- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07633106
Effect of Adrenaline (1:80,000) Containing Local Anesthesia on Glycemic Level of Diabetic and Healthy Individuals Undergoing Tooth Extraction
Effect of Adrenaline (1:80,000) Containing Local Anesthesiaon Glycemic Level of Diabetic and Healthy Individuals Undergoing Tooth Extraction
Dental extraction is one of the most frequently performed surgical interventions worldwide, and local anaesthesia remains its pharmacological foundation.The addition of adrenaline (epinephrine) 1:80 000 to lignocaine 2 % is considered the gold-standard regimen because it prolongs pulpal anaesthesia, reduces peak plasma lignocaine levels, and improves operative visibility through local vasoconstriction. Nevertheless, adrenaline is a potent sympathomimetic amine that activates both α- and β-adrenergic receptors, thereby triggering metabolic cascades that can raise blood glucose. The clinical question is whether the minute doses deposited in the oral soft tissues (≈11 µg per cartridge) are sufficient to evoke a measurable hyperglycaemic response in normoglycaemic or diabetic individuals undergoing tooth extraction.
Published data are contradictory. A randomised crossover trial of 40 healthy volunteers reported a significant 0.59 mmol L-¹ increase in capillary glucose 30 min after 2 % lignocaine/1:80 000 adrenaline compared with 3 % prilocaine.[5,8]. Conversely, a larger observational study in Riyadh found no statistically significant glycaemic change in either well-controlled diabetics or normoglycaemic subjects receiving identical cartridges.[9] Discrepancies have been attributed to heterogeneous sample sizes (30-120 participants), variable timing of glucose measurement, failure to control for circadian cortisol peaks, and inconsistent exclusion of patients on β-blockers or metformin.Importantly, no multicentre trial has specifically isolated the 1:80 000 concentration; most investigations pooled 1:50 000, 1:100 000 and 1:200 000 formulations, limiting external validity to everyday dental practice.
The International Diabetes Federation (2021) estimates that 537 million adults live with diabetes, many of whom require urgent dental care. Even transient peri-operative hyperglycaemia (>10 mmol L-¹) can impair neutrophil chemotaxis, increase the risk of post-extraction alveolar osteitis and delay wound healing. Current UK and American dental guidelines offer conflicting advice: the Faculty of Dental Surgery (2019) states that vasoconstrictor concentrations ≤1:80 000 are "unlikely to cause clinically relevant hyperglycaemia," whereas the American Dental Association (2020) recommends "caution in insulin-dependent diabetics" without quantifying risk. A precise glycaemic profile following 1:80 000 adrenaline is therefore essential to inform evidence-based anaesthetic selection, pre-operative fasting instructions and post-operative glucose monitoring protocols, ultimately reducing diabetes-related morbidity in the dental chair.
METHOD 90 participants in total will be split into two equal groups for this study: Group A: Healthy individuals Group B: Individuals with a diagnosis of diabetes
The Institutional Ethical Review Board (IERB), Dow University of Health Sciences (DUHS), Karachi, will provide ethical permission for data collection before to start.
Every participant will receive complete information on the study's goals, methods, advantages, and any possible iside effects. They will be guaranteed that every piece of information gathered will be kept private and utilized only for study. Prior to inclusion, each subject will provide written informed permission.
A complete medical and dental history will be recorded, followed by a clinical examination to confirm eligibility. Participants will then be assigned to their respective groups.
The On Call EZ II Glucometer will be used to assess the blood glucose levels of both groups of patients prior to the administration of LA containing epinephrine (1: 80,000).
Prick finger with a lancet. Gently squeeze a tiny bit of blood onto the test strip from the base of the finger.
Then insert the strip into the meter. The blood sugar reading will show up within a few seconds.
- Monitor and document outcomes.
- Repeat the reading after 5 minutes
- Take one more reading after extraction All data will be documented in a structured proforma, including demographic details, medical history, type of diabetes management, pre- and post-extraction glucose readings, and any adverse events observed during the procedure.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 12345
- Dow University of Health and Sciences Karachi, Sindh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: For case group Patients with Diabetes Mellitus type II confirmed by HbA1c Patients with status of ASA I or II Patient undergoing nonsurgical extraction For control groupHealthy individuals having no diabetes Patient undergoing nonsurgical extraction
Exclusion Criteria: Patients who are allergic to local anesthesia Patients with systemic disease other than diabetesPregnant patient Patient not willing to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diabetic patients
Administration of local anesthesia containing 1:80000 adrenaline to the diabetic patient prior to tooth extraction to monitor subsequent glycemic changes
|
Administration of local anesthesia containing 1:80000 adrenaline prior to tooth extraction to monitor subsequent glycemic changes at baseline and post injection intervels
|
|
Experimental: Healthy individual
Administration of local anesthesia containing 1:80000 adrenaline to healthy non diabetic individual prior to tooth extraction to monitor subsequent glycemic changes
|
Administration of local anesthesia containing 1:80000 adrenaline prior to tooth extraction to monitor subsequent glycemic changes at baseline and post injection intervels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Effect of adrenaline (1:80,000) containing local anesthesia on glycemic level of diabetic patients and healthy individuals undergoing tooth extraction
Time Frame: half hour
|
half hour
|
|
Effect of adrenaline (1:80,000) containing local anesthesia on glycemic level of diabetic patients and healthy individuals undergoing tooth extraction
Time Frame: 15-20mins
|
15-20mins
|
|
Effect of adrenaline (1:80,000) containing local anesthesia on glycemic level of diabetic patients and healthy individual undergoing tooth extraction
Time Frame: half hour
|
half hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dr hadiqa noor, Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-4404/DUHS/Approval/2025/50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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