Articaine Versus Lidocaine Supplemental Infiltration Efficacy in Irreversible Pulpitis Mandibular Molars After Failed Inferior Alveolar Nerve Block
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Anesthetic Success Rate of Supplemental Infiltration Injection
研究概览
简要总结
The purpose of this trial is to study the ability of a frequently used dental anesthetic (articaine) to achieve complete numbness of a diseased tooth with the most commonly used injection technique in the lower jaw (inferior alveolar nerve block: IANB). If this technique fails, a commonly used supplemental (SUP) technique with one of two possible dental anesthetics (lidocaine or articaine) will be given to evaluate the success/failure of complete numbness between the two anesthetics.
Standardized administration of anesthesia is provided by controlled delivery using Midwest Comfort Control Syringe.
The investigators hypothesize that supplemental infiltration anesthesia with articaine will give the same success rate as lidocaine in achieving complete pulpal anesthesia in mandibular molars with irreversible pulpits.
This study consisted of two periods of patient enrollment, treatment and data collection: Part I: 101 subjects; Part II: 100 subjects.
详细描述
The goal of the study is to achieve complete pulpal anesthesia in irreversible pulpitis mandibular molars, either by IANB administration of 4% articaine with 1:100,000 epinephrine (NDA 022466), or in case the IANB appeared to be clinically unsuccessful by supplemental infiltration of either articaine or lidocaine.
The proposed randomized controlled trial (RCT) aims to answer the following questions:
- What is the success rate of an IANB with articaine using a conventional IANB technique and standardized speed of administration?
- Is there a difference in complete pulpal anesthetic efficacy using supplemental infiltration with either articaine or lidocaine after an unsuccessful articaine IANB?
- Is there a difference in first or second molars in achieving complete pulpal anesthesia using supplemental infiltration with either articaine or lidocaine?
This study will combine the data from HUM00049692- Articaine Efficacy in Inflamed Molars to create a larger sample size, giving a total sample size of approximately 200 patients.
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
- Triple (Participant, Investigator, 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
- 否
入选标准
- •adult patients
- •irreversible pulpitis in mandibular molar
排除标准
- •below 18 years
研究组 & 干预措施
IANB Articaine
IANB Articaine: Inferior alveolar nerve block (IANB) anesthesia with articaine local anesthetic.
干预措施: IANB Articaine (Drug)
SUP Articaine
SUP Articaine: Supplemental buccal anesthesia (SUP) with articaine local anesthetic after unsuccessful IANB.
干预措施: IANB Articaine (Drug)
SUP Articaine
SUP Articaine: Supplemental buccal anesthesia (SUP) with articaine local anesthetic after unsuccessful IANB.
干预措施: SUP Articaine (Drug)
SUP Lidocaine
SUP Lidocaine: Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic after unsuccessful IANB.
干预措施: IANB Articaine (Drug)
SUP Lidocaine
SUP Lidocaine: Supplemental buccal anesthesia (SUP) with lidocaine local anesthetic after unsuccessful IANB.
干预措施: SUP Lidocaine (Drug)
结局指标
主要结局
Anesthetic Success Rate of Supplemental Infiltration Injection
时间窗: 5 min after injection
Following an unsuccessful IANB, supplemental infiltration anesthesia with either articaine or lidocaine was given to achieve complete pulpal anesthesia
次要结局
- Anesthetic Success Rate of an IANB With Articaine(15 min after injection)
研究者
Mathilde Peters, DMD, PhD
Principal Investigator
University of Michigan