Comparison of the anesthetic efficacy of Articaine infiltration versus lidocaine inferior alveolar nerve block in pulp therapy of lower second primary molars
Comparison of the effect of articaine infiltrated anesthesia with lidocaine block anesthesia in the treatment of pulpotomy of mandibular second molars
Design
A randomized clinical trial with cross-over groups, double-blind, phase 2-3 on 76 patients
Settings and conduct
In this study, the pain of articaine infiltration and lidocaine infra alveolar nerve block was investigated. Both injections are given to all individuals, the first group's infusion of lidocaine infra alveolar nerve block injection and the second session infusion of articaine infiltration, the first two sessions infusion of articaine infiltration and the second infusion of infra alveolar nerve block infusion of lidocaine to each person using lidocaine. The VAS chart measures the amount of pain before and at the start of the injection. The participant and the VAS reviewer will not be aware of the type of injection.
Participants/Inclusion and exclusion criteria
Healthy children aged four to ten years who need treatment for mandibular pulp on both sides are included in our study. In terms of cooperation in the first session with fluoride therapy and prophylaxis, we place these children in the positive or completely positive category of the Frankel classification, and in the medical history, we check that they have no problem performing anesthesia injections. Children who have any sores or mucosal lesions during treatment sessions at the buccal vestibule or do not return for the second treatment session will be excluded from the study and replaced with another child.
Intervention groups
Group one: The first session of lidocaine infra alveolar nerve block injection and the second session of articaine infiltration injection
Group 2: The first session of articaine infiltration injection and the second session of lidocaine infra alveolar nerve block injection
Main outcome variables
Reduce pain during anesthesia injection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170101031697N5
Registration date:2021-01-07, 1399/10/18
Registration timing:registered_while_recruiting
Last update:2021-01-07, 1399/10/18
Update count:0
Registration date
2021-01-07, 1399/10/18
Registrant information
Name
Afshin Parvizpanah
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 6625
Email address
afshin.parvizpanah@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-26, 1399/10/06
Expected recruitment end date
2021-01-25, 1399/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the anesthetic efficacy of Articaine infiltration versus lidocaine inferior alveolar nerve block in pulp therapy of lower second primary molars
Public title
Comparison of the effect of articaine infiltrated anesthesia with lidocaine block anesthesia in the treatment of mandibular second molar palpotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy children four to ten years old who need treatment for the pulp molars of the mandible on both sides.
Exclusion criteria:
Children who have any sores or mucosal lesions during treatment sessions in the buccal vestibule.
Age
From 4 years old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization of participants as an individual unit and simple randomization, which will be divided into two equal groups based on the random division command in SPSS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: The participant's blindness is such that before injecting anesthesia, the person is asked to open his mouth, at which time the injector waits for a minute and then injects. This causes the patient not to notice the injection.
Impact Assessor: The outcome assessor will not be aware of the type of injection when evaluating the patient.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bandar Abbas University of Medical Sciences
Street address
Ethics Committee of Bandar Abbas University of Medical Sciences,Research Deputy Building, Shahid Mohammadi Hospital, Jomhoori Islami Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2020-12-23, 1399/10/03
Ethics committee reference number
IR.HUMS.REC.1399.462
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
Pain when exposing the pulp
Timepoint
When exposing the pulp
Method of measurement
Using the Visual Analogue Scale chart
2
Description
Pain during injection start
Timepoint
During injection start
Method of measurement
Using the Visual Analogue Scale chart
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the first session of lidocaine infraalveolar nerve block injection and the second session of articaine infiltration injection. In this group, in order to pulpotomy of second primary mandibular molar in one session, after preparing radiography and performing the initial steps for treatment, infra alveolar nerve block injection using carpol lidocaine 2% with epinephrine 1: 100000, for a child at one minute will be done. After the appropriate time (10 minutes) and ensuring complete anesthesia by using the lip anesthesia index, we begin the process of removing the caries and preparing the access cavity, and the child's reaction will be measured at the moment of pulp exposure. Before the test, we explain the VAS (Visual Analogue Scale) diagram and how to show the amount of discomfort on it to the child and immediately ask the child during the cutting of the cavity in the dentin or in cases of pulp treatment at the moment of pulp exposure to mark the appropriate face on the VAS chart, depending on the amount of pain or discomfort. The same child will be treated for the pulpotomy of second primary mandibular molar in opposite side in the next session, one week after the first session. After preparing the radiography and performing the initial steps for treatment, infiltration injection in the vicinity of the target tooth using carpool articaine 4% with epinephrine 1: 100000, will be performed for the child in one minute. After the appropriate time (10 minutes) and ensuring complete anesthesia by using the lip anesthesia index, we begin the process of caries removal and preparation of the access cavity, and the child's reaction will be measured at the moment of pulp exposure. Explain the Visual Analogue Scale and how to display the amount of discomfort on it to the child and immediately when cutting the cavity in the dentin or in cases of need for pulp treatment at the moment of pulp exposure, we ask the child to mark the appropriate face on the VAS chart, depending on the amount of pain or discomfort.
