Dental AnxietyPAL-INJECTNCT07184879
Comparison of Five Anesthetic Delivery Systems for Palatal Infiltration
A study testing Conventional Dental Syringe, Spring-Activated Syringe (PCJ, PAROJECT™) and Needle-Free Jet Injector (NFI, Comfort-in™) in people with Dental Anxiety and Pain, run by Sercan Küçükkurt at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized clinical trial evaluating five different anesthetic delivery systems for palatal infiltration in adults undergoing maxillary molar extraction. A total of 200 healthy volunteers were enrolled and randomly assigned to receive anesthesia using one of the following devices: conventional dental… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Pain, Dental
- What is being tested?
- Conventional Dental Syringe, Spring-Activated Syringe (PCJ, PAROJECT™) and Needle-Free Jet Injector (NFI, Comfort-in™)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- ASA physical status I or II
- No systemic conditions affecting anesthetic metabolism
- No known allergy to local anesthetics or vasoconstrictors
- No psychiatric disorders or anxiolytic medication
- Ability to provide written informed consent
Who cannot join
- Pregnancy or lactation
- Active infection at the injection site
- Diagnosed needle phobia
- Prior exposure to any of the tested injection systems
- Use of premedication, sedatives, or topical anesthetics on the day of the procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Aydın University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
Istanbul
About this study
Official title: Comparison of Five Anesthetic Delivery Systems for Palatal Infiltration: A Randomized Clinical Trial
This study is a randomized clinical trial evaluating five different anesthetic delivery systems for palatal infiltration in adults undergoing maxillary molar extraction. A total of 200 healthy volunteers were enrolled and randomly assigned to receive anesthesia using one of the following devices: conventional dental syringe, manual pressure syringe, spring-activated syringe, needle-free jet injector, or computer-controlled local anesthetic delivery system.
The purpose of the study is to compare patient-reported pain, dental fear, and physiological responses (pulse rate and oxygen saturation) associated with each system. The results are expected to provide evidence on which devices may improve patient comfort and cooperation during palatal infiltration procedures.
Read the detailed description
This randomized, parallel-arm superiority trial was conducted at Istanbul Aydın University, Faculty of Dentistry, between September 2023 and March 2025. Two hundred healthy adults (≥18 years) requiring maxillary molar extraction under palatal infiltration anesthesia were equally randomized into five groups (n=40).
All participants received 0.4 mL of 4% articaine with 1:100,000 epinephrine, delivered with one of the five systems. The primary outcome was pain perception measured immediately after injection using a visual analog scale (VAS). Secondary outcomes included changes in dental fear, pulse rate, oxygen saturation, and any adverse events.
The study was approved by the Istanbul Aydın University Ethics Committee. Written informed consent was obtained from all participants.
- Conditions
- Dental Anxiety, Pain, Dental, Palatal Anesthesia
- Being tested
- Conventional Dental Syringe, Spring-Activated Syringe (PCJ, PAROJECT™), Needle-Free Jet Injector (NFI, Comfort-in™), Computer-Controlled Local Anesthetic Delivery (CCLAD, CALAJECT™), Manual Pressure Syringe (MCJ, ASPIJECT™)
- Keywords
- Dental Anesthesia, Palatal Infiltration, Visual Analog Scale (VAS), Computer-Controlled Local Anesthetic Delivery (CCLAD), Needle-Free Jet Injector, Injection Pain, Patient Fear, Dental Fear
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Dental SyringeDevice
Palatal infiltration anesthesia using a conventional dental syringe with a 27G needle. A total of 0.4 mL of articaine 4% with epinephrine 1:100,000 was administered manually over 15-20 seconds following aspiration.
Spring-Activated Syringe (PCJ, PAROJECT™)Device
Palatal infiltration using a spring-activated push-button syringe (PAROJECT™). Two calibrated 0.2 mL doses of articaine 4% with epinephrine 1:100,000 were administered following aspiration.
