Randomized Prospective Split Mouth Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain response in the gingiva
研究概览
简要总结
The purpose of the study is to evaluate two different ways to administer the numbing solution. One is with a conventional needle and syringe the other method iontophoresis is a machine that supplies a weak current through electrodes that touch your teeth. Both methods use an anesthesia solution to make your teeth numb but the iontophoresis system contains no needle and the delivery device does not penetrate the gum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Subject is at least 18 years of age at the time of consent
- •Subject is able to provide their own informed consent
- •Subject has a minimum 24 teeth/subject and 6 teeth per quadrant
- •Subject has an Approximal Plaque Index score ≤ 40% as assessed via explorer and without the use of plaque-disclosing agents
- •Subject must be able to speak and understand English
- •Subject is able and willing to return for all scheduled study visits
- •Subject to able to make dental appointments
- •Subject should not be a pregnant female
- •Subject meets the Level-I or Level-II classification criteria of the American
- •Society of Anesthesiologists (ASA) Physical Status Classification System For Dental Patient Care
排除标准
- •Subject has any of the following:
- •rampant caries
- •chronic periodontitis
- •salivary gland dysfunction
- •Subject is unable, for any reason, to tolerate the procedure time required to place the restorations
- •Subject has unacceptable oral hygiene (e.g., chronic moderate to heavy plaque accumulation along the gumline)
- •Subject is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study
- •Subject is using a whitening agent at any time during this study.
- •Subject has history of allergic reaction to anesthetic medications
- •Subject with uncontrolled systemic disease or conditions
- •Subject is having acute or chronic myofascial pain or neuropathic conditions
- •Subject taking long-term analgesics for their systemic conditions
- •Subject presenting with acute dental pain
- •Subject requiring IV sedation or nitrous oxide sedation or oral sedation for anxiety
研究组 & 干预措施
Iontophoresis of Tetracaine and oxymetazoline
干预措施: Iontophoresis of Tetracaine and oxymetazoline (Drug)
Local Anesthesia (lidocaine hydrochloride)
干预措施: Local Anesthesia (lidocaine hydrochloride) (Drug)
结局指标
主要结局
Pain response in the gingiva
时间窗: Up to 1 hour
Pain response in the gingiva will be recorded as a yes/no after a painful stimulus is applied using a probe on the buccal and palatal soft tissues.
Cold pulp test
时间窗: Up to 1 hour
The pulpal response will be assessed using a cold pulp test as yes/ no response.
次要结局
- Pain scale: Visual analog scale(Baseline and 2 minutes after delivery of anesthesia.)
- Beck's anxiety scale(Baseline and 2 minutes after delivery of anesthesia.)