The effect of using local anesthetic gel on the amount of pain during the injection of dental local anesthesia
Design
The clinical trial containing control group, with parallel groups, single-blinded (patient), randomized by SPSS statistical software into blocks of 6, the expected sample size is 30 people (each person has two samples) and therefore the total sample size It is 60.
Settings and conduct
Surgery department of Semnan Faculty of Dentistry's patients will be included in the study if eligible. SPSS statistical software randomly selects the side of the jaw that the local anesthetic is applied first in each patient. Therefore, the side of the control and intervention groups is determined. In this single-blind study, due to the use of a placebo, the patient will not know the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: consent to participate in this study, Patients without systemic disease, Patients without epinephrine, lidocaine and benzocaine allergy, Patients who need tooth extraction and there is a tooth corresponding to the intervention tooth on the opposite side of the jaw arch as a reference tooth.
Exclusion criteria: Pregnant or Lactating patients, Patients who have taken systemic painkillers 4-6 hours before surgery, with localized abscess
Intervention groups
Intervention group: injection of local anesthesia along with the use of local anesthetic gel.
Control group: injection of local anesthesia using placebo.
Local anesthetic gel containing 20% lidocaine from Prodofix brand will be used, and then injection of 2% Xylopen anesthetic containing 20 mg lidocaine and 12.5 mg epinephrine. Vaseline petroleum jelly is used as a placebo. The interval between 2 intervention and control sessions will be 2 weeks.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221018056224N1
Registration date:2023-05-25, 1402/03/04
Registration timing:registered_while_recruiting
Last update:2023-05-25, 1402/03/04
Update count:0
Registration date
2023-05-25, 1402/03/04
Registrant information
Name
ramin ganjkhanloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 756 7586
Email address
raminganjkhanloo1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-21, 1402/02/31
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using local anesthesia gel on the amount of pain during dental anesthesia injection
Public title
The effect of using local anesthetic gel on the amount of anesthetic injection pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Full consent to participate in this study
Patients without systemic disease
Patients without epinephrine, lidocaine and benzocaine allergy
Patients who need tooth extraction and there is a tooth corresponding to the intervention tooth on the opposite side of the jaw arch as a reference tooth
Exclusion criteria:
Pregnant patients
Lactating patients
Patients who have taken systemic painkillers 4-6 hours before surgery
Patients with localized abscess
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
In each patient who enters the study, one side is considered as the control group, and the contralateral side is considered as the intervention group.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using blocks of six prepared by SPSS statistical software: in the first group, the first injection of anesthesia is performed on the right side of the jaw, and in the second group, the first injection of anesthesia is performed on the left side of the jaw. All injections will be performed by a maxillofacial surgeon in a room with an assistant. The use or non-use of anesthetic gel in the first injection will be randomly selected.
Blinding (investigator's opinion)
Single blinded
Blinding description
First, SPSS statistical software randomly selects which side of the jaw of the local anesthetic is applied first in each patient. Therefore, it is determined which side is selected as the control group and which side is the case group, and the anesthetic gel is applied. Based on the injection site, we define two areas and place the desired anesthesia at that point. Due to the fact that a placebo is used in the control group, the patient will be blinded to the use or non-use of local anesthetic gel.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences and Health Services Headquarters., Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2022-10-10, 1401/07/18
Ethics committee reference number
IR.SEMUMS.REC.1401.185
Health conditions studied
1
Description of health condition studied
Pain during local anesthetic injection
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Pain during local anesthetic injection
Timepoint
Immediately after the injection of anesthesia in each session, we ask the patient to express the amount of pain felt based on the Visual Analogue Scale chart, from one to ten. The interval between the first and second session is 2 weeks.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: injection of local anesthesia along with the use of local anesthetic gel. First, SPSS statistical software randomly selects which side of the jaw of the local anesthetic is applied first in each patient. Therefore, it is determined which side is selected as the control group and which side is the case group, and the anesthetic gel is applied. As a result, in the intervention group, after placing the local anesthetic gel, anesthesia injection is performed. Local anesthetic gel containing 20% lidocaine from Prodofix brand and then injection of 2% Xylopen anesthetic containing 20 mg lidocaine and 12.5 mg epinephrine. The interval between 2 intervention and control sessions will be 2 weeks.
Category
Treatment - Drugs
2
Description
Control group: injection of local anesthesia using placebo. First, SPSS statistical software randomly selects which side of the jaw of the local anesthetic is applied first in each patient. Therefore, it is determined which side is selected as the control group and which side is the case group, and the anesthetic gel is applied. As a result, in the control group, anesthesia injection is performed after placing the placebo substance. Vaseline petroleum jelly is used as a placebo, and then the injection of 2% xylopen anesthetic containing 20 mg of lidocaine and 12.5 mg of epinephrine is performed. The interval between 2 intervention and control sessions will be 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Semnan University of Medical Sciences
Full name of responsible person
Ramin Ganjkhanloo
Street address
Faculty of Dentistry., Semnan University of Medical Sciences., 17 shahrivar blvd., Semnan.
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3332 1026
Email
raminganjkhanloo1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Seyed Vahid Dehnad
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry., Semnan University of Medical Sciences., 17 shahrivar blvd., Semnan.
City
Semnan
Province
Semnan
Postal code
۳۵۱۸۷۹۴۴۳۱
Phone
+98 23 3332 1026
Email
s.vahid-dehnad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyed Vahid Dehnad
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry., Semnan University of Medical Sciences., 17 shahrivar blvd., Semnan.
City
Semnan
Province
Semnan
Postal code
۳۵۱۸۷۹۴۴۳۱
Phone
+98 23 3332 1026
Email
s.vahid-dehnad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Seyed Vahid Dehnad
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry., Semnan University of Medical Sciences., 17 shahrivar blvd., Semnan.
City
Semnan
Province
Semnan
Postal code
۳۵۱۸۷۹۴۴۳۱
Phone
+98 23 3332 1026
Email
s.vahid-dehnad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
there is not more information
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