Comparison of the anesthetic efficacy of alkalized lidocaine with non-alkalized lidocaine in infiltration injection of maxillary primary molars: a randomized clinical trial.
The anesthetic efficacy of alkalized lidocaine is different from that of non-alkalized lidocaine in infiltrating maxillary molars.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 25 patients, Random Allocation 1 software is used for randomization.
Settings and conduct
Location: Department of Pediatrics, Faculty of Dentistry, Shahid Yazd
The study is double-blind, the patient and the parents are unaware of the type of anesthetic injected in each session, and the dentist is also unaware of the fact that someone other than the performing dentist prepares the carpools.
After the injection, the onset of the local anesthetic effect with the elapsed time in seconds will be recorded by the performing dentist. From the time the local anesthesia is administered until the child feels tingling or numbness of the lips, tongue and corner of the lips (subjective symptoms) and does not feel pain during the probe (objective symptoms) will be recorded as the time of the onset of anesthesia effectiveness.
Participants/Inclusion and exclusion criteria
Children will be included in the study who are healthy according to the parents' report and need pulp treatment of primary molar teeth on both sides of the upper jaw. . Children with alveolar dental abscesses or chronic infectious conditions and children with a history of allergic reactions to local anesthetics will not be included in the study.
Intervention groups
Alkalized anesthetic injection in the intervention group and non-alkalized in the control group
Main outcome variables
Evaluation of the onset of anesthetic effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240511061732N1
Registration date:2024-05-18, 1403/02/29
Registration timing:prospective
Last update:2024-05-18, 1403/02/29
Update count:0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Zahra Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3526 0869
Email address
z.amirisimkooei@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-13, 1403/03/24
Expected recruitment end date
2024-07-19, 1403/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the anesthetic efficacy of alkalized lidocaine with non-alkalized lidocaine in infiltration injection of maxillary primary molars: a randomized clinical trial.
Public title
Comparison of the anesthetic efficacy of alkalized lidocaine with non-alkalized lidocaine in infiltration injection of maxillary primary molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
7-11-year-old children referred to the children's department of the Faculty of Dentistry who need pulp treatment of primary molar teeth on both sides of the maxilla.
According to the report of the parents, the children are healthy and do not have systemic diseases (hepatic, blood, kidney and digestive).
Children have not used analgesics on the day of treatment.
Children do not have learning disabilities and understand Persian language well.
Exclusion criteria:
Age
From 7 years old to 11 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
2
Right and left molars in each patient
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of anesthesia methods is done in each child separately. First, each child is considered as a block and based on the list of random numbers generated by the random allocation 1 software and the order of children's visits, one of the anesthesia methods will be used randomly for the first visit. The assignment of left or right tooth treatment will be done using red (left) and blue (right) cards, with the choice of the pediatric patient who chooses one of the cards in the first session. For a child who is injected with 2% alkalized lidocaine in the first session, one week after the first session in the second session, another anesthesia (2% non-alkalized lidocaine) will be prescribed in the other tooth.
Blinding (investigator's opinion)
Double blinded
Blinding description
The dentist is not aware of what anesthetic is being injected. Also, the child and his parents will not know the type of anesthetic injected.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
5 Abuzar Ghafari dead end، Alley 23, Ayatollah Khamenei St.,
City
Yazd
Province
Yazd
Postal code
8915147674
Approval date
2024-03-02, 1402/12/12
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1402.069
Health conditions studied
1
Description of health condition studied
Introducing and proposing a more effective anesthetic solution with less pain to relieve pain during the pulp treatment of children's teeth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Onset of action of anesthesia
Timepoint
After injection of anesthesia
Method of measurement
The onset of the effect of local anesthesia with the elapsed time in seconds will be recorded by the performing dentist. From the time the local anesthesia is administered until the child feels tingling or numbness of the lips, tongue and corner of the lips (subjective symptoms) and does not feel pain during the probe (objective symptoms) will be recorded as the time of the onset of anesthesia effectiveness.
Secondary outcomes
1
Description
Intensity of pain during anesthesia injection
Timepoint
During anesthetic injection
Method of measurement
For the objective evaluation of pain during anesthetic injection using the Wong-Baker FACES pain rating scale, for the subjective evaluation of pain during injection using the Sound scale; Eyes; Motor is used.
2
Description
Average blood oxygen level
Timepoint
Immediately before injection and five minutes after injection
Method of measurement
By pulse oximeter
3
Description
Average number of pulse beats
Timepoint
Immediately before injection and five minutes after injection
Method of measurement
By pulse oximeter
Intervention groups
1
Description
Intervention group: Alkalized lidocaine is used in the intervention group. To alkalize lidocaine 2% (Daropakhsh-Iran) together with adrenaline 80000: 1, with sodium bicarbonate, 0.18 ml of anesthetic solution is removed from the cartridge with a tuberculin syringe and that volume is discarded. then 0.18 ml of 8.4% sodium bicarbonate ampoule will be added to the cartridge. After that, the solution is gently shaken 20 times and when the preparation is finished, the injection is done.
Category
Treatment - Drugs
2
Description
Control group: In the control group, lidocaine anesthesia 2% (Daropakhsh-Iran) with adrenaline 80000: 1 is used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, Shahid Sadoughi Faculty of Dentistry, Yazd
Full name of responsible person
Zahra Amiri Simkooei
Street address
5 Abuzar Ghafari dead end, Alley 23 ,Ayatollah Khamenei St.
City
Yazd
Province
Yazd
Postal code
8915147674
Phone
+98 939 249 2726
Email
z.amirisimkooei@stu.ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.amin salehi
Street address
5 Abuzar Ghafari dead end، Alley 23, Ayatollah Khamenei St.
City
Yazd
Province
Yazd
Postal code
8915147674
Phone
+98 939 249 2726
Email
z.amirisimkooei@stu.ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Yazd University of Medical Sciences
Full name of responsible person
Zahra Amiri Simkooei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
5 Abuzar Ghafari dead end، Alley 23, Ayatollah Khamenei St
City
Yazd
Province
Yazd
Postal code
8915147674
Phone
+98 939 249 2726
Email
z.amirisimkooei@stu.ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Amiri Simkoorei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
5 Abuzar Ghafari dead end، Alley 23, Ayatollah Khamenei St.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۴۷۶۷۴
Phone
+98 939 249 2726
Email
z.amirisimkooei@stu.ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Amiri Simkooei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
5 Abuzar Ghafari dead end، Alley 23, Ayatollah Khamenei St.
City
Yazd
Province
Yazd
Postal code
8915147674
Phone
+98 939 249 2726
Email
z.amirisimkooei@stu.ssu.ac.ir
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