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临床试验/NCT02536430
NCT02536430已完成2 期

Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block in Patients With Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial

Nahid Mohammadzadeh Akhlaghi1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Efficacy of Ketorolac infiltration on success rate of inferior alveolar nerve block

研究概览

简要总结

The aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis. Forty adult volunteers with including criteria has been randomly divided into two groups (n=20). All patients received standard inferior alveolar nerve block injection. After achieving the lip numbness, one group received a buccal infiltration of Ketorolac and the other one received a buccal infiltration of Normal Saline as placebo. Any pain during root canal treatment has been recorded using analog visual scale. The success was considered as none or mild pain during treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.

详细描述

Objectives:

The aim of this study was to determine whether combining an intraoral injection of a non steroidal anti-inflammatory drug (Ketorolac), in association with conventional inferior alveolar nerve block, would improve the success rate in teeth with irreversible pulpitis.

Design: Randomized double blind clinical trial

Setting and conduct: Forty adult volunteers will randomly divide into two groups (n=20). All patients will receive standard inferior alveolar nerve block injection of 4% Articaine with 1:100000 epinephrine and supplemental buccal infiltration of 0.9 mL 4% Articaine with 1:100000 epinephrine. After five minutes when the lip numbness was achieved, one group received supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine and other group received buccal infiltration of normal saline. Endodontic access preparation initiated after 15 minutes of initial IANB with two negative responses to the electric pulp test. Pain during caries and dentin removal, access cavity preparation and canal length measurements has been recorded using visual analog scale (VAS). The success was considered as none or mild pain during the treatment. The data have been analyzed using Mann-U-Whitney and chi-squared tests.

Participants including major eligibility criteria: all patients with symptomatic irreversible pulpitis (Heft Parker VAS ≥54) of a mandibular molar tooth without systemic diseases; non smoking; without any medicine consumption or analgesic and sedation Intervention: Ketorolac infiltration

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

入选标准

  • patients with age ranged 18-65;
  • without systemic diseases;
  • without any medicine consumption;
  • non smoking;
  • non pregnant;
  • non breast feeding;
  • with symptomatic irreversible pulpitis (Visual Analog Scale ≥ 54) in one mandibular molar that needs root canal treatment

排除标准

  • 未提供

研究组 & 干预措施

buccal infiltration of Normal Saline

Placebo Comparator

A buccal infiltration of Normal Saline was applied for the patients in control group.

干预措施: Placebo (Drug)

Buccal infiltration of Ketorolac

Active Comparator

A buccal infiltration of 30 mg/mL of Ketorolac Tromethamine was applied for the patients in case group.

干预措施: Ketorolac Tromethamine (Drug)

结局指标

主要结局

Efficacy of Ketorolac infiltration on success rate of inferior alveolar nerve block

时间窗: One week

次要结局

未报告次要终点

研究者

发起方
Nahid Mohammadzadeh Akhlaghi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nahid Mohammadzadeh Akhlaghi

Doctor Nahid Mohammadzadeh Akhlaghi

Azad University of Medical Sciences

研究点 (1)

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