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Effect of Adrenaline (1:80,000) Containing Local Anesthesia on Glycemic Level of Diabetic and Healthy Individuals Undergoing Tooth Extraction

2. juni 2026 opdateret af: Dow University of Health Sciences

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).

  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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Sindh
      • Karachi, Sindh, Pakistan, 12345
        • Dow University of Health and Sciences Karachi, Sindh

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Eksperimentel: 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

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Dr hadiqa noor, Dr Ishrat ul Ebad Khan Institute of Oral Health Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. februar 2026

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

1. juli 2026

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IRB-4404/DUHS/Approval/2025/50

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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