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

NCT07647406 | Completed

• 1 other identifier: No.36/3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus Type 2

Keywords

intraseptal anaesthesia (ISA); periodontal ligament anaesthesia (PLA); computer- controlled local anesthetic delivery system (CCLADS); type 2 diabetes mellitus; articaine with epinephrine; local anaesthesia

Outcome Measures

Primary Outcomes (1)

• Anesthetic success rate

  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).

Secondary Outcomes (7)

• Onset time of local anesthesia

  Immediately after administration of local anesthesia (during procedure)

• Duration of soft tissue anesthesia

  During and after procedure (measured at 5-minute intervals until sensation returns)

• Width of anesthetic field

  10 minutes after successful anesthesia

• Systolic blood pressure changes

  Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection

• Diastolic blood pressure changes

  Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection

Study Arms (2)

ISA (Intraseptal Anaesthesia)

EXPERIMENTAL

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)

PLA (Periodontal Ligament Anaesthesia)

EXPERIMENTAL

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)

Interventions

Intraseptal anaesthesia (ISA) PROCEDURE

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.

ISA (Intraseptal Anaesthesia)

Periodontal ligament anaesthesia (PLA) PROCEDURE

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.

PLA (Periodontal Ligament Anaesthesia)

Eligibility Criteria

• Age: 35 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Business Academy in Novi Sad, Serbia: lead

Study Sites (1)

Faculty of Dentistry in Pančevo, University of Business Academy in Novi Sad

Pančevo, Vojvodina, Serbia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Vladimir Biocanin

  Faculty of Dentistry in Pancevo, Department of Oral Surgery, University of Business Academy in Novi Sad, Serbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: Participants with controlled Type 2 diabetes mellitus were randomly assigned to receive either intraseptal anaesthesia (ISA) or periodontal ligament anaesthesia (PLA) using a computer-controlled local anesthetic delivery system. The study compared the two interventions in a parallel-group design during tooth extraction procedures.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: January 11, 2026
• Primary Completion: April 17, 2026
• Study Completion: May 27, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)