Comparison of the changes in blood sugar level following local anesthesia administration with and without epinephrine in well-controlled type II diabetic patients
Determining blood sugar changes following local anesthesia with and without epinephrine in controlled type II diabetes patients
Design
Clinical trial, double blind, phase 2 on 52 patients
Settings and conduct
In this study, the samples will be selected from the patients referred to the maxillofacial surgery department of Shahid Sadoughi Faculty of Dentistry, Yazd. The participants in the study will include patients with controlled diabetes between 20 and 60 years old who are candidates for maxillary premolar tooth extraction. A total of 52 patients with controlled diabetes from each group will be randomly and equally divided into two groups A (lidocaine with epinephrine 1.80000) and group B (lidocaine without epinephrine 1.80000).Anesthesia injection will be done by infiltration by the final year dental student. People's blood glucose levels will be measured by a glucometer before anesthesia injection and then 10 and 20 minutes after injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with controlled diabetes between 20 and 60 years old, candidates for maxillary premolar tooth extraction
HbA1c less than 7% in patients with diabetes
Patients should not use any other medicine other than hypoglycemic medicine
Exclusion criteria: patients with high stress level and in case of tooth root fracture during work, as well as patients who do not want to participate in the study.
Intervention groups
Patients with controlled diabetes from each group randomly and equally including two groups A (lidocaine with epinephrine 1.80000) and group B (lidocaine without epinephrine 1.80000)
Main outcome variables
Blood glucose changes following local anesthesia with and without epinephrine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210306050606N2
Registration date:2024-07-15, 1403/04/25
Registration timing:registered_while_recruiting
Last update:2024-07-15, 1403/04/25
Update count:0
Registration date
2024-07-15, 1403/04/25
Registrant information
Name
Adele Pouyafard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8342
Email address
a.pooyafard@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-05, 1403/03/16
Expected recruitment end date
2024-09-06, 1403/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the changes in blood sugar level following local anesthesia administration with and without epinephrine in well-controlled type II diabetic patients
Public title
Comparison of the changes in blood sugar level following local anesthesia administration with and without epinephrine in well-controlled type II diabetic patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 20 and 60 years old are candidates for maxillary premolar tooth extraction
Diabetic patients with controlled disease with HbA1c less than 7%
Patients should not use any other medicine other than hypoglycemic medicine
Exclusion criteria:
Patients with high stress levels
root of the tooth fracture during work
patients who do not want to participate in the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients with controlled diabetes will be randomly and equally divided into two groups A (lidocaine with epinephrine 1.80000) and group B (lidocaine without epinephrine 1.80000).In the two target groups, diabetic patients did not know the type of anesthetic injection with and without epinephrine.
The statistician is unaware of the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoghi of Yazd University of Medical Sciences
Street address
Dahe Fajr Blvd,Dental school of Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Approval date
2024-05-20, 1403/02/31
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1403.021
Health conditions studied
1
Description of health condition studied
well-controlled type II diabetic patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
changes in blood sugar level
Timepoint
Measuring the blood glucose level of people before the intervention and then 10, and 20 minutes later
Method of measurement
Glucometer device
Secondary outcomes
1
Description
Associated anxiety score
Timepoint
Before starting the intervention
Method of measurement
Beck Anxiety Index questionnaire
Intervention groups
1
Description
Group A patients with controlled diabetes were candidates to receive lidocaine without epinephrine 1.80000 and the blood glucose level of the subjects will be measured by a glucometer before anesthesia injection and then 10 and 20 minutes later.
Category
Treatment - Drugs
2
Description
This group of patients with controlled diabetes were candidates to receive lidocaine with epinephrine 1.80000, and the blood glucose level of the subjects will be measured by a glucometer before anesthesia injection and then 10 and 20 minutes later.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Maxillofacial Surgery, Shahid Sadoughi Faculty of Dentistry, Yazd
Full name of responsible person
Mohsen Barzegar
Street address
Dahe Fajr Blvd,Yazd school of dentistry
City
Yazd
Province
Yazd
Postal code
894881167
Phone
+98 35 3625 5881
Fax
+98 35 3625 0344
Email
mohsen.barzegar90@gmail.com
Web page address
https://ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Yazd University of Medical Sciences
Street address
Dahe Fajr Blvd, Yazd dental school university
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Fax
+98 35 3625 0344
Email
yazd.dent.sch@ssu.ac.ir
Web page address
http://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
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
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Barzegar
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dahe Fajr Blvd.Yazd Dental School University
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Fax
+98 35 3625 0344
Email
Yazd.dent.sch@ssu.ac.ir
Web page address
http://ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
mohsen.barzegar@gmail.com
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dahe Fajr Blvd.Yazd dental school university
City
Yazd
Province
Yazd
Postal code
8114815667
Phone
+98 35 3625 0344
Fax
+98 35 3625 0344
Email
yazd.dent.sch@ssu.ac.ir
Web page address
http://ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Barzegar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dahe Fajr Blvd.Yazd dental school university
City
Yazd
Province
Yazd
Postal code
8914815667
Phone
+98 35 3625 5881
Fax
+98 35 3625 0344
Email
yazd.dent.sch@ssu.ac.ir
Web page address
http://ssu.ac.ir
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