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临床试验/NCT03225326
NCT03225326撤回4 期

Efficacy of Anterior and Middle Superior Alveolar (AMSA) Nerve Block Anesthesia Obtained by Articaine Computer-controlled and Conventional Delivery

University of Belgrade1 个研究点 分布在 1 个国家开始时间: 2016年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Success of Pulpal Anesthesia for Central Incisive

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 for maxillary teeth extraction.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • maxillary incisors canines or premolars indicated for extraction due to periapical pathology, root fracture or orthodontic treatment

排除标准

  • allergies to local anesthetic solution ingredients, food and drugs
  • alcohol and drugs abuse
  • heavy tobacco smoking

研究组 & 干预措施

Computer controlled 4% articaine delivery by Anaeject

Experimental

干预措施: Computer controlled 4% articaine delivery by Anaeject (Drug)

Conventional 4% articaine delivery by carpule syringe

Active Comparator

干预措施: Conventional 4% articaine delivery by carpule syringe (Drug)

结局指标

主要结局

Success of Pulpal Anesthesia for Central Incisive

时间窗: after 1 hour

Measured by pulp sensitivity to electrical pulp tester

Success of Pulpal Anesthesia for First Premolar

时间窗: after 1 hour

Measured by pulp sensitivity to electrical pulp tester

Success of Pulpal Anesthesia for Lateral Incisive

时间窗: after 1 hour

Measured by pulp sensitivity to electrical pulp tester

Success of Pulpal Anesthesia for Canine

时间窗: after 1 hour

Measured by pulp sensitivity to electrical pulp tester

Success of Pulpal Anesthesia for Second Premolar

时间窗: after 1 hour

Measured by pulp sensitivity to electrical pulp tester

次要结局

  • Systolic blood pressure at 5th minute(5th minute)
  • Systolic blood pressure at 15th minute(15th minute)
  • Duration First Premolar(up to 60 minutes)
  • Heart rate(baseline)
  • Heart rate at 5th minute(5th minute)
  • Onset Lateral Incisive(up to 8 minutes)
  • Onset First Premolar(up to 8 minutes)
  • Duration Canine(up to 60 minutes)
  • Onset Canine(up to 8 minutes)
  • Onset Central Incisive(up to 8 minutes)
  • Duration Central Incisive(up to 60 minutes)
  • Onset Second Premolar(up to 8 minutes)
  • Duration Lateral Incisive(up to 60 minutes)
  • Diastolic blood pressure at 5th minute(5th minute)
  • Duration Second Premolar(up to 60 minutes)
  • Systolic blood pressure(baseline)
  • Systolic blood pressure at 10th minute(10th minute)
  • Systolic blood pressure at 30th minute(30th minute)
  • Diastolic blood pressure(baseline)
  • Diastolic blood pressure at 10th minute(10th minute)
  • Diastolic blood pressure at 15th minute(15th minute)
  • Diastolic blood pressure at 30th minute(30th minute)
  • Heart rate at 10th minute(10th minute)
  • Heart rate at 15th minute(15th minute)
  • Heart rate at 30th minute(30th minute)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bozidar Brkovic, DDS, MSc, PhD, Professor

DDS PhD Professor

University of Belgrade

研究点 (1)

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