Needle-Free Jet Injector (NFI, Comfort-in™)Device
Palatal infiltration using a needle-free jet injector (Comfort-in™). A total of 0.4 mL of articaine 4% with epinephrine 1:100,000 was delivered in less than one second at 4-5 bar pressure. Aspiration not applicable.
Computer-Controlled Local Anesthetic Delivery (CCLAD, CALAJECT™)Device
Palatal infiltration using a computer-controlled local anesthetic delivery system (CALAJECT™, Program I) with a 30G, 16 mm needle. AutoFlow rate 0.006-0.009 mL/s, with automatic aspiration after 5 seconds and constant microprocessor-controlled pressure. A total of 0.4 mL of articaine 4% with epinephrine 1:100,000 was administered.
Manual Pressure Syringe (MCJ, ASPIJECT™)Device
Palatal infiltration using a manual pressure-controlled syringe (ASPIJECT™) with a 30G, 16 mm needle. A total of 0.4 mL of articaine 4% with epinephrine 1:100,000 was administered manually over 15-20 seconds with aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Dental Syringe (CDS) | Experimental | Palatal infiltration using a conventional dental syringe with 27G needle; manual injection of 0.4 mL articaine with epinephrine over 15-20 seconds, with aspiration. Intervention Name: Device: Conventional Dental Syringe Receives: Device: Conventional Dental Syringe |
| Manual Pressure Syringe (MCJ) | Experimental | Palatal infiltration using ASPIJECT™ manual pressure syringe with 30G, 16 mm needle; manually controlled injection of 0.4 mL articaine with epinephrine over 15-20 seconds, with aspiration. Intervention Name: Device: Manual Pressure Syringe (ASPIJECT™) Receives: Device: Manual Pressure Syringe (MCJ, ASPIJECT™) |
| Spring-Activated Syringe (PCJ) | Experimental | Palatal infiltration using PAROJECT™ spring-activated syringe; two calibrated 0.2 mL doses of articaine with epinephrine following aspiration. Intervention Name: Device: Spring-Activated Syringe (PAROJECT™) Receives: Device: Spring-Activated Syringe (PCJ, PAROJECT™) |
| Needle-Free Jet Injector (NFI) | Experimental | Palatal infiltration using Comfort-in™ needle-free jet injector; 0.4 mL articaine with epinephrine delivered in <1 second, at 4-5 bar pressure; aspiration not applicable. Intervention Name: Device: Needle-Free Jet Injector (Comfort-in™) Receives: Device: Needle-Free Jet Injector (NFI, Comfort-in™) |
| Computer-Controlled Local Anesthetic Delivery (CCLAD) | Experimental | Palatal infiltration using CALAJECT™ Program I; 30G, 16 mm needle; AutoFlow delivery (0.006-0.009 mL/s) with automatic aspiration; microprocessor-controlled constant pressure. Intervention Name: Device: Computer-Controlled Local Anesthetic Delivery (CALAJECT™) Receives: Device: Computer-Controlled Local Anesthetic Delivery (CCLAD, CALAJECT™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during injection (VAS, 0-10 cm)
Pain perception recorded immediately after palatal infiltration using a 10-cm visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).
Measured: Immediately after injection
Secondary outcomes (4)
Change in dental fear (VAS, 0-10 cm)
Fear measured on a 10-cm VAS before and after injection; difference (ΔVAS) represents fear reduction.
Measured: Baseline (before injection) and immediately after injection
Pulse rate (bpm)
Pulse rate measured with fingertip oximeter at three time points: baseline (before injection), peri-procedural (during injection), and 3 minutes after injection.
Measured: Baseline (before injection), peri-procedural (during injection), and 3 minutes post-injection
Oxygen saturation (SpO₂, %)
Oxygen saturation measured with fingertip oximeter at three time points: baseline (before injection), peri-procedural (during injection), and 3 minutes after injection.
Measured: Baseline (before injection), peri-procedural (during injection), and 3 minutes post-injection
Adverse events
Recording of any immediate or delayed adverse events associated with anesthetic delivery (pain, swelling, bleeding, syncope, allergic reactions).
