterior teeth
Design
A clinical trial with parallel, double-blind, randomized, phase 3 groups on 54 patients was used for Excel software randomization.
Settings and conduct
Patients referred to Alborz Dental Clinic in Urmia for extraction of mandibular anterior teeth and interested in participating in this study, will be divided into two groups: lidocaine recipient and articaine recipient. In both groups, the standard injection with a 25 gauge needle with a short length will be performed slowly (1 minute) by a surgeon under the same conditions. Epinephrine 1: 100000 vasoconstrictor (made by Iran Elixir) will be injected for buccal infiltration and 0.3ml (about one-eighth of the cartridge) for lingual infiltration. In the second group, after needle insertion and negative blood aspiration, 1.5 ml of 2% lidocaine anesthetic solution with vasoconstrictor epinephrine 1: 100000 (made by Iran Elixir) by mental block method and 0.3 ml (about one-eighth of the cartridge) ) Will also be injected for lingual infiltration.
Participants/Inclusion and exclusion criteria
Patients with age range of 18-45 At least one mandibular anterior tooth No systemic problems No allergies to anesthetic solutions used Absence of inflammation and soft tissue infection near the injection site Do not take painkillers 24 hours before treatment
Intervention groups
In the first group, 4% articaine anesthetic solution with 1: 100000 epinephrine vasoconstrictor (made by Iran Elixir) and in the second group, 2% lidocaine anesthetic solution with 1: 100000 epinephrine vasoconstrictor (made by Iran Elixir) will be injected.
Main outcome variables
Pain level of patients during surgery based on SEM scale.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220117053751N1
Registration date: 2022-03-30, 1401/01/10
Registration timing: registered_while_recruiting

Last update: 2022-03-30, 1401/01/10
Update count: 0
Registration date
2022-03-30, 1401/01/10
Registrant information
Name
amir soltanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3336 3600
Email address
amirsoltanpour76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Anesthesia Efficiency of Local Infiltration with Articaine 4% and Mental Nerve Block with Lidocaine 2% in Extraction of Mandibular Anterior Teeth
Public title
Evaluation of Anesthesia Efficiency of Local Infiltration with Articaine 4% and Mental Nerve Block with Lidocaine 2% in Extraction of Mandibular Anterior Teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with age range of 18-45 At least one mandibular anterior tooth No systemic problems No allergies to anesthetic solutions used Absence of inflammation and soft tissue infection near the injection site Do not take painkillers 24 hours before treatment
Exclusion criteria:
systemic problems like diabet allergies to anesthetic solutions used inflammation and soft tissue infection near the injection site take painkillers 24 hours before treatment
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups of 27 based on limited randomization and using the law of random allocation. Randomization based on a single sequence of random allocations is called simple or unlimited randomization. Simple randomization is one of the most common methods used to perform the randomization process. In this method, there is a possibility of inequality in the number of people assigned to each group, especially in studies with a small sample size. While according to the probability hypothesis, with increasing the sample size, this inequality will be greatly reduced and the division will be based on the coin toss.
Blinding (investigator's opinion)
Double blinded
Blinding description
Researchers will be blind to the process of randomization and sample allocation. The patient's pain will be assessed by a second person who will be on the blind injection.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of urmia University of Medical Sciences
Street address
Orjans ave,urmia University of Medical Sciences
City
urmia
Province
West Azarbaijan
Postal code
2344675432
Approval date
2021-11-09, 1400/08/18
Ethics committee reference number
IR.UMSU.REC.1400.349

Health conditions studied

1

Description of health condition studied
compare anesthesia drugs
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain
Timepoint
during tooth extraction
Method of measurement
The SEM scale will be used to measure the patient's pain during treatment, which is a ranking variable. The SEM scale for measuring pain is a valid, useful and easy-to-use scale that is used in various researches. This scale includes recording of the patient's voice (Sound), examination of the eyes (Eyes) and patient movements (Motor), which will be recorded separately for each treatment, after the injection.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Anesthetic recipient Local infiltration with 4% articaine with lingual infiltration, standard injection with 25 gauge needle with short length will be done slowly (1 minute) by a surgeon in the same conditions. After the needle is inserted. And negative blood aspiration, 1.5 ml of 4% articaine anesthetic solution with 1: 100000 epinephrine vasoconstrictor (made by Iran Elixir) for buccal infiltration and 0.3 ml (about one-eighth of the cartridge) for lingual infiltration will be injected.
Category
Treatment - Surgery

2

Description
Intervention group 2: After needle insertion and negative blood aspiration, 1.5 ml of 2% lidocaine anesthetic solution with 1: 100000 epinephrine vasoconstrictor (made by Iran Elixir) by mental nerve block method and 0.3 ml (about one-eighth of the cartridge) Will also be injected for lingual infiltration.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Alborz dental clinic
Full name of responsible person
Farhad Nojan
Street address
Alborz st,Alborz dental clinic
City
urmia
Province
West Azarbaijan
Postal code
2345674345
Phone
+98 44 3336 3590
Email
amirsoltanpour76@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Alborz st
City
Urmia
Province
West Azarbaijan
Postal code
2345674345
Phone
+98 44 3336 3590
Email
amirsoltanpour76@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Amir Soltanpour
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Alborz street,alborz dental clinic
City
Urmia
Province
West Azarbaijan
Postal code
2345674345
Phone
+98 44 3336 3600
Fax
Email
amirsoltanpour76@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Amir Soltanpour
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Alborz street,alborz dental clinic
City
Urmia
Province
West Azarbaijan
Postal code
2345674345
Phone
+98 44 3336 3600
Fax
Email
amirsoltanpour76@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Amir Soltanpour
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Alborz street,alborz dental clinic
City
Urmia
Province
West Azarbaijan
Postal code
2345674345
Phone
+98 44 3336 3600
Fax
Email
amirsoltanpour76@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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