Local Anesthesia in DentistryNCT07901530
Effect of the CALAJECT System on Pain Perception, Heart Rate, and Blood Pressure During Inferior Alveolar Nerve Block: A Randomized Controlled Clinical Trial
A study testing Conventional Inferior Alveolar Nerve Block Injection in people with Local Anesthesia in Dentistry, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Local Anesthesia in Dentistry
- What is being tested?
- Conventional Inferior Alveolar Nerve Block Injection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Inonu University Faculty of Dentistry
Malatya, Malatya
aziz gunes, +90 5368148215, aziz.gunes@inonu.edu.tr
About this study
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.
- Conditions
- Local Anesthesia in Dentistry
- Being tested
- Computer-Controlled Local Anesthetic Delivery System (CALAJECT), Conventional Inferior Alveolar Nerve Block Injection
- Keywords
- Computer-Controlled Local Anesthesia, CALAJECT, Inferior Alveolar Nerve Block, Injection Pain, Visual Analog Scale, Heart Rate, Blood Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Controlled Local Anesthetic Delivery System (CALAJECT)Device
Inferior alveolar nerve block anesthesia will be administered using the CALAJECT computer-controlled local anesthetic delivery system.
Conventional Inferior Alveolar Nerve Block InjectionProcedure or surgery
Conventional inferior alveolar nerve block anesthesia will be administered using a standard manual dental syringe.
| Study group | Role | What they receive |
|---|---|---|
| CALAJECT Group | Experimental | Participants assigned to this group will receive an inferior alveolar nerve block using the CALAJECT computer-controlled local anesthetic delivery system. Receives: Device: Computer-Controlled Local Anesthetic Delivery System (CALAJECT) |
| Conventional Injection Group | Active comparator | Participants assigned to this group will receive an inferior alveolar nerve block using the conventional injection technique. Receives: Procedure: Conventional Inferior Alveolar Nerve Block Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after completion of the local anesthetic injection
Secondary outcomes (2)
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.
Measured: From 2 minutes before injection to 2 minutes after completion of injection
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.
Measured: Before and immediately after completion of the local anesthetic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Anesthesia in DentistryStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups to receive inferior alveolar nerve block using either the CALAJECT system or the conventional injection technique.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elcin Tekin Bulut, Inonu University
- Investigators
- elçin tekin bulut, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901530
- Sponsor's protocol ID
- TDH-2026-5280
- Other IDs
- TDH-2026-5280
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the CALAJECT System on Pain Perception, Heart Rate, and Blood Pressure During Inferior Alveolar Nerve Block: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07901530
- Acronym / sponsor ID
- TDH-2026-5280
- Conditions
- Local Anesthesia in Dentistry
- Keywords
- Computer-Controlled Local Anesthesia, CALAJECT, Inferior Alveolar Nerve Block, Injection Pain, Visual Analog Scale, Heart Rate, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups to receive inferior alveolar nerve block using either the CALAJECT system or the conventional injection technique.
| Arm | Type | Receives |
|---|---|---|
| CALAJECT Group | Experimental | Device: Computer-Controlled Local Anesthetic Delivery System (CALAJECT)Participants assigned to this group will receive an inferior alveolar nerve block using the CALAJECT computer-controlled local anesthetic delivery system. |
| Conventional Injection Group | Active comparator | Procedure: Conventional Inferior Alveolar Nerve Block InjectionParticipants assigned to this group will receive an inferior alveolar nerve block using the conventional injection technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-Controlled Local Anesthetic Delivery System (CALAJECT)Inferior alveolar nerve block anesthesia will be administered using the CALAJECT computer-controlled local anesthetic delivery system. | Device | CALAJECT Group |
| Conventional Inferior Alveolar Nerve Block InjectionConventional inferior alveolar nerve block anesthesia will be administered using a standard manual dental syringe. | Procedure or surgery | Conventional Injection Group |
Primary outcome
Pain Perception During Inferior Alveolar Nerve Block Injection
Time frame: immediately after completion of the local anesthetic 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.
2 secondary outcomes
Change in Heart Rate Associated With Local Anesthetic Injection
Time frame: From 2 minutes before injection to 2 minutes after completion of injection
Change in Blood Pressure Associated With Local Anesthetic Injection
Time frame: Before and immediately after completion of the local anesthetic injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
elçin tekin bulut principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Inferior Alveolar Nerve Block Injection in people with Local Anesthesia in Dentistry, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact aziz gunes (+90 5368148215, aziz.gunes@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Perception During Inferior Alveolar Nerve Block Injection (time frame: immediately after completion of the local anesthetic injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.