Determining the change of blood glucose concentration in compared to the basic state in type 2 diabetic patients and non-diabetic patients in 5th and 15th minute after injection.
Design
Clinical trial with control group.with parallel groups. non-blinded. non-randomized. phase 3 on 60 patients.
Settings and conduct
Tooba dental clinic - Sari -Iran.
In both groups, the basic level of blood glucose will be measured by a glucometer. Then, while the patient is in semi-supine position, two carpools of articaine 4% with epinephrine 1:200,000 will be injected by infiltration method. For this purpose, the needle will be inserted from the depth of the vestibule and the injection will be performed in the apex area of the desired tooth root. Then, level of blood glucose will be measured.(This study is non-blinded).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who:
1.Do not have any underlying disease or only have type 2 diabetes.
2. Their written consent has been obtained.
3. Their diabetes is controlled. (minimum 70 mg/dl and maximum 180 mg/dl.
Exclusion criteria:Parients who:
1.Are not suffering from any other underlying disease exept type 2 diabetes.
2. Are without written consent.
3. Their diabetes is not controlled.
Intervention groups
1. Intervention group: Diabetic patients receiving articaine with epinephrine 1:200,000.
2. Control group: non-diabetic patients receiving articaine with epinephrine 1:200,000.
Main outcome variables
Level of blood glucose (5 and 15 minutes after injection of articaine with 1:200000 epinephrine).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230225057537N1
Registration date:2023-07-04, 1402/04/13
Registration timing:registered_while_recruiting
Last update:2023-07-04, 1402/04/13
Update count:0
Registration date
2023-07-04, 1402/04/13
Registrant information
Name
amirhosein akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 933 989 6968
Email address
amirha8991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-26, 1402/04/05
Expected recruitment end date
2023-08-01, 1402/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of articaine with 1:200000 epinepherine on blood glucose in type 2 diabetic and non-diabetic patients.
Public title
Comparison of effect of articaine with 1:200000 epinepherine on blood glucose in diabetic and non-diabetic patients.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who, according to their own report, either do not have any underlying disease or only have type 2 diabetes.
Patients who need infiltration anesthesia.
Patients with written consent.
Patients who their diabetes is controlled. (minimum 70 mg/dl and maximum 180 mg/dl)
Exclusion criteria:
Patients who are suffering from any other underlying disease exept type 2 diabetes.
Patients who don't need infiltration anesthesia.
Patients without written consent.
Patients who their diabetes is not controlled.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
3
Blood glucose will be measured In 3 times. 1 Before injection 2.After 5 minutes of injection. 3. After 15 minutes of injection.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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 sciences. Farahabad blvd. Sari. Iran
City
sari
Province
Mazandaran
Postal code
4749146294
Approval date
2023-02-16, 1401/11/27
Ethics committee reference number
IR.MAZUMS.REC.1401.532
Health conditions studied
1
Description of health condition studied
Effect of articaine with 1:200000 epinephrine on blood glucose in diabetic and non-diabetic patients.
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose tolerance test
Primary outcomes
1
Description
Level of blood glucose
Timepoint
1.Before injection. 2.After. 5minutes of injection 3. After15minutes of injection.
Method of measurement
Blood glucose monitoring system (glucometer)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Changes of blood glucose after injection of articaine with 1:200000 epinephrine in type 2 diabetic patients. At first, in group of diabetic patients, the basic level of blood glucose concentration will be measured by a glucometer(before injection). Then, while the patient is in semi-supine position, two carpules of articaine 4% with epinephrine 1:200,000 will be injected by infiltration method. For this purpose, the needle will be inserted from the depth of the vestibule and the injection will be performed in the apex area of the desired tooth root. Blood glucose levels will be measured 5 and 15 minutes after injection.
Category
Treatment - Drugs
2
Description
Intervention group: Changes of blood glucose after articaine 1:100000 epinephrine in healthy(non-diabetic) patients.At first in group of non-diabetic patients, the basic level of blood glucose concentration will be measured by a glucometer. Then, while the patient is in semi-supine position, two carpules of articaine 4% with epinephrine 1:200,000 will be injected by infiltration method. For this purpose, the needle wil be inserted from the depth of the vestibule and the injection will be performed in the apex area of the desired tooth root. Blood sugar levels will be measured 5 and 15 minutes after injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tooba dental clinic
Full name of responsible person
Amirhosein Akbari
Street address
Tooba dental clinic. Sari. Iran
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3304 4000
Email
name@domain.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr seyed mahdi taghian
Street address
Mazandaran university of medical sciences. Beggining of valieasr highway. Sari
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3304 4000
Email
ravabetomoomi@mazums.ac.ir
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 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mehdi Taghian
Position
assistant professors and faculty member of mazandaran university of medical sciences.
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
office unit 610. 6th floor. shriar3 building . farhang str. sari
City
Sari
Province
Mazandaran
Postal code
.
Phone
+98 11 3330 5443
Fax
Email
m.taghian@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mehdi Taghian
Position
assistant professors and faculty member of mazandaran university of medical sciences.
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
office unit 610. 6th floor. shriar3 building . farhang str. sari
City
Sari
Province
Mazandaran
Postal code
.
Phone
+98 11 3330 5443
Fax
Email
m.taghian@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amirhosein Akbari
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tooba dental clinic. khazar blvd. Sari. Iran
City
Sari
Province
Mazandaran
Postal code
4749146294
Phone
+98 933 989 6968
Fax
Email
amirha8991@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Title and more details about the data/document
Part of the data such as information of main outcome can be shared
When the data will become available and for how long
Access period starts 6 month after the results are published.
To whom data/document is available
Documents will be available only to researchers working in academic and scientific institusions.
Under which criteria data/document could be used
The use of data to carry out new research projects is permitted.
From where data/document is obtainable
To the email address of the respondent; Amirhosein Akbari :
amirha8991@gmail.com
What processes are involved for a request to access data/document
After reviewing the incoming emails, the data will be send to the applicant.