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Completed

NCT Number: NCT07647406

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

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

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Pančevo, Vojvodina, Serbia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Mean arterial pressure changes

    Time frame: Baseline to 30 minutes post-injection

    Changes in mean arterial pressure during and after administration of local anesthesia.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Business Academy in Novi Sad, Serbia

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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