Efficacy and Safety of Pulpal Anesthesia After Anterior and Middle Superior Alveolar (AMSA) Nerve Block Obtained by Articaine Computer-controlled and Conventional Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Duration of pulpal anesthesia
研究概览
简要总结
The purpose of this study was to investigate and compare pulpal anesthesia and cardiovascular parameters obtained with 0.6 ml of 4% articaine with epinephrine (1:100.000) for anterior and middle superior alveolar nerve (AMSA) block performed by standard and computer-controlled delivery in healthy volunteers.
详细描述
Traditionally, pulpal anesthesia is obtained by infiltration or mandibular nerve block. However, it is not always possible to achieve complete pulpal anesthesia with previously mentioned anesthetic techniques.
It is well documented that administration of 0,6-0,9 ml of anesthetic solution with palatal approach with anterior middle superior injection (AMSA) provided successful pulpal anesthesia from central incisor to second premolar. In addition, palatal soft tissues from midpalate to free gingiva and from central incisor to first molar are fully anesthetized with AMSA. The injection site is located at a point that bisects the maxillary first and second premolars, and midway between the crest of the free gingival margin and mid-palatine suture. The needle is orientated at a 45-degree angle with the bevel facing the palatal tissue. AMSA presents intraosseous anesthetic technique.
Traditionally, palatal injection administered with conventional syringe was described as very painful. On the other hand, computer controlled local anesthetic delivery system (CCLADS) has been recommended for AMSA as a system which allows slow administration of anesthetic solution, with constant pressure. It was shown that AMSA do not provide undesired buccal and upper lip anesthesia.
The AMSA technique has been recommended for proce¬dures ranging from operative restorations, crown preparation to scaling and root planning.
The aim of this study is to evaluate and compare parameters of pulpal anesthesia and cardiovascular function after AMSA injection of 4% articaine with epinephrine (1:100.000), delivered by conventional syringe or CCLADS. Study sample will comprise 30 healthy (ASA1) volunteers who will receive 0.6 ml 4% articaine with epinephrine (1:100.000) by conventional syringe, and after two-week washout period the same amount of local anesthetic by CCLADS. Parameters of pulpal and soft tissue anesthesia (onset and duration) for all maxillary teeth on the anesthetized side, as well as parameters of cardiovascular function (systolic blood pressure, diastolic blood pressure, heart rate) will be monitored and compared.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •full maxillary dental arch
- •vital maxillary teeth without caries, restorations, periodontal disease or history of trauma
排除标准
- •allergies to local anesthetic solution ingredients, food and drugs
- •alcohol and drugs abuse
- •heavy tobacco smoking
结局指标
主要结局
Duration of pulpal anesthesia
时间窗: up to 64 minutes from baseline
Duration of pulpal maxillary anesthesia of all maxillary teeth in anesthetized side of upper jaw assessed by electrical pulp testing at 2-minute intervals.
次要结局
- Onset of pulpal anesthesia(Up to 8 minutes)
- Width of anesthetic field marginal-superior(5 minutes)
- Diastolic blood pressure at baseline(0 minutes)
- Width of anesthetic field medial-lateral(5 minutes)
- Duration of soft tissue anesthesia buccal(Up to 120 min)
- Duration of soft tissue anesthesia palatal(Up to 120 minutes)
- Systolic blood pressure at baseline(0 minutes)
- Systolic blood pressure at 5 minutes(0, 5 minutes)
- Systolic blood pressure at 10 minutes(0, 10 minutes)
- Systolic blood pressure at 15 minutes(0, 15 minutes)
- Systolic blood pressure at 20 minutes(0, 20 minutes)
- Systolic blood pressure at 35 minutes(0, 35 minutes)
- Diastolic blood pressure at 5 minutes(0, 5 minutes)
- Diastolic blood pressure at 10 minutes(0, 10 minutes)
- Diastolic blood pressure at 15 minutes(0, 15 minutes)
- Diastolic blood pressure at 20 minutes(0, 20 minutes)
- Diastolic blood pressure at 35 minutes(0, 35 minutes)
- Heart rate at baseline(0 minutes)
- Heart rate at 5 minutes(0, 5 mninutes)
- Heart rate at 10 minutes(0, 10 minutes)
- Heart rate at 15 minutes(0, 15 minutes)
- Heart rate at 20 minutes(0, 20 minutes)
- Heart rate at 35 minutes(0, 35 minutes)
研究者
Bozidar Brkovic, DDS, MSc, PhD, Professor
DDS PhD Professor
University of Belgrade