Measured: From the time of injection through study completion (average of 1 week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Sep 2023
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, parallel-arm superiority clinical trial with five intervention groups comparing anesthetic delivery systems for palatal infiltration.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sercan Küçükkurt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sercan Küçükkurt, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184879
- Sponsor's protocol ID
- IAU-PalatalRCT-2025
- Acronym
- PAL-INJECT
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality and ethical restrictions. Aggregate results are available in the published manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Five Anesthetic Delivery Systems for Palatal Infiltration: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07184879
- Acronym / sponsor ID
- PAL-INJECT / IAU-PalatalRCT-2025
- Conditions
- Dental Anxiety, Pain, Dental, Palatal Anesthesia
- Keywords
- Dental Anesthesia, Palatal Infiltration, Visual Analog Scale (VAS), Computer-Controlled Local Anesthetic Delivery (CCLAD), Needle-Free Jet Injector, Injection Pain, Patient Fear, Dental Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sercan KüçükkurtUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 22 Sep 2025 (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 study is a randomized clinical trial evaluating five different anesthetic delivery systems for palatal infiltration in adults undergoing maxillary molar extraction. A total of 200 healthy volunteers were enrolled and randomly assigned to receive anesthesia using one of the following devices: conventional dental syringe, manual pressure syringe, spring-activated syringe, needle-free jet injector, or computer-controlled local anesthetic delivery system.
The purpose of the study is to compare patient-reported pain, dental fear, and physiological responses (pulse rate and oxygen saturation) associated with each system. The results are expected to provide evidence on which devices may improve patient comfort and cooperation during palatal infiltration procedures.
Detailed description
This randomized, parallel-arm superiority trial was conducted at Istanbul Aydın University, Faculty of Dentistry, between September 2023 and March 2025. Two hundred healthy adults (≥18 years) requiring maxillary molar extraction under palatal infiltration anesthesia were equally randomized into five groups (n=40).
All participants received 0.4 mL of 4% articaine with 1:100,000 epinephrine, delivered with one of the five systems. The primary outcome was pain perception measured immediately after injection using a visual analog scale (VAS). Secondary outcomes included changes in dental fear, pulse rate, oxygen saturation, and any adverse events.
The study was approved by the Istanbul Aydın University Ethics Committee. Written informed consent was obtained from all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- This is a randomized, parallel-arm superiority clinical trial with five intervention groups comparing anesthetic delivery systems for palatal infiltration.
| Arm | Type | Receives |
|---|---|---|
| Conventional Dental Syringe (CDS) | Experimental | Device: Conventional Dental SyringePalatal infiltration using a conventional dental syringe with 27G needle; manual injection of 0.4 mL articaine with epinephrine over 15-20 seconds, with aspiration. Intervention Name: Device: Conventional Dental Syringe |
| Manual Pressure Syringe (MCJ) | Experimental | Device: Manual Pressure Syringe (MCJ, ASPIJECT™)Palatal infiltration using ASPIJECT™ manual pressure syringe with 30G, 16 mm needle; manually controlled injection of 0.4 mL articaine with epinephrine over 15-20 seconds, with aspiration. Intervention Name: Device: Manual Pressure Syringe (ASPIJECT™) |
| Spring-Activated Syringe (PCJ) | Experimental | Device: Spring-Activated Syringe (PCJ, PAROJECT™)Palatal infiltration using PAROJECT™ spring-activated syringe; two calibrated 0.2 mL doses of articaine with epinephrine following aspiration. Intervention Name: Device: Spring-Activated Syringe (PAROJECT™) |