Category
Treatment - Drugs
2
Description
Intervention group: The first session of articaine infiltration injection and the second session of lidocaine infra alveolar nerve block injection. In this group, in order to pulpotomy of second primary mandibular molar in one session, after preparing radiography and performing the initial steps for treatment, infiltration injection in the vicinity of the target tooth using 4% carpool articaine with 1: 100000 epinephrine, for the child It will be done in one minute. After the appropriate time (10 minutes) and ensuring complete anesthesia by using the lip anesthesia index, we begin the process of removing the caries and preparing the access cavity, and the child's reaction will be measured at the moment of pulp exposure. Before the test, we explain the VAS (Visual Analogue Scale) diagram and how to show the amount of discomfort on it to the child and immediately ask the child during the cutting of the cavity in the dentin or in cases of pulp treatment at the moment of pulp exposure to mark the appropriate face on the VAS chart, depending on the amount of pain or discomfort, and the same child will be treated for the opposite side of the mandible in the next session, one week after the first session. After preparing radiography and performing the initial steps for treatment, infra alveolar nerve block injection using carpol lidocaine 2% with epinephrine 1: 100000, for a child at one minute will be done. After the appropriate time (10 minutes) and ensuring complete anesthesia by using the lip anesthesia index, we begin the process of removing the caries and preparing the access cavity, and the child's reaction will be measured at the moment of pulp exposure. Before the test, we explain the VAS (Visual Analogue Scale) diagram and how to show the amount of discomfort on it to the child and immediately ask the child during the cutting of the cavity in the dentin or in cases of pulp treatment at the moment of pulp exposure to mark the appropriate face on the VAS chart, depending on the amount of pain or discomfort.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Bandar Abbas Faculty of Dentistry
Full name of responsible person
Sara Esmaeili
Street address
Dental Clinic of Bandar Abbas School of Dentistry, Shahid Naser St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964153
Phone
+98 76 3335 0458
Email
mail@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teamour Aghamolai
Street address
Shahid Mohammadi Hospital, Jomhouri Islami St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
taghamolaei@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sara Esmaeili
Position
Pediatric dentist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Bandar Abbas School of Dentistry, Shahid Naser St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
saraesmaili43@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sara Esmaeili
Position
Pediatric dentist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Bandar Abbas School of Dentistry, Shahid Naser St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
saraesmaili43@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Sara Bakhshaei
Position
Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Bandar Abbas School of Dentistry, Shahid Naser St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
saraesmaili43@gmail.com
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
Yes - There is 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
The information obtained from this study can be shared without the ability to identify participants.
When the data will become available and for how long
From October 2021
To whom data/document is available
Researchers and referees
Under which criteria data/document could be used
Obtaining a written permit and mentioning the name in the sources and references
From where data/document is obtainable
Sara Bakhshaei
saraesmaili43@gmail.com
What processes are involved for a request to access data/document
The request must first be emailed and answered after review and approval.