Determination of the effect of dentistry anesthetic temperature on pain perception during inferior alveolar nerve block injection
Design
The present study is a parallel double-blind, randomized clinical trial on 23 patients. Excel software rand function will be used for randomization.
Settings and conduct
The present study was performed on volunteer medical students of Kurdistan University of Medical Science who have inclusion criteria and no exclusion criteria, in the period between September and October 1400 after obtaining informed and written consent in the pediatric ward of Kurdistan Dental School.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Medical students aged 18 to 25 years in the ASA I physical classification in terms of physical condition classification. Exclusion criteria: any pain, swelling, abscess or infection at the injection site, Allergic to lidocaine, systemic diseases, and contraindications to epinephrine in individuals, the presence of neuropathy in the face, and the use of NSAIDs, various analgesics, benzodiazepines, and anti-Depression in the two weeks before the intervention.
Intervention groups
Case group: The inferior alveolar nerve block is injected into one side of the mandible with DarouPakhsh Company Carpule of 2% lidocaine containing epinephrine 1: 80,000 is administered. Control group: After one week, On the opposite side of the mandible, the inferior alveolar inferior nerve block is injected with carpule containing an anesthetic solution at a temperature of 37 degrees (body temperature).
Main outcome variables
Pain perception
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210714051890N1
Registration date:2021-09-01, 1400/06/10
Registration timing:prospective
Last update:2021-09-01, 1400/06/10
Update count:0
Registration date
2021-09-01, 1400/06/10
Registrant information
Name
Parisa Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 8096
Email address
heydariparisssa@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-11, 1400/06/20
Expected recruitment end date
2021-10-02, 1400/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of dentistry anesthetic temperature on pain perception during inferior alveolar nerve block injection
Public title
Evaluation of the effect of anesthetic temperature on pain perception in dental injections
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteer medical students 18 to 25 years old
Healthy patients meeting the criteria of ASA physical status ‘I’
Exclusion criteria:
Any pain, swelling, abscess or infection at the injection site
Allergic to lidocaine
Presence of systemic diseases and contraindication to epinephrine in individuals
Presence of facial neuropathy
Taking NSAIDs, painkillers, benzodiazepines and antidepressants in the two weeks before the intervention
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
23
More than 1 sample in each individual
Number of samples in each individual:
2
Both sides of the jaw will be used as an example.
Randomization (investigator's opinion)
Randomized
Randomization description
The first injection in the mandible of half of the subjects was performed with anesthetic solution at a temperature of 37 degrees and in half of the subjects with a solution of 21 degrees. The subjects are numbered and randomly using Excel randomization method, we determine in which people the first injection should be done with anesthetic solution at 37 degrees and in which people with anesthetic solution at 21 degrees. And then we randomly determine with the same method that the first injection is done on the left side of the lower mandible or the right side.
Blinding (investigator's opinion)
Double blinded
Blinding description
The injector and the person being injected will not know the temperature of the anesthetic solution and the pain will be assessed by the injector who is unaware of the temperature of the anesthetic carpule.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2021-08-31, 1400/06/09
Ethics committee reference number
IR.MUK.REC.1400.127
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain score
Timepoint
Immediately after the first and second injections
Method of measurement
pain Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Inferior alveolar nerve block dentistry injection by direct method, with a 27-gauge needle and 1.8 ml of DarouPakhsh Company Carpule of 2% lidocaine containing epinephrine 1: 80,000 is administeredat with 21 °C (room temperature), to one side of the mandible of the participant in the study.The injection is performed by a dental specialist.
Category
Prevention
2
Description
Control group: Inferior alveolar nerve block dentistry injection by direct method , with a 27-gauge needle and 1.8 ml of DarouPakhsh Company Carpule of 2% lidocaine containing epinephrine 1: 80,000 is administered , which is brought to a temperature of 37 °C (body temperature) using a heater. Towards the opposite side of the mandible of the person participating in the study.The injection is performed by a dental specialist.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kurdistan University of Medical Sciences, Faculty of Medicine
Full name of responsible person
Soma Arabzade Moghadam
Street address
Faculty of Dentistry, Kurdistan University of Dentirtry, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616894581
Phone
+98 87 8833 3328
Email
heydariparisssa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Pasdaran Blvd, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 4645 3366
Email
maleki43@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Parisa Heydari
Position
Dentistry intern
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Kurdistan University of medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 4648 3366
Email
heydariparisssa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Soma Arabzade Moghadam
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Kurdistan University of Medical Sciences, Pasdaran Blvd,
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 4648 3366
Email
S.arabzade@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Parisa Heydari
Position
Dentistry intern
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Kurdistan University of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 8770 3366
Email
heydariparisssa@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is from the proposal, raw data and project reports
When the data will become available and for how long
Data is available from the legal system six months after publication for two years
To whom data/document is available
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences
Under which criteria data/document could be used
For legal issues and the need to use data in future studies
From where data/document is obtainable
Soma Arabzade Moghadam, Parisa Heydari
What processes are involved for a request to access data/document
After submitting a request to the research and technology secretary of Kurdistan University of Medical Sciences, the call should be held to the administrator for supply.