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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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

Other trials in Pakistan

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).

  1. 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.
  2. Monitor and document outcomes.
  3. Repeat the reading after 5 minutes
  4. 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 groups in NCT07633106
Study groupRoleWhat they receive
Diabetic patientsExperimentalAdministration 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 individualExperimentalAdministration 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.

  1. Effect of adrenaline (1:80,000) containing local anesthesia on glycemic level of diabetic patients and healthy individuals undergoing tooth extraction

    Measured: half hour

  2. Effect of adrenaline (1:80,000) containing local anesthesia on glycemic level of diabetic patients and healthy individuals undergoing tooth extraction

    Measured: 15-20mins

  3. 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.

  1. First posted8 Jun 2026
  2. Study start21 Feb 2026
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

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)
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

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.

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