The Effectiveness of Automated Soft Tissue Vibration in Reducing Pain and Accelerating Action of Intraoral Local Anesthesia Injections in Adult Dental Patients. A Randomized Crossover Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Pain of needle penetration of palatal LA injection
研究概览
简要总结
The clinical trial will compare pain perception during dental local anesthesia injections with and without using soft tissue vibration device prior to injection. The primary goal is to test the effectiveness of such devices in pain/discomfort reduction during intraoral local anesthesia injections in various techniques (infiltration and block anesthesia).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical status class I
- •Planned for multiple dental treatments in the maxilla and mandible bilaterally
排除标准
- •Patients <18 years old
- •Pregnant ladies
- •Smokers and alcoholics
- •Patients on medications
- •Drug abusers
- •Never received dental treatment under local anesthesia before
- •Patients with an acute infection with or without fever
- •Patients with preoperative pain
研究组 & 干预措施
Pain of buccal injection with DentalVibe®
DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) buccal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection.
干预措施: DentalVibe® Comfort Injection System (Device)
Pain of buccal injection with DentalVibe®
DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) buccal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection.
干预措施: Lidocaine Epinephrine (Drug)
Pain of buccal injection without DentalVibe®
Local anesthesia (LA) for buccal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.
干预措施: Lidocaine Epinephrine (Drug)
Pain of palatal injection with DentalVibe®
DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) palatal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection.
干预措施: DentalVibe® Comfort Injection System (Device)
Pain of palatal injection with DentalVibe®
DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) palatal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection.
干预措施: Lidocaine Epinephrine (Drug)
Pain of block injection with DentalVibe®
DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) injection for inferior alveolar nerve (IAN) block. The LA to be used is Lidocaine 2% with Epinephrine dental injection.
干预措施: Lidocaine Epinephrine (Drug)
Pain of palatal injection without DentalVibe®
Local anesthesia (LA) for palatal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.
干预措施: Lidocaine Epinephrine (Drug)
Pain of block injection with DentalVibe®
DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) injection for inferior alveolar nerve (IAN) block. The LA to be used is Lidocaine 2% with Epinephrine dental injection.
干预措施: DentalVibe® Comfort Injection System (Device)
Pain of block injection without DentalVibe®
Local anesthesia (LA) injection for inferior alveolar nerve (IAN) block using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection.
干预措施: Lidocaine Epinephrine (Drug)
结局指标
主要结局
Pain of needle penetration of palatal LA injection
时间窗: 1-2 seconds after mucosal penetration
The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Pain of needle penetration of IAN block LA injection
时间窗: 1-2 seconds after mucosal penetration
The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Pain of needle penetration of buccal LA injection
时间窗: 1-2 seconds after mucosal penetration
The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Pain of anesthesia delivery during IAN block LA injection
时间窗: 30 seconds after LA solution delivery
The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Pain of anesthesia delivery during buccal LA infiltration
时间窗: 30 seconds after LA solution delivery
The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Pain of anesthesia delivery during palatal LA infiltration
时间窗: 30 seconds after LA solution delivery
The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
次要结局
未报告次要终点
研究者
Ra'ed Salma
Assistant Professor
Riyadh Colleges of Dentistry and Pharmacy