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临床试验/CTRI/2024/09/074172
CTRI/2024/09/074172已完成2 期

Evaluating the Efficacy of Twin Mixed Local Anaesthesia and Local Anaesthesia with Submucosal Dexamethasone Injection in Mandibular Third Molar Surgery – Prospective Comparative Clinical Trial

Karthiga M1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2024年10月4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
39
试验地点
1
主要终点
POST OPERATIVE PAIN, FACIAL SWELLING AND MOUTH OPENING

研究概览

简要总结

This is a prospective clinical trial with computer based randomisation to access pain during injection, onset and duration of analgesia, post operative pain, mouth opening and facial swelling. There is difference in pain during injection, onset of anaesthesia, duration of analgesia, reduction of postoperative pain, facial swelling followed by improvement in mouth opening.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Subjects above the age of 21 with mesioangular impacted mandibular third molar of Pell & Gregory Class-I, Level A.
  • •Subjects who are in good physical status.
  • •Subjects who could understand and are willing to take part in the study and likely to comply with all study procedures.

排除标准

  • •Refusal to participate in the study.
  • •Pregnancy and lactation.
  • •Patient having systemic disorder like diabetes, hypertension, cardiac or neurological disorder.
  • •Patients with reduced mouth opening (mouth opening above 30mm was considered normal) Patient with history of drug allergy to lignocaine, dexamethasone, amoxicillin, metronidazole, diclofenac.
  • •Patients with active infection.
  • •Patient under any antibiotics or analgesics coverage.
  • •Patient other than Pell & Gregory Class-I Level A.
  • •Patients with severe oral manifestations of systemic disease.
  • •Psychologic or psychiatric conditions that could influence response to treatment.

结局指标

主要结局

POST OPERATIVE PAIN, FACIAL SWELLING AND MOUTH OPENING

时间窗: 7 days

次要结局

  • INTRAOPERATIVE PAIN(3 HOURS)
  • POST OPERATIVE PAIN, FACIAL SWELLING AND MOUTH OPENING(3rd day, 7th day)

研究者

发起方
Karthiga M
申办方类型
Other [pi]
责任方
Principal Investigator
主要研究者

Karthiga M

Sri Balaji Vidyapeeth

研究点 (1)

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