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临床试验/NCT01912755
NCT01912755已完成4 期

Anesthetic Efficacy of 4% Articaine (Mandibular Infiltration) and 2% Lidocaine (Alveolar Nerve Block), Associated With 1:100.000 Epinephrine, in Lower Molars With Irreversible Pulpits

University of Campinas, Brazil2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年2月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Pain perception 3

研究概览

简要总结

The aim of this study was to verify the effectiveness of an anesthetic called articaine for dental treatment, comparing it with an anesthetic commonly used in dental clinic: lidocaine. Two types of local anesthesia (oral injection) in accordance with the solution used were performed. For patients anesthetized with articaine, an injection of anesthesia close to the tooth to be treated was used. For the anesthetic lidocaine an injection on the cheek at the bottom of the mouth was made. Differences between both techniques are mainly regarding the area of numbness. In the injection with articaine only a small part of the lip and the tooth was anesthetized. With lidocaine injection, the lower region of the entire side of the tooth and half of the tongue on the same side was numbed. The treatment was electronic randomized and there was equal chance to one or another treatment. The investigators are studying this new form of anesthesia (near the tooth that was treated) to see if it can numb the tooth to an emergency treatment, if it really decreases the feeling of numbness and discomfort during the service. Patients receiving articaine were submitted to cone beam exam at no cost.

详细描述

Aim: This randomized clinical trial compared the anesthetic efficacy of buccal infiltration (BI) with 4% articaine (AR) and inferior alveolar nerve block (IANB) with 2% lidocaine (LI), both with 1:100,000 epinephrine, in symptomatic mandibular molars with irreversible pulpitis. Likewise, we compared the efficacy of the primary infiltration (BI or IANB) with one supplemental injection (intraligamentary infiltration with articaine for AR and BI with articaine for LI). The influences of buccal cortical bone thickness and root distances to buccal cortical bone on articaine performance (AR) were also evaluated using cone-beam tomography. methodology: Volunteers presenting symptomatic mandibular molars with irreversible pulpitis were randomly divided into two groups (30 for AR and 20 for LI). Success was recorded when complete pain-free treatment was achieved after primary injection or when one supplemental injection was needed for emergency endodontic procedures.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • long-lasting moderate to severe pain during cold test
  • absence of periapical radiolucency except for a widened periodontal ligament (evaluated in periapical radiographs)
  • vital coronal pulp on access opening

排除标准

  • Previous history of allergy to local anesthetics
  • Subjects with systemic diseases
  • Pregnancy and lactation
  • Subjects taking any kind of medication that could change or influence the outcome of this research
  • Subjects without painful symptoms
  • Negative thermal testing, periapical lesion, incomplete root formation, presence of fistula or abscess, cracks or fractures

结局指标

主要结局

Pain perception 3

时间窗: 10 minutes after injection

Patients received visual analogue scales (VAS) to record their pain perception ten minutes after local anesthetic injection.

次要结局

  • Buccal cortical bone thickness(one week after injection)
  • Basal pain perception(10 minutes before injection)
  • Pain perception 2(5 minutes before injection)
  • Root distance to the bone(one week after injection)

研究者

发起方
University of Campinas, Brazil
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francisco Groppo

Professor of Physiological Sciences Department

University of Campinas, Brazil

研究点 (2)

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