跳至主要内容
临床试验/CTRI/2024/04/065122
CTRI/2024/04/065122已完成Phase 3 4

Comparative Evaluation of Anesthetic Efficacy of two different Local Anesthetic Agents in Maxillary Posterior Teeth with Irreversible Pulpitis: A Prospective Randomized Double-Blind Study

EDE Sumit Nagaraj1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年4月10日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
入组人数
104
试验地点
1
主要终点
Subjective and Objective Signs of onset of complete pulpal anesthesia after the injection of the anesthetic agent

研究概览

简要总结

The present study aims to evaluate the efficacy of two different local anesthetic agents (Lidocaine 2% and Articaine 4%) in maxillary posterior teeth with irreversible pulpitis. The study is a Double Blind Randomized Clinical Trial with participant and outcome assessor blinded. The present study will be conducted in the Department of Conservative Dentistry and Endodontics, Dr. Ziauddin Ahmad Dental College, AMU. Patients will be selected from the pool of patients visiting the department of Conservative Dentistry and Endodontics, seeking endodontic treatment. Patients will be selected from the pool of patients visiting the department of conservative dentistry and endodontics with the chief complaints of pain in maxillary posterior teeth. A quorum of at least 104 volunteer patients fulfilling the inclusion criteria will be included in the study. The study will be conducted for about 1 and half years from the date of recruitement.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Those Patients who are at least 18 years old, having good oral and general health, possessing vital symptomatic maxillary posterior teeth,moderate to severe pain in the maxillary molar, a prolonged response to cold testing with an endofrost spray and an exaggerated response to electric pulp testing,the absence of any periapical radiolucency on radiographs except for a widened periodontal ligament, a vital coronal pulp on access opening, and the ability of subject to understand the use of pain scales.

排除标准

  • Subjects younger than 18 years of age or older than 50 years of age, patients having active pain in more than 1 maxillary molar, subjects taking any pain-relieving medication including over-the-counter analgesics at least 12 hours before enrolment in the study and swelling near the tooth in question.

结局指标

主要结局

Subjective and Objective Signs of onset of complete pulpal anesthesia after the injection of the anesthetic agent

时间窗: 15 minutes after the injection of the anesthetic agent, and the same shall be verified by negative response to electric pulp testing

次要结局

  • patients who have received the injection of the anesthetic agent must feel no pain during endodontic access opening & instrumentation(complete pulpal anesthesia 15 minutes after the injection & no sensation of pain up to 1 hour.)

研究者

发起方
EDE Sumit Nagaraj
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

EDE Sumit Nagaraj

Dr Ziauddin Ahmad Dental College & Hospital Aligarh Muslim University Aligarh

研究点 (1)

Loading locations...

相似试验

Comparison of the anesthetic efficacy of lidocaine... | 临床试验