Comparison of Five Anesthetic Delivery Systems for Palatal Infiltration: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain during injection (VAS, 0-10 cm)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Single-blind design: outcome assessors and the statistician were blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Conventional Dental Syringe (CDS)
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
干预措施: Conventional Dental Syringe (Device)
Manual Pressure Syringe (MCJ)
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™)
干预措施: Manual Pressure Syringe (MCJ, ASPIJECT™) (Device)
Spring-Activated Syringe (PCJ)
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™)
干预措施: Spring-Activated Syringe (PCJ, PAROJECT™) (Device)
Needle-Free Jet Injector (NFI)
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™)
干预措施: Needle-Free Jet Injector (NFI, Comfort-in™) (Device)
Computer-Controlled Local Anesthetic Delivery (CCLAD)
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™)
干预措施: Computer-Controlled Local Anesthetic Delivery (CCLAD, CALAJECT™) (Device)
结局指标
主要结局
Pain during injection (VAS, 0-10 cm)
时间窗: 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).
次要结局
- Change in dental fear (VAS, 0-10 cm)(Baseline (before injection) and immediately after injection)
- Pulse rate (bpm)(Baseline (before injection), peri-procedural (during injection), and 3 minutes post-injection)
- Oxygen saturation (SpO₂, %)(Baseline (before injection), peri-procedural (during injection), and 3 minutes post-injection)
- Adverse events(From the time of injection through study completion (average of 1 week follow-up))
研究者
Sercan Küçükkurt
Assoc. Prof. Dr. Sercan Küçükkurt, Oral and Maxillofacial Surgeon
Istanbul Aydın University