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临床试验/NCT03470532
NCT03470532已完成4 期

Comparing the Effect of 4% Articaine and 2% Mepivacaine Without Palatal Injection in Pain Assessment During Maxillary Teeth Extraction- A Randomized Clinical Trial

Melaka Manipal Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Measurement of pain intensity

研究概览

简要总结

This study compares the the efficacy of buccal infiltration of 4% Articaine and 2% Mepivacaine without any palatal injection during extraction of maxillary teeth. One group of patient receives buccal infiltration of Articaine and another group receives buccal infiltration of Mepivacaine.

详细描述

Dense local anesthesia is required to reduce pain during extraction of tooth. Administration of local anesthesia to the palatal mucosa is proved to be the most painful due to its firm adherence to the underlying periosteum and also it's abundant nerve supply. Articaine has greater lipid solubility and high bone penetration property. Mepivacaine is proven to be the safest local anaesthetic agent. Avoidance of a palatal injection during extraction will benefit the patient by reducing pain and anxiety to a greater extent.

So this study compares the bone penetration property between Articaine and Mepivacaine by assessing the pain in the palatal mucosa while extracting the tooth using only buccal infiltration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Patients aged 18 years and above
  • Patients requiring extraction of maxillary teeth which are grossly decayed, grade I mobile, root stumps or indicated for therapeutic extractions.
  • Healthy patients ( ASA I ) or patients with mild systemic disease with no functional limitations (ASA II).
  • Patients who are not allergic to the drugs used in the study

排除标准

  • Patients with periapical infections.
  • Patients who are on concurrent treatment with NSAIDs and corticosteroids

研究组 & 干预措施

Group B

Active Comparator

buccal infiltration of 2% Mepivacaine with epinephrine

干预措施: buccal infiltration of 2% Mepivacaine with Epinephrine (Drug)

Group A

Experimental

buccal infiltration of 4% Articaine with epinephrine

干预措施: buccal infiltration of 4% Articaine with Epinephrine (Drug)

结局指标

主要结局

Measurement of pain intensity

时间窗: Through the extraction procedure

pain intensity is measured using Visual Analogue Scale during extraction of tooth. The pain is marked from 0-100 mm in a 100 mm visul analogue scale ( 0= no pain, 100= extremely severe pain).

次要结局

  • Response rate(Through the extraction procedure)

研究者

发起方
Melaka Manipal Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdul Kalam Azad

Assistant Professor, Dept Of Oral and Maxillofacial Surgery

Melaka Manipal Medical College

研究点 (1)

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