Evaluation of changing Blood Glucose serum level After Local Anesthetic Injection During Tooth Extraction

Last registered on July 20, 2014
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Pre-Trial

Trial Information

General Information

Title
Evaluation of changing Blood Glucose serum level After Local Anesthetic Injection During Tooth Extraction
RCT ID
AEARCTR-0000445
Initial registration date
July 20, 2014

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
July 20, 2014, 7:13 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country
Iran (Islamic Republic of)
Region
Tehran

Primary Investigator

Name
Hamidreza Mahaseni Aghdam
Affiliation
Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2014-02-01
End date
2014-05-31
Keywords
Health
Additional Keywords
Anesthesia, Local, Epinephrine, Glucose, Lidocaine, Tooth Extraction
JEL code(s)
Secondary IDs
Abstract
Background: Injection of local anesthesia during dental procedures can induce metabolic changes. The purpose of this study is to evaluate the changes of blood glucose serum level after injection of lidocaein with vasoconstrictor during Tooth Extraction
Materials and Methods: In this clinical trial study, we enrolled 60 patients. We extracted mandibular teeth by using inferior alveolar nerve block. We took a finger blood sample test from each enrolled patient immediately before and 10 minutes after local anesthesia. Anesthetic solution (1.8 ml carpule) contained lidocaine and 1:80,000 epinephrine. It was injected through inferior alveolar nerve after negative aspiration. Only one carpule injected into all patients. This study is approved by ethics committee of the research center of Azad University of Medical Sciences
Results: Mean age in our study was 39.54 ± 15 years old. 35 patients were male and 25 were female. The blood glucose serum level was 111.6 ± 25.47 mg/dl before local anesthesia and 115.3 ± 24.39 mg/dl after tooth extraction (P = 0.418). 11 female patient’s and 4 male patients had blood glucose level reduction after injection. There was a significant difference between groups (P = 0.01).
Conclusion: according to our findings and previous reports, using local anesthesia during teeth extraction doesn’t induce hypoglycemia and it could increase the blood glucose serum level in individuals.
External Link(s)

Registration Citation

Citation
Mahaseni Aghdam , Hamidreza. 2014. "Evaluation of changing Blood Glucose serum level After Local Anesthetic Injection During Tooth Extraction." AEA RCT Registry. July 20. https://doi.org/10.1257/rct.445-1.0
Former Citation
Mahaseni Aghdam , Hamidreza. 2014. "Evaluation of changing Blood Glucose serum level After Local Anesthetic Injection During Tooth Extraction." AEA RCT Registry. July 20. https://www.socialscienceregistry.org/trials/445/history/2146
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
Our local anesthesia solution was (1.8 ml carpule) contained lidocaein and 1:80000 epinephrines and it was injected in 1 minute through inferior alveolar nerve block after negative aspiration. Only one carpule injected in all patients.

Intervention Start Date
2014-02-01
Intervention End Date
2014-05-01

Primary Outcomes

Primary Outcomes (end points)
We took a finger blood sample immediately before and 10 minutes after local anesthesia. We used a glucometer (Accu Check Active, model GC, made in Germany) to measured blood glucose samples.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
We include all adult individuals how referred to our department for mandibular teeth extractions and we exclude patients how underwent teeth extractions both in mandible and maxilla, known history of diabetes, infection or any contraindications for using epinephrine. Our local anesthesia solution was (1.8 ml carpule) contained lidocaein and 1:80000 epinephrines and it was injected in 1 minute through inferior alveolar nerve block after negative aspiration. Only one carpule injected in all patients.
We took a finger blood sample immediately before and 10 minutes after local anesthesia. We used a glucometer (Accu Check Active, model GC, made in Germany) to measured blood glucose samples.
Experimental Design Details
Randomization Method
Public lottery
Randomization Unit
individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
60
Sample size: planned number of observations
60
Sample size (or number of clusters) by treatment arms
60
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
Azad University of Medical Sciences
IRB Approval Date
2014-03-01
IRB Approval Number
6743
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials