Comparison of two anesthetics methods of Inferior Alveolar Nerve Block and crestal anesthesia and two anesthetics materials of lidocaine and articaine in the crestal anesthesia for pulpotomy treatment of primary molars
Determination and comparison of local anesthesia of inferior alveolar nerve block (IANB) and crystal anesthesia (CA) in the treatment of pulpotomy of mammary molars
Determining and comparing the use of lidocaine and articaine anesthetics in crystal anesthesia (CA) in the treatment of mammary pulpotomy
Design
Clinical trial. With parallel groups. One-way blind. Randomized. Phase 2 on 90 patients.
To randomize the Crossover plan will be done in 2 separate sessions at least one week apart
Settings and conduct
In the pediatric dentistry department, pulpotomy of 2 teeth will be performed during 2 facial sessions in 45 children with block anesthesia and in the post-crystal anesthesia session. In another 45 children, a local anesthesia session will be performed with lidocaine and the next session with articaine.Data analyzer compared to blinded study.
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
1- Children who need a bilateral pulpotomy of deciduous molars (D or E) in the mandible based on clinical signs and radiography and at the diagnosis of a pediatric dentist.
2- Age category 4 to 8 years
3- Parents' consent to partiExclusion criteria include:
1- Having a history of systemic disease
2- Having severe fear and anxiety
3- Using painkillers to control toothache
4- Having acute dental infections
5- Having deciduous molars that have more than two thirds of their roots decayedcipate in the study
Intervention groups
Pulpotomy of 2 teeth will be done in 2 sessions; In 45 children, one session of local anesthesia will be performed on the inferior alveolar nerve block (IANB) and in the other session, crystal anesthesia (CA) will be performed, and in 45 children, one session of local anesthesia will be performed with lidocaine and the next session with articaine.
Main outcome variables
Pain during pulpotomy treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171020036896N9
Registration date:2021-06-05, 1400/03/15
Registration timing:registered_while_recruiting
Last update:2021-06-05, 1400/03/15
Update count:0
Registration date
2021-06-05, 1400/03/15
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32119023
Email address
sajadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-20, 1400/01/31
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two anesthetics methods of Inferior Alveolar Nerve Block and crestal anesthesia and two anesthetics materials of lidocaine and articaine in the crestal anesthesia for pulpotomy treatment of primary molars
Public title
Clinical success and pain of two anesthetics methods of Inferior Alveolar Nerve Block and crestal anesthesia and two anesthetics materials of lidocaine and articaine in the crestal anesthesia for pulpotomy treatment of primary molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children who need a bilateral pulpotomy of deciduous molars (D or E) in the mandible based on clinical signs and radiography and at the diagnosis of a pediatric dentist.
Age category 4 to 8 years
Parents' consent to participate in the study
Exclusion criteria:
Having a history of systemic disease
Having severe fear and anxiety
Using painkillers to control toothache
Having acute dental infections
Having deciduous molars that have more than two thirds of their roots analyzed
Age
From 4 years old to 8 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
2
Pulpotomy of 2 teeth will be done in 2 sessions
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the simple randomization method (flip the coin) will be used. In such a way that one of the study groups will be considered as heads and the other group will be considered as tails. Then the same number of coins will be thrown based on the sample size. Finally, to prevent disclosure of random sequencing, the allocation concealment will be used
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not aware of local anesthetic agent and technique at the time of treatment. Statistics consultant is not aware of local anesthetic agent and technique at the time of treatment too.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
shafa street
City
kerman
Province
Kerman
Postal code
7618759689
Approval date
2021-03-01, 1399/12/11
Ethics committee reference number
IR.KMU.REC.1399.645
Health conditions studied
1
Description of health condition studied
The comparison of effect of inferior alveolar nerve block and crestal local anesthesiain in pulpotomy of primary teeth
ICD-10 code
ICD-10 code description
2
Description of health condition studied
The effect of crestal local anesthesia using lidocaine in pulpotomy of primary teeth
ICD-10 code
ICD-10 code description
3
Description of health condition studied
The effect of crestal local anesthesia using articaine in pulpotomy of primary teeth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
Immediately after the crestal injection, the child's pain is measured by the VAS (Visual Analogue Scale) during the opening of the dental pulp.
Method of measurement
The child's pain is measured by the VAS (Visual Analogue Scale).
2
Description
Changes in the heart rate to determine the amount of pain experienced by the child during the crestal injection.
Timepoint
Changes in a child's heart rate are made by using a pulse oximeter 5 seconds before and immediately after the local anesthetic injection.
Method of measurement
Changes in a child's heart rate are made by using a pulse oximeter 5 seconds before and immediately after the local anesthetic injection.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, in the first session, pulpotomy of a mandibular primary molar will be performed by injecting inferior alveolar nerve block using lidocaine 2% with epinephrine 1: 100,000 (produced by Iran Pharmaceutical Company) and in the second session, pulpotomy of a primary molar will be performed on the other side of the mandible by crestal local injection using lidocaine 2% with epinephrine 1: 100000 (produced by Iran Pharmaceutical Company). Before and after the local anesthetic injection, changes in the child's pulse is measured using a pulse oximeter in both sessions. After an appropriate time (10 minutes) to determine the time of onset of anesthesia, IANB anesthesia is tested with a catheter after the child's lip feels numb, and CA anesthesia is tested immediately after injection into the second papilla. Then the caries removal process and preparation of the access cavity begin and the child's reaction is measured at the moment of pulp exposure. Before the treatment, the assistant will explain the Visual Analogue Scale (VAS) to the child and how to display the amount of discomfort on it, and immediately while preparing the access cavity in dentin or in case of need for pulp treatment at the time of pulp exposure. The child is asked to rate one of the smileys from zero (painless) to 10 (unbearable pain) based on the intensity of the pain he feels. The result is then recorded on the child form.
Category
Treatment - Drugs
2
Description
Intervention group 2: In this group, in the first session, pulpotomy of a mandibular primary molar will be performed by crestal local injection using lidocaine 2% with epinephrine 1: 100,000 (produced by Iran Pharmaceutical Company) and in the second session, pulpotomy of a primary molar will be performed on the other side of the mandible by crestal local injection using articaine 4% with epinephrine 1: 100000 (produced by Iran Pharmaceutical Company). Before and after the local anesthetic injection, changes in the child's pulse is measured using a pulse oximeter in both sessions. To determine the time of onset of anesthesia, CA anesthesia is tested immediately after injection into the second papilla. Then the caries removal process and preparation of the access cavity begin and the child's reaction is measured at the moment of pulp exposure. Before the treatment, the assistant will explain the Visual Analogue Scale (VAS) to the child and how to display the amount of discomfort on it, and immediately while preparing the access cavity in dentin or in case of need for pulp treatment at the time of pulp exposure. The child is asked to rate one of the smileys from zero (painless) to 10 (unbearable pain) based on the intensity of the pain he feels. The result is then recorded on the child form.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Parisa Jafari
Street address
Shafa Ave
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 8074 3211
Email
Parisajafaridnt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Shafa Ave
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 8074 3211
Email
Parisajafaridnt@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Parisa Jafari
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Ave
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 8074 3211
Email
Parisajafaridnt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Parisa Jafari
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Ave
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 8074 3211
Email
Parisajafaridnt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Parisa Jafari
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Ave
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 8074 3211
Email
Parisajafaridnt@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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available