Glycemic LevelNCT07633106
Effect of Adrenaline (1:80,000) Containing Local Anesthesia on Glycemic Level of Diabetic and Healthy Individuals Undergoing Tooth Extraction
A study testing Local anesthesia with 1:80000 adrenaline in people with Glycemic Level, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycemic Level
- What is being tested?
- Local anesthesia with 1:80000 adrenaline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Feb 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dow University of Health and Sciences Karachi, Sindh
Karachi, Sindh, 12345
About this study
Official title: 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.
Read more
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.
- Conditions
- Glycemic Level
- Being tested
- Local anesthesia with 1:80000 adrenaline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthesia with 1:80000 adrenalineDrug
Administration of local anesthesia containing 1:80000 adrenaline prior to tooth extraction to monitor subsequent glycemic changes at baseline and post injection intervels
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Experimental | Administration of local anesthesia containing 1:80000 adrenaline to the diabetic patient prior to tooth extraction to monitor subsequent glycemic changes Receives: Drug: Local anesthesia with 1:80000 adrenaline |
| Healthy individual | Experimental | Administration of local anesthesia containing 1:80000 adrenaline to healthy non diabetic individual prior to tooth extraction to monitor subsequent glycemic changes Receives: Drug: Local anesthesia with 1:80000 adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of adrenaline (1:80,000) containing local anesthesia on glycemic level of diabetic patients and healthy individuals undergoing tooth extraction
Measured: half hour
Effect of adrenaline (1:80,000) containing local anesthesia on glycemic level of diabetic patients and healthy individuals undergoing tooth extraction
Measured: 15-20mins
Effect of adrenaline (1:80,000) containing local anesthesia on glycemic level of diabetic patients and healthy individual undergoing tooth extraction
Measured: half hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start21 Feb 2026
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic LevelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr hadiqa noor, Principal investigator, Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633106
- Sponsor's protocol ID
- IRB-4404/DUHS/Approval/2025/50
- Status last verified
- May 2026
- First submitted
- 2 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adrenaline (1:80,000) Containing Local Anesthesiaon Glycemic Level of Diabetic and Healthy Individuals Undergoing Tooth Extraction
- ClinicalTrials.gov ID
- NCT07633106
- Acronym / sponsor ID
- IRB-4404/DUHS/Approval/2025/50
- Conditions
- Glycemic Level
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 21 Feb 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | Experimental | Drug: Local anesthesia with 1:80000 adrenalineAdministration of local anesthesia containing 1:80000 adrenaline to the diabetic patient prior to tooth extraction to monitor subsequent glycemic changes |
| Healthy individual | Experimental | Drug: Local anesthesia with 1:80000 adrenalineAdministration of local anesthesia containing 1:80000 adrenaline to healthy non diabetic individual prior to tooth extraction to monitor subsequent glycemic changes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local anesthesia with 1:80000 adrenalineAdministration of local anesthesia containing 1:80000 adrenaline prior to tooth extraction to monitor subsequent glycemic changes at baseline and post injection intervels | Drug | Diabetic patients, Healthy individual |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr hadiqa noor principal investigator
Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthesia with 1:80000 adrenaline in people with Glycemic Level, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.