Effect of Propolis Paste as Intracanal Medicament on Post-Endodontic Pain: a Double-Blind Randomized Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Intensity Measure: Visual Analogue Pain Scale
研究概览
简要总结
This study evaluates the role of propolis paste as compared to calcium hydroxide (when used as intracanal medication) in prevention and treatment of pain after root canal treatment in necrotic (infected) teeth. Half of the participants will receive calcium hydroxide, while the other half will receive propolis.
详细描述
Propolis is a developing herbal medicament used in various aspects on dentistry. it is extremely biocompatible; has flavanoids; which acts as anti-inflammatory and antimicrobial components.
Calcium hydroxide is a synthetic medication which is antibacterial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single rooted Necrotic teeth with symptomatic or asymptomatic periapical periodontitis having periapical widening or radiolucency without bone expansion (PAI index 2, 3 and 4).
- •Teeth with favorable root morphology.
- •Teeth with closed apex.
排除标准
- •Teeth with PAI index 1 and
- •Patients who are on antibiotics.
- •Patient with recent trauma to the jaw.
- •Teeth with open apex
- •Multi-rooted teeth.
- •Vital teeth.
- •Non-restorable teeth.
- •Unfavorable root morphology (severely curved, dilacerated, severely sclerosed or obliterated).
- •Teeth associated with soft tissue abscess or swelling.
- •Teeth with external or internal root resorption
- •Re-treatment cases.
- •Periodontally compromised teeth (like mobile teeth and teeth with excessive bone loss).
- •Teeth requiring endodontic surgery.
- •Teeth requiring non-surgical endodontic treatment of multiple teeth in the same or opposing quadrant.
- •Medically compromised patients (ASA-III and above), patients with special communication needs or who doesn't understand Urdu or English language.
- •Patients allergic to bee pollen or honey products.
研究组 & 干预措施
Control Group or Group I or Calcium hydroxide Group
干预措施: Calcium Hydroxide (Drug)
Experimental Group or Group II or Propolis Group
干预措施: Propolis (Drug)
结局指标
主要结局
Pain Intensity Measure: Visual Analogue Pain Scale
时间窗: 4 hours, 12 hours, day 2, day 3 and day 4
Self recorded pain intensity by the patients at 4 hours, 12 hours, day 2, day 3 and day 4 after root canal preparation and intracanal medicament insertion (first visit). Pain intensity recorded on a Visual Analogue Scale from 0 to 100. Patients who experience no or mild pain; and do not require analgesic will record their pain intensity from 0 to 24. Patients who experience moderate pain; and require Over-the-counter analgesic will record pain intensity from 25 to 49. Patients who experience severe pain; and require use of codeine containing medicine will record their pain intensity from 50 to 74. Patients who experience extreme pain, and no medicine is able to relieve their pain will record pain intensity from 75 to 100. lower pain score (intensity) is a better outcome as compared to higher pain intensity (score)
次要结局
- Acute Increase in Pain Score (Acute Exacerbation of Pain)(4 hours, 12 hours, day 2, day 3, and day 4)
- Difference of Pain Score Between Different Time Intervals(4 hours, 12 hours, day 2, day 3, and day 4)
研究者
Juzer Shabbir Saifee
Principal Investigator
Dow University of Health Sciences