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临床试验/NCT07270159
NCT07270159已完成不适用

EFFECT OF PROBIOTICS, DOUBLE ANTIBIOTIC AND CALCIUM HYDROXIDE PASTE AS INTRACANAL MEDICAMENTS ON POSTOPERATIVE PAIN IN SYMPTOMATIC IRREVERSIBLE PULPITIS PATIENTS. A RANDOMIZED CONTROLLED TRIAL

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Postoperative Pain Intensity

研究概览

简要总结

The goal of this clinical trial is to learn whether probiotics, double antibiotic paste (DAP), or calcium hydroxide paste help reduce postoperative pain after root canal treatment in adults with symptomatic irreversible pulpitis.

It will also learn about the safety of these medicaments.

The main questions it aims to answer are:

Do probiotics, DAP, or calcium hydroxide lower the amount of pain patients experience after the first visit of root canal treatment? What medical problems or side effects do participants experience when any of these medicaments are used? Researchers will compare probiotics, DAP, and calcium hydroxide to see which one works best to control postoperative pain.

Participants will:

Receive one of the three intracanal medicaments (probiotics, DAP, or Ca(OH)₂) placed inside their root canal Visit the clinic for follow-ups according to the treatment plan Report their pain levels using a Visual Analog Scale (VAS) at several time points (before treatment, 12 hrs, 24 hrs, 48 hrs, 3 days, and 7 days) Inform the research team about any discomfort, symptoms, or side effects during the week after treatment

详细描述

This randomized controlled clinical trial aims to evaluate the effectiveness of three intracanal medicaments-probiotics, double antibiotic paste (DAP), and calcium hydroxide-in reducing postoperative pain in adult patients diagnosed with symptomatic irreversible pulpitis undergoing root canal treatment. The study will compare changes in pain intensity over time using the Visual Analog Scale (VAS) and assess any adverse effects associated with each medicament. A total of 75 participants will be randomly assigned to one of the three treatment groups. The study seeks to determine which medicament provides the greatest reduction in postoperative pain and whether probiotics may serve as a safe and effective alternative to commonly used intracanal materials.

Detailed Description Postoperative pain following root canal treatment remains a significant clinical concern, particularly among patients with symptomatic irreversible pulpitis. Although calcium hydroxide is the most widely used intracanal medicament, its limitations-including delayed onset of action, high solubility, and limited antibacterial effectiveness against certain microorganisms-have led to increasing interest in alternative options. Double antibiotic paste, containing metronidazole and ciprofloxacin, has shown strong antimicrobial activity, while probiotics have recently emerged as a potential biotherapeutic alternative with antibacterial and anti-inflammatory properties.

This randomized controlled trial will compare the pain-reducing effectiveness of three intracanal medicaments: calcium hydroxide paste, double antibiotic paste, and a probiotic paste consisting of Lactobacillus rhamnosus GG. Participants aged 18-45 years who are diagnosed with symptomatic irreversible pulpitis, with or without symptomatic apical periodontitis, will be enrolled. After standardized root canal preparation, one of the three medicaments will be placed inside the canal during the first appointment.

Pain will be assessed using a 10-point Visual Analog Scale (VAS) at the following intervals:

Preoperative 12 hours postoperative 24 hours 48 hours 3 days 7 days Any adverse events or additional symptoms-such as swelling, fever, or severe recurrent pain-will be documented. Participants may use prescribed analgesics only if necessary. The medicament will be removed at the second visit after one week, followed by completion of root canal filling.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients falling in ASA 1 category
  • Suffering from symptomatic irreversible pulpitis with range from moderate to severe. In addition to this patient should also have experienced lingering of pain. VAS score will be used to record pain. (Confirmed by clinical and radiographic signs) with or without apical periodontitis.
  • Multirooted teeth (Mandibular 1st and 2nd molars)
  • Age 18-45 year
  • Teeth with a Periapical Index (PAI) score of 1 -3, indicating a healthy periapical status or minimal changes in bone structure not necessarily associated with apical periodontitis, were included in this study.

排除标准

  • Pregnant or lactating mothers
  • Subjects taking chronic pain medications within last 24 hrs.
  • Cracks, complex anatomy, pulp calcification

研究组 & 干预措施

Calcium Hydroxide

Active Comparator

Intrcanal medicament used in RCT

干预措施: Probiotic (Drug)

Double Antibiotic Paste (DAP)

Active Comparator

Intracanal medicament used in RCT

干预措施: Probiotic (Drug)

结局指标

主要结局

Postoperative Pain Intensity

时间窗: Preoperative 12 hours postoperative 24 hours postoperative 48 hours postoperative 3 days postoperative 7 days postoperative

Change in postoperative pain levels following root canal treatment, measured using the Visual Analog Scale (VAS). VAS is a 10-point scale where 0 = no pain and 10 = worst possible pain. Participants will report their pain at multiple time points to evaluate how each intracanal medicament (Calcium Hydroxide, Double Antibiotic Paste, Probiotic Paste) influences pain reduction over time.

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

Zainab Dua

Lecturer

Dow University of Health Sciences

研究点 (1)

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