| Needle-Free Jet Injector (NFI) | Experimental | Device: Needle-Free Jet Injector (NFI, Comfort-in™)Palatal infiltration using Comfort-in™ needle-free jet injector; 0.4 mL articaine with epinephrine delivered in <1 second, at 4-5 bar pressure; aspiration not applicable. Intervention Name: Device: Needle-Free Jet Injector (Comfort-in™) |
| Computer-Controlled Local Anesthetic Delivery (CCLAD) | Experimental | Device: Computer-Controlled Local Anesthetic Delivery (CCLAD, CALAJECT™)Palatal infiltration using CALAJECT™ Program I; 30G, 16 mm needle; AutoFlow delivery (0.006-0.009 mL/s) with automatic aspiration; microprocessor-controlled constant pressure. Intervention Name: Device: Computer-Controlled Local Anesthetic Delivery (CALAJECT™) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- ASA physical status I or II
- No systemic conditions affecting anesthetic metabolism
- No known allergy to local anesthetics or vasoconstrictors
- No psychiatric disorders or anxiolytic medication
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Active infection at the injection site
- Diagnosed needle phobia
- Prior exposure to any of the tested injection systems
- Use of premedication, sedatives, or topical anesthetics on the day of the procedure
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 |
|---|---|---|
| Conventional Dental SyringePalatal infiltration anesthesia using a conventional dental syringe with a 27G needle. A total of 0.4 mL of articaine 4% with epinephrine 1:100,000 was administered manually over 15-20 seconds following aspiration. | Device | Conventional Dental Syringe (CDS) |
| Spring-Activated Syringe (PCJ, PAROJECT™)Palatal infiltration using a spring-activated push-button syringe (PAROJECT™). Two calibrated 0.2 mL doses of articaine 4% with epinephrine 1:100,000 were administered following aspiration. | Device | Spring-Activated Syringe (PCJ) |
| Needle-Free Jet Injector (NFI, Comfort-in™)Palatal infiltration using a needle-free jet injector (Comfort-in™). A total of 0.4 mL of articaine 4% with epinephrine 1:100,000 was delivered in less than one second at 4-5 bar pressure. Aspiration not applicable. | Device | Needle-Free Jet Injector (NFI) |
| Computer-Controlled Local Anesthetic Delivery (CCLAD, CALAJECT™)Palatal infiltration using a computer-controlled local anesthetic delivery system (CALAJECT™, Program I) with a 30G, 16 mm needle. AutoFlow rate 0.006-0.009 mL/s, with automatic aspiration after 5 seconds and constant microprocessor-controlled pressure. A total of 0.4 mL of articaine 4% with epinephrine 1:100,000 was administered. | Device | Computer-Controlled Local Anesthetic Delivery (CCLAD) |
| Manual Pressure Syringe (MCJ, ASPIJECT™)Palatal infiltration using a manual pressure-controlled syringe (ASPIJECT™) with a 30G, 16 mm needle. A total of 0.4 mL of articaine 4% with epinephrine 1:100,000 was administered manually over 15-20 seconds with aspiration. | Device | Manual Pressure Syringe (MCJ) |
Primary outcome
Pain during injection (VAS, 0-10 cm)
Time frame: Immediately after injection
Pain perception recorded immediately after palatal infiltration using a 10-cm visual analog scale (VAS; 0 = no pain, 10 = worst imaginable pain).
4 secondary outcomes
Change in dental fear (VAS, 0-10 cm)
Time frame: Baseline (before injection) and immediately after injection
Pulse rate (bpm)
Time frame: Baseline (before injection), peri-procedural (during injection), and 3 minutes post-injection
Oxygen saturation (SpO₂, %)
Time frame: Baseline (before injection), peri-procedural (during injection), and 3 minutes post-injection
Adverse events
Time frame: From the time of injection through study completion (average of 1 week follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality and ethical restrictions. Aggregate results are available in the published manuscript.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Dental Syringe, Spring-Activated Syringe (PCJ, PAROJECT™) and Needle-Free Jet Injector (NFI, Comfort-in™) in people with Dental Anxiety and Pain, run by Sercan Küçükkurt 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 22 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during injection (VAS, 0-10 cm) (time frame: Immediately after 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 22 Sep 2025.