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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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™) |
|
| 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™) |
|
| 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™) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Dental Syringe | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Immediately after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dental fear (VAS, 0-10 cm) | Fear measured on a 10-cm VAS before and after injection; difference (ΔVAS) represents fear reduction. | Baseline (before injection) and immediately after injection |
| Pulse rate (bpm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Aydın University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery | Istanbul | Turkey (Türkiye) |
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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This is a randomized, parallel-arm superiority clinical trial with five intervention groups comparing anesthetic delivery systems for palatal infiltration.
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Single-blind design: outcome assessors and the statistician were blinded to group allocation.
| 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™) |
|
| 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. |
|
Pulse rate measured with fingertip oximeter at three time points: baseline (before injection), peri-procedural (during injection), and 3 minutes after injection.
| 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. | 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). | From the time of injection through study completion (average of 1 week follow-up) |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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