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临床试验/NCT03415724
NCT03415724Unknown不适用

Comparison of Anesthetic Efficacy of Dexmedetomidine and Epinephrine in Combination With 2% Lidocaine for Inferior Alveolar Nerve Block in Patients With Irreversible Pulpitis: A Prospective, Double Blinded, Randomized Controlled Trial.

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
pain intensity

研究概览

简要总结

Aim of the study is to determine and compare the anaesthetic efficacy of dexmedetomidine and epinephrine in combination with 2% lidocaine for inferior nerve block in patients with irreversible pulpitis. Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry & Endodontics. Vital mature permanent mandibular molars with radiographically exposed dentinal caries and with signs of irreversible pulpitis will be included in the study. The patients will be randomly allocated into two control and two experimental groups and nerve block will be given according to standard protocol.

详细描述

AIMS AND OBJECTIVES:

To evaluate the efficacy of conventional inferior alveolar nerve block in mandibular molars with symptomatic irreversible pulpitis with injection dexmedetomidine plus injection lignocaine and compare it with injection lignocaine plus adrenaline.

MATERIALS AND METHODS - Study subjects will be recruited from OPD of Department of conservative dentistry and endodontics, PGIDS, Rohtak.

METHODOLOGY- Prior to treatment, a thorough clinical and radiological examination will be carried out and a thorough history will be taken.

Clinical procedure:

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-50 years of age.
  • Patient willing to participate in the study.
  • Mature permanent mandibular first and second molars exhibiting signs of symptomatic irreversible pulpitis as assessed by history, cold and electric pulp tests.
  • Absence of periapical lesions on radiographic examination.

排除标准

  • Patient not ready to participate in the study voluntarily
  • Clinical history or electrocardiographic evidence of heart block, Ischaemic heart disease
  • Asthma, Sleep apnoea syndrome.
  • Impaired liver, renal or mental function.
  • Alcohol consumption in excess of 28 units per week.
  • Chronic sedative and analgesic user and those having known allergy to study drugs
  • Patients with severe periodontal disease.
  • Patients unable to return for recall appointments
  • Signs or symptoms of external /internal resorption, furcation or periapical radiolucency, swelling, or sinus tract.
  • Negative response to cold and electric pulp tests.
  • Antibiotic or analgesic intake within past 24 hours before treatment

研究组 & 干预措施

1.8 ml Lignocaine plus adrenaline

Active Comparator

The study subjects will receive conventional inferior alveolar nerve block with 1.8 ml of 2% inj lignocaine with adrenaline 1:80000.

干预措施: Inferior alveolar nerve block (Procedure)

3.6 ml Lignocaine plus adrenaline

Active Comparator

The study subjects will receive conventional inferior alveolar nerve block with 3.6 ml of 2% inj lignocaine with adrenaline 1:80000.

干预措施: Inferior alveolar nerve block (Procedure)

1.8 ml Lignocaine plus dexmedetomidine

Active Comparator

conventional inferior alveolar nerve block with1.8 ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml.

干预措施: Inferior alveolar nerve block (Procedure)

3.6 ml Lignocaine plus dexmedetomidine

Active Comparator

conventional inferior alveolar nerve block with3.6 ml of injection lignocaine plus injection dexmedetomidiene 1micromol/ ml.

干预措施: Inferior alveolar nerve block (Procedure)

结局指标

主要结局

pain intensity

时间窗: The root canal treatment will be completed in two sittings and the second sitting will be provided after 3-4 days.The time frame of the study is estimated to be about 6 months

After giving inferior alveolar nerve block as per the standard protocol, conventional access opening will be initiated after isolation with a rubber dam. Patients will be instructed to raise their hand if any pain felt during the procedure and rate the pain on heft parker VAS scale.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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