The Effect of Cold Atmospheric Plasma on Patient Comfort During Dental Infiltration Anesthesia: A Randomized Controlled Split-Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain Intensity During Local Anesthesia Injection
研究概览
简要总结
This study aims to investigate the effectiveness of cold atmospheric plasma, a laser-like biophysical method, in reducing injection pain experienced during local infiltration anesthesia in dental treatments. The purpose is to determine whether applying cold atmospheric plasma before the injection can decrease the level of pain at the injection site and improve patient comfort.
In this study, to help reduce the pain felt during the dental injection, some patients will receive a cold plasma application before the needle is administered. The device is held close to the gum area where the injection will be given-without touching the tissue-for about one minute to help the area relax. Afterwards, the standard local anesthetic injection is performed. On the opposite side of the mouth, only the normal injection will be given. Pain levels on both sides and patient satisfaction will be recorded through questions asked after the procedure.
If you choose to participate in this research, your dental treatments will still be completed, and the pain felt during the injection may be reduced. Additionally, by participating, you will contribute to scientific knowledge and to the development of a potential future treatment option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being between 18 and 40 years of age;
- •American Society of Anesthesiologists (ASA) physical status classification I (systemically healthy);
- •No known allergy or intolerance to local anesthetic agents or cold atmospheric plasma (CAP);
- •Presence of similar bilateral dental treatment indications in the maxilla or mandible.
排除标准
- •Pregnancy or breastfeeding;
- •Presence of active lesions, ulceration, or signs of infection in the mucosa at the injection site;
- •Immunodeficiency or systemic immunosuppressive therapy;
- •Use of anticoagulant medications;
- •Previous exposure to CAP therapy for any purpose;
- •History of allergy to local anesthetic agents;
- •Presence of neurological or psychiatric disorders that may affect pain perception.
结局指标
主要结局
Pain Intensity During Local Anesthesia Injection
时间窗: Immediately after injection
The primary outcome was the intensity of pain experienced during the injection, assessed by the patient using a visual analog scale (VAS). The VAS ranged from 0 to 10, where 0 represented "no pain" and 10 represented "unbearable pain." Immediately after
次要结局
- Patient satisfaction related to the injection experience(Immediately after injection)
研究者
Izzet Acikan
Assistant Professor
Kahramanmaras Sutcu Imam University