Effect of 20% benzocaine gel on pain in inferior alveolar nerve block injections
Design
This study is a double blind clinical trial. Patients were randomly divided into two groups receiving 20% benzocaine gel as the intervention group and placebo gel receiving group (fluoride APF with the same taste and odor as benzocaine gel). After receiving these alveolar nerve block injections. Inferior. After the injection, the VAS scale is shown to the patient to indicate their pain level.The total sample size for each group (control and intervention) is equal to 58 samples.
Settings and conduct
This study is a double blind clinical trial. The study population was all patients referred to the Dental Clinic of Mazandaran University of Medical Sciences in 2018. The patients and surgeon are blinded.
Participants/Inclusion and exclusion criteria
The study population was all patients referred to the Dental Clinic of Mazandaran University of Medical Sciences in 2018 and the exclusion criteria were as follows:
1. Having a systemic illness in which the use of lidocaine anesthesia is partially or completely prohibited.
2. Existence of toothache
The rest of patients who do not qualify for exclusion are included.
Intervention groups
Patients were randomly divided into two groups receiving 20% benzocaine gel as the intervention group and placebo gel receiving group (fluoride APF with the same taste and odor as benzocaine gel). After receiving these alveolar nerve block injections. Inferior. After the injection, the VAS scale is shown to the patient to indicate their pain level.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151017024573N8
Registration date:2019-09-28, 1398/07/06
Registration timing:registered_while_recruiting
Last update:2019-09-28, 1398/07/06
Update count:0
Registration date
2019-09-28, 1398/07/06
Registrant information
Name
Mohadeseh Heidari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8351
Email address
mheidari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-16, 1398/06/25
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 20% benzocaine gel on the pain caused by lower alveolar nerve block injections
Public title
The effect of topical anesthesia on injection pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Indication of mandibular tooth extraction
Exclusion criteria:
Having a systemic disease in which the use of lidocaine anesthesia is partially or completely prohibited.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into intervention and control groups using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Application of placebo fluoride gel APF (master dent) with the same taste and odor as benzocaine gel
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Science, Imam square, sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4812685976
Approval date
2017-11-26, 1396/09/05
Ethics committee reference number
IR.MAZUMS..REC.1398.1181
Health conditions studied
1
Description of health condition studied
Extraction due to caries
ICD-10 code
k02.8
ICD-10 code description
Other dental caries
Primary outcomes
1
Description
Pain intensity
Timepoint
Before and after injection
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: topical anesthetic gel Benzocaine 20% (master-dent USA) put on a cotton swap as much as a pea after the area is dried with air.then it is applied for two minutes ( recommended factory duration) in 5 to 10 mm of gingiva in the vestibule area where the 27 gauge needle is to be inserted.one cartridge of 2% lidocaine ( daroopakhsh ) is injected at the site within a minute.
Category
Treatment - Drugs
2
Description
Control group:oral fluoride (APF gel thixotropic )(master-dent USA) put on a cotton swap as much as a pea after the area is dried with air.then it is applied for two minutes ( recommended factory duration) in 5 to 10 mm of gingiva in the vestibule area where the 27 gauge needle is to be inserted.one cartridge of 2% lidocaine ( daroopakhsh) is injected at the site within a minute.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran University of Medical Science,Sari Dental Faculty
Full name of responsible person
Mohadeseh Heidari
Street address
Faculty of Dentistry, University of Medical Sciences, near Tooba clinic, Khazar Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4816895476
Phone
+98 11 3565 5939
Email
heidari_mohadeseh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran university of Medical Science
Full name of responsible person
Farhad Sobouti
Street address
Faculty of Dentistry, University of Medical Sciences, near Tooba clinic, Khazar Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4816895477
Phone
+98 11 3325 4135
Email
farhad_sobouti@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran university of Medical Science
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
Tehran University of Medical Sciences
Full name of responsible person
Mohadeseh Heidari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran University of Medical Sciences, Dental Implant Research Center, Ghods Street, Enghelab Av,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
4816895477
Phone
+98 21 8897 8351
Fax
Email
mheidari@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohadeseh Heidari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran University of Medical Sciences, Dental Implant Research Center, Ghods Street, Enghelab Av,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
4816895477
Phone
+98 21 8897 8351
Fax
Email
mheidari@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohadeseh Heidari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran University of Medical Sciences, Dental Implant Research Center, Ghods Street, Enghelab Av,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
4816895477
Phone
+98 21 8897 8351
Fax
Email
mheidari@mazums.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
Not applicable
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