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临床试验/NCT04900571
NCT04900571已完成4 期

Comparison of Single Antibiotic Paste Nitrofurantoin and Calcium Hydroxide Paste as Intracanal Medicaments in Alleviating Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis -A Randomized Controlled Trial

Altamash Institute of Dental Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月1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
入组人数
60
试验地点
1
主要终点
Group 3: Control

研究概览

简要总结

Intracanal medicaments have been frequently used in patients with endodontic and periradicular infection for the elimination of microorganisms. Commonly used includes Double Antibiotic Paste, Triple Antibiotic Paste, and Calcium Hydroxide. This study aims to compare the efficacy in alleviating pain between intracanal medicaments Nitrofurantoin and Calcium Hydroxide Paste. 60 patients were randomly divided into 3 groups, each group having 20 patients as following: Group 1: Nitrofurantoin, Group 2: Calcium Hydroxide and Group 3: Control. Preoperative pain was recorded using a numerical pain scale. Pre-operative pain score was initially recorded, followed by Post-operative pain at 12, 24, 48, and 72 hours. Nitrofurantoin has been proven to be an effective intracanal medicament in alleviating immediate post-operative pain in patients with symptomatic irreversible pulpitis as compared to calcium hydroxide.

详细描述

Intracanal medicaments have been frequently used in patients with endodontic and periradicular infection for the elimination of microorganisms. Commonly used includes Double Antibiotic Paste, Triple Antibiotic Paste, and Calcium Hydroxide. This study aims to compare the efficacy in alleviating pain between intracanal medicaments Nitrofurantoin and Calcium Hydroxide Paste.

60 patients were randomly divided into 3 groups, each group having 20 patients as following: Group 1: Nitrofurantoin, Group 2: Calcium Hydroxide and Group 3: Control. Preoperative pain was recorded using a numerical pain scale. After access preparation, chemomechanical preparation was performed with subsequent placement of intracanal medicaments. Pre-operative pain score was initially recorded, followed by Post-operative pain at 12, 24, 48, and 72 hours, respectively. Root canal treatment was performed in single root teeth with patients suffering from symptomatic irreversible pulpitis.

Total of 20 patients were randomized into 3 groups. Majority of the patients in all 3 groups initially presented with moderate to severe pre-operative pain. After 72 Hours post-operatively, 50% patients in group 1 reported no pain, while 5% patients in both group 2 and 3 had no pain. Pain significantly subsided in group 1 as compared to group 2 and 3. Regarding age and gender, both had no significant relationship with the pain scores in all of the 3 groups.

Nitrofurantoin has been proven to be an effective intracanal medicament in alleviating immediate post-operative pain in patients with symptomatic irreversible pulpitis as compared to calcium hydroxide. While the control group with no intracanal medicament showed little reduction in pain scores. So, nitrofurantoin can be used as a substitute to currently available standard intracanal medicaments.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • No medical history
  • no age restrictions
  • no history of allergy to medications used in root canal treatment
  • patients suffering from Symptomatic Irreversible Pulpitis

排除标准

  • Patients who were not suitable for conventional root canal treatment
  • multirooted teeth

研究组 & 干预措施

Nitrofurantoin

Experimental

Measuring pain score using numerical pain scale post-operatively at different time intervals.

干预措施: Nitrofurantoin 100 MG (Drug)

Calcium Hydroxide

Experimental

Measuring pain score using numerical pain scale post-operatively at different time intervals.

干预措施: Nitrofurantoin 100 MG (Drug)

Control

Experimental

Measuring pain score using numerical pain scale post-operatively at different time intervals.

干预措施: Nitrofurantoin 100 MG (Drug)

结局指标

主要结局

Group 3: Control

时间窗: 5 months

Measuring incidence of Post-operative Pain using Numerical Pain Scale

Group 1: Nitrofurantoin

时间窗: 5 months

Measuring incidence of Post-operative Pain using Numerical Pain Scale

Group 2: Calcium Hydroxide

时间窗: 5 months

Measuring incidence of Post-operative Pain using Numerical Pain Scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hira Abbasi

Principal Investigator

Altamash Institute of Dental Medicine

研究点 (1)

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