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临床试验/NCT05840913
NCT05840913已完成2 期

Comparison of Anaesthetic Effectiveness of Different Volumes of Articaine for Inferior Alveolar Nerve Block in Molar Teeth with Symptomatic Irreversible Pulpitis

Armed Forces Institute of Dentistry, Pakistan4 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2023年12月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
78
试验地点
4
主要终点
Pain Control

研究概览

简要总结

This is a randomized controlled trial comparing the anaesthetic efficacy of 1.8 and 3.6 mL of Articaine for inferior alveolar nerve block when treating mandibular molars with Irreversible Pulpitis

详细描述

An informed written consent of the patients will be obtained. (Annex-A).

Demographic details (including name, age, gender, contact) will be obtained on data collection forms. (Annex-B).

The principal investigator will perform the local anesthetic injection and the participants will be assigned to one of the groups.

Group 1: 1.8 mL articaine Group 2: 3.6 mL articaine

Before starting the treatment i.e. before administration of the anesthetic solution, each participant will receive an explanation regarding the Heft-Parker visual analog pain scale (VAS) and asked to rate their pain on a self-report questionnaire.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy patients, including age group 18-55 years old
  • Mandibular first molar tooth with symptomatic irreversible pulpitis
  • Normal periapical radiographic appearance
  • Moderate pain on Heft-Parker VAS ( > 54 mm and < 114 mm )
  • Lingering pain or prolonged response to the cold testing (more than 10 seconds)
  • Positive response to electric pulp testing

排除标准

  • Patients who have taken analgesic or anti-inflammatory drugs within 6 hours before treatment visit
  • History of allergy to 4% articaine or epinephrine
  • Patients with systemic diseases
  • Pregnant or lactating patients
  • Teeth with severe periodontal disease
  • Teeth with periapical radiolucency
  • Any type of medication that could potentially interact with the anesthetic solution (antihypertensives)

结局指标

主要结局

Pain Control

时间窗: 30 to 45 minutes

Pain was recorded on a self-report questionnaire using the visual analog pain scale (VAS) VAS was used for gauging pain before the administration of the anesthetic solution, after the cold test was performed, and during the endodontic therapy. The VAS scores were designated as; 0= no pain 1-3= mild pain 4-7= moderate pain 8-10= severe pain

次要结局

未报告次要终点

研究者

发起方
Armed Forces Institute of Dentistry, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kanza Zafar

Dr. Kanza Zafar, Principal Investigator and Resident Operative Dentistry and Endodontics

Armed Forces Institute of Dentistry, Pakistan

研究点 (4)

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