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

June 13, 2026 updated by: 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthetic success rate
Time Frame: 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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset time of local anesthesia
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Business Academy in Novi Sad, Serbia

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2026

Primary Completion (Actual)

April 17, 2026

Study Completion (Actual)

May 27, 2026

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 13, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.36/3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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