Comparison between the affect of two local anesthesia on glycemic level in order to inform the dentists & surgeons to choose the best local anesthesia that makes the least glucose level change after anesthetic Injection & within the therapeutic procedure.
Design
Clinical trial with control group, Society based & practical, Double blinded, Randomized
Settings and conduct
This study is performed at Surgical Department of Shiraz Dental University.
One hundred patients who participate in this research will be divided into two groups of 50 and will be injected randomly with one of these anesthetic agents: Lidocaine or Mepivacaine
Injection method is inferior alveolar nerve block.
Before the injection, informed consent is signed and filled by the patients.
Glucose level is measured before the injection & also 20 minutes after the unjection (before extraction procedure).
After all, we analyze glucose level variation across two groups, using statistical approach.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients within the age of 18 to 50 years; Patients who have had breakfast at least one hour ago
Exclusion criteria:
Patients who have addiction; Diabetic patients (controlled or uncontrolled); Patients who are allergic to local anesthetic agents or NSAIDs; Patients who show allergic reactions after the injection; Highly stressed patients; Patients who show resistance to the injected anesthetic agent and need more than three carpules; Lidocaine contraindication cases
Intervention groups
In this study the intervention group is the one in which used anesthesia is Epinephrine containing Lidocaine, the other group in which the used anesthesia is Mepivacaine, is control group
Main outcome variables
The glucose level which is measured by glucometer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181114041651N1
Registration date:2022-10-31, 1401/08/09
Registration timing:registered_while_recruiting
Last update:2022-10-31, 1401/08/09
Update count:0
Registration date
2022-10-31, 1401/08/09
Registrant information
Name
Ehsan Aliabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 3192
Email address
aliabadie@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-19, 1401/07/27
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the impact of two local anesthesia (Epinephrine containing Lidocaine & Mepivacaine) On glycemic level
Public title
Comparison of the effect of Epinephrine containing Lidocaine and Mepivacaine on glycemic level
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients within the age of 18 to 50 years
Patients who have had breakfast at least one hour ago
Exclusion criteria:
Patients who have addiction
Diabetic patients (controlled or uncontrolled)
Patients who are allergic to local anesthetic agents or NSAIDs
Patients who show allergic reactions after the injection
Highly stressed patients
Patients who show resistance to the injected anesthetic agent and need more than three carpules
Lidocaine contraindication cases
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization, in this technique in order to randomize the participants selection, the permuted block method is used.
Participants are selected randomly to be injected by the group A & B anesthesia agents.
Blocks can be
AA,BB
AB,AB
BA,AB
BA,BA
&....
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, Outcome assessor, Data analyst
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2022-08-27, 1401/06/05
Ethics committee reference number
24766
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Glucose level
Timepoint
Before intervention and 20 minutes after the local anesthesia injection
Method of measurement
Blood glucose meter
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The patients who recieve Mepivacaine (Epinephrine free) as anesthetic agent
Category
Other
2
Description
Intervention group: Patients who recieve Lidocaine (Containing Epinephrine) as anesthetic agent
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz dentistry faculty
Full name of responsible person
Sara Gharabati
Street address
Dentistry faculty, Corner of Mehr Blvd., Qasrodasht St.
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 3626 3193
Email
dental@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahtab Memarpour
Street address
Vice-Chancellor for research, Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
https://research.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Aliabadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Maxillofacial surgeon
Street address
Corner of Mehr Blvd., Qasrodasht St., Dentistry faculty
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 3626 3193
Email
aliabadie@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Aliabadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Maxillofacial surgeon
Street address
َDentistry faculty, Corner of Mehr Blvd., Qasrodasht
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 3626 3193
Email
aliabadie@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Aliabadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Maxillofacial surgeon
Street address
Dentistry faculty, Corner of Mehr Blvd., Qasrodasht St.
City
Shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 71 3626 3193
Email
Aliabadie@sums.ac.ir
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
After publication of the article, in case of request from academic email, the corresponding author provides the requested information.
When the data will become available and for how long
After publication of the article, in case of request from academic email, the corresponding author provides the requested information.
To whom data/document is available
After publication of the article, in case of request from academic email, the corresponding author provides the requested information.
Under which criteria data/document could be used
After publication of the article, in case of request from academic email, the corresponding author provides the requested information.
From where data/document is obtainable
After publication of the article, in case of request from academic email, the corresponding author provides the requested information.
What processes are involved for a request to access data/document
After publication of the article, in case of request from academic email, the corresponding author provides the requested information.