NCT07184879

Comparison of Five Anesthetic Delivery Systems for Palatal Infiltration

Comparison of Five Anesthetic Delivery Systems for Palatal Infiltration: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Sercan Küçükkurt · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Dental Anxiety
• Pain
• Dental
• Palatal Anesthesia

Interventions

Type	Name	Description
DEVICE	Conventional Dental Syringe	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.
DEVICE	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	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	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	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2025-09-22
• Last updated: 2025-09-22

Locations

1 site across 1 country: Turkey (Türkiye)