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Not yet recruitingNCT07901530Updated Oct 28, 2026

Effect of the CALAJECT System on Pain Perception, Heart Rate, and Blood Pressure During Inferior Alveolar Nerve Block: A Randomized Controlled Clinical Trial

An interventional study of Computer-Controlled Local Anesthetic Delivery System (CALAJECT) and Conventional Inferior Alveolar Nerve Block Injection in Local Anesthesia in Dentistry, sponsored by Inonu University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Inonu University · Not applicable, Interventional, and Other

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
286
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This randomized controlled clinical trial aims to compare the effects of a computer-controlled local anesthetic delivery system (CALAJECT) and the conventional injection technique for inferior alveolar nerve block (IANB) on injection pain, heart rate, and blood pressure in adult patients. Participants requiring dental treatment of mandibular posterior teeth will be randomly assigned to receive IANB using either the CALAJECT system or the conventional injection technique. Pain experienced during the anesthetic injection will be evaluated using a Visual Analog Scale (VAS). Heart rate and blood pressure will be recorded before and after the injection to evaluate cardiovascular responses. The study aims to determine whether the method of local anesthetic administration influences patient-reported pain and cardiovascular responses during IANB.

02

Conditions studied

  • Local Anesthesia in Dentistry

Keywords

  • Computer-Controlled Local Anesthesia
  • CALAJECT
  • Inferior Alveolar Nerve Block
  • Injection Pain
  • Visual Analog Scale
  • Heart Rate
  • Blood Pressure
03

In context

Lead sponsor

Inonu University is the lead sponsor of 391 studies on the registry; 93 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18-65 years
  • Systemically healthy patients
  • Individuals who voluntarily agree to participate in the study
  • Patients requiring restorative or endodontic treatment
  • Patients who have not used analgesics or antibiotics before treatment
  • Patients without acute pain before treatment
  • Non-smokers

Exclusion criteria

Exclusion Criteria:

  • Individuals with systemic diseases
  • Patients with an allergy to local anesthetic agents
  • Pregnant individuals
  • Patients with physical, mental, or cognitive disabilities
  • Patients receiving opioid or psychotropic drug therapy
  • Individuals who do not voluntarily agree to participate in the study
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
286 participants (estimated)

Study arms

  • Experimental
    CALAJECT Group

    Participants assigned to this group will receive an inferior alveolar nerve block using the CALAJECT computer-controlled local anesthetic delivery system.

    Device: Computer-Controlled Local Anesthetic Delivery System (CALAJECT)

  • Active comparator
    Conventional Injection Group

    Participants assigned to this group will receive an inferior alveolar nerve block using the conventional injection technique.

    Procedure: Conventional Inferior Alveolar Nerve Block Injection

Interventions

  • DeviceComputer-Controlled Local Anesthetic Delivery System (CALAJECT)

    Inferior alveolar nerve block anesthesia will be administered using the CALAJECT computer-controlled local anesthetic delivery system.

  • ProcedureConventional Inferior Alveolar Nerve Block Injection

    Conventional inferior alveolar nerve block anesthesia will be administered using a standard manual dental syringe.

06

What researchers measure

Primary outcomes

  1. Pain Perception During Inferior Alveolar Nerve Block Injection

    Pain associated with the inferior alveolar nerve block injection will be assessed using the Heft-Parker Visual Analog Scale (VAS). Participants will indicate their perceived pain intensity on the scale, with higher scores indicating greater pain intensity. Pain scores will be compared between the CALAJECT and conventional injection groups.

    Time frame: immediately after completion of the local anesthetic injection

Secondary outcomes

  1. Change in Heart Rate Associated With Local Anesthetic Injection

    Heart rate will be measured using a finger pulse oximeter placed on the left index finger. Heart rate will be recorded every 30 seconds for 2 minutes before the injection and every 30 seconds for 2 minutes immediately after completion of the injection. The mean heart rate for each 2-minute period will be calculated and compared between the CALAJECT and conventional injection groups.

    Time frame: From 2 minutes before injection to 2 minutes after completion of injection

  2. Change in Blood Pressure Associated With Local Anesthetic Injection

    Systolic and diastolic blood pressure will be measured using a digital blood pressure monitor on the left arm before and after the local anesthetic injection. Changes in blood pressure will be compared between the CALAJECT and conventional injection groups.

    Time frame: Before and immediately after completion of the local anesthetic injection

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Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07901530
Lead sponsor
Inonu University
Responsible party
Elcin Tekin Bulut (Assistant Profesor, Inonu University) — Principal investigator
First posted
Oct 28, 2026
Start date
Dec 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

aziz gunes
Contact
aziz.gunes@inonu.edu.tr
+90 5368148215
elçin tekin bulut
principal investigator · Inonu University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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