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Intraseptal and Periodontal Ligament Anaesthesia for Tooth Extraction in Patients With Type 2 Diabetes

13. juni 2026 opdateret af: Vladimir Biocanin, University of Business Academy in Novi Sad, Serbia

Efficacy and Safety of Intraseptal and Periodontal Ligament Anaesthesia for Extraction of Upper Lateral Incisors and Lower First Premolars in Patients With Type 2 Diabetes Mellitus

The goal of this clinical trial is to compare two local anesthesia techniques, intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA), in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.

The main questions it aims to answer are:

Which technique provides more effective local anesthesia for tooth extraction? Do ISA and PLA differ in their effects on blood pressure and heart rate during the procedure?

Researchers will compare ISA and PLA to determine which method is more effective and safer in this patient population.

Participants will:

Receive local anesthesia (ISA or PLA) using articaine with epinephrine delivered with a computer-controlled system Undergo extraction of a maxillary lateral incisor or mandibular first premolar Have blood pressure and heart rate measured before, during, and after anesthesia and extraction

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This randomized clinical trial was designed to evaluate and compare the clinical efficacy and safety of intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA) in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.

Local anesthetic administration in diabetic patients requires careful consideration due to potential cardiovascular responses and altered tissue sensitivity. Alternative injection techniques such as ISA and PLA may provide effective anesthesia while minimizing systemic effects.

A total of 120 participants were randomly assigned to receive either ISA or PLA. All anesthetic procedures were performed using a computer-controlled local anesthetic delivery system (CCLADS) with 0.6 mL of 4% articaine with 1:100,000 epinephrine (Septanest).

The study included extraction of maxillary lateral incisors and mandibular first premolars. Outcomes included anesthetic success rate, onset time, duration and extent of anesthesia, as well as changes in systolic and diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after the procedure.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Serbien
    • Vojvodina
      • Pančevo, Vojvodina, Serbien
        • Faculty of Dentistry in Pančevo, University of Business Academy in Novi Sad

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

Ingen

Beskrivelse

Inclusion Criteria:

  • Controlled Type 2 diabetes mellitus
  • Age 35-77 years
  • Patients requiring extraction of maxillary lateral incisors or mandibular first premolars
  • Teeth free of acute periodontal disease
  • No acute dentoalveolar abscess
  • No dental treatment within last 48 hours
  • No smoking
  • No alcohol or drug dependence
  • No contraindications to local anesthetic or vasoconstrictor

Exclusion Criteria:

  • Smokers
  • Patients with alcohol or drug dependence
  • Contraindications to local anesthetics or vasoconstrictors
  • Acute periodontal disease at the site of injection
  • Acute dentoalveolar abscess
  • History of tooth trauma or hypersensitivity in target teeth
  • Dental treatment within the last 48 hours prior to procedure
  • Non-controlled diabetes mellitus (implied, since study includes controlled DM only

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ISA (Intraseptal Anaesthesia)
Participants received intraseptal anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
Procedure: Intraseptal anaesthesia (ISA)
0.6 mL of 4% articaine with 1:100,000 epinephrine administered for intraseptal anaesthesia (ISA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
Eksperimentel: PLA (Periodontal Ligament Anaesthesia)
Participants received periodontal ligament anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
Procedure: Periodontal ligament anaesthesia (PLA)
0.6 mL of 4% articaine with 1:100,000 epinephrine administered for periodontal ligament anaesthesia (PLA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anesthetic success rate
Tidsramme: During tooth extraction procedure (5 minutes after administration of local anaesthesia).
Anesthetic success rate of intraseptal anaesthesia (ISA) compared with periodontal ligament anaesthesia (PLA) during extraction of maxillary lateral incisors and mandibular first premolars in patients with controlled Type 2 diabetes mellitus.
During tooth extraction procedure (5 minutes after administration of local anaesthesia).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Onset time of local anesthesia
Tidsramme: Immediately after administration of local anesthesia (during procedure)
Time from completion of anesthetic injection to the establishment of profound anesthesia in adjacent gingival tissue.
Immediately after administration of local anesthesia (during procedure)
Duration of soft tissue anesthesia
Tidsramme: During and after procedure (measured at 5-minute intervals until sensation returns)
Time period from onset of anesthesia until return of sensation confirmed by pinprick testing in buccal attached gingiva.
During and after procedure (measured at 5-minute intervals until sensation returns)
Width of anesthetic field
Tidsramme: 10 minutes after successful anesthesia
Extent (in millimeters) of anesthetized area in buccal/lingual/palatal attached gingiva and oral mucosa measured using pinprick testing and a flexible ruler.
10 minutes after successful anesthesia
Systolic blood pressure changes
Tidsramme: Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
Changes in systolic blood pressure before, during, and after administration of local anesthesia.
Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
Diastolic blood pressure changes
Tidsramme: Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
Changes in diastolic blood pressure during perioperative period of anesthesia administration.
Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
Mean arterial pressure changes
Tidsramme: Baseline to 30 minutes post-injection
Changes in mean arterial pressure during and after administration of local anesthesia.
Baseline to 30 minutes post-injection
Heart rate changes
Tidsramme: Baseline, during injection, and 5, 10, 15, 30 minutes after administration
Changes in heart rate during and after administration of local anesthesia using ECG monitoring.
Baseline, during injection, and 5, 10, 15, 30 minutes after administration

Samarbejdspartnere og efterforskere

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

Sponsor

University of Business Academy in Novi Sad, Serbia

Efterforskere

  • Ledende efterforsker: Vladimir Biocanin, Faculty of Dentistry in Pancevo, Department of Oral Surgery, University of Business Academy in Novi Sad, Serbia

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)

11. januar 2026

Primær færdiggørelse (Faktiske)

17. april 2026

Studieafslutning (Faktiske)

27. maj 2026

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • No.36/3

Plan for individuelle deltagerdata (IPD)

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IPD-planbeskrivelse

IPD will not be shared in order to protect participant privacy and ensure compliance with data protection regulations. Only summarized data will be made available in published results.

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