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临床试验/CTRI/2025/02/079995
CTRI/2025/02/079995尚未招募Phase 3 4

Comparative Evaluation of Efficacy Of Buffering of 2% Lignocaine Hydrochloride in Apicoectomy Procedure.

Department of Oral and Maxillofacial Surgery Dr DY Patil Dental College And Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年2月6日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
2. Discomfort score

研究概览

简要总结

Aim: The aim of this study is to evaluate and compare the efficacy of buffering of 2% lignocaine hydrochloride in apicoectomy procedure

Materials and methods: A Randomised triple blinded study is designed where 24 patients were selected for this study. Twenty-four patients will be randomly divided into group I and group II in equal numbers. In group I patients, 2% buffered LA and in group II patients, unbuffered LA will be administered. Enucleation of the cyst followed by apicoectomy procedure will be carried out in all the patients. Pain and discomfort score intra-operatively will be assessed along with number of times additional anaesthesia and amount of additional anaesthesia required during the procedure will be noted in both the groups and compared and evaluated.

Result : The collected data will be subjected to statistical analysis with chi square test and independent sample t test.

研究设计

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

入排标准

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

入选标准

  • Patients with periapical infection requiring apicoectomy in maxillary anterior region
  • Patients between 18-60 years of age.
  • Willingness to participate.

排除标准

  • EXCLUSION CRITERIA
  • Patients with history of tobacco chewing, alcohol consumption and smoking.
  • Patient with any of the following medical conditions: • Coagulation disorders • Metabolic disorders • Drug consumption leading to gingival hyperplasia • Pregnancy • History of radiotherapy, chemotherapy or having recently undergone any surgical procedures.

结局指标

主要结局

2. Discomfort score

时间窗: intraoperatively

3. Frequency of times of anaesthesia required

时间窗: intraoperatively

4. Amount of anaesthesia required

时间窗: intraoperatively

1. Pain

时间窗: intraoperatively

次要结局

  • 1. Amount of anaesthesia required(Intraoperatively)

研究者

发起方
Department of Oral and Maxillofacial Surgery Dr DY Patil Dental College And Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Manoj Bafna

DR D Y Patil Dental College And Hospital

研究点 (1)

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