Comparative Evaluation of Propolis and Sodium Hypochlorite as Endodontic Irrigants on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in post-operative pain intensity on visual analogue scale(0-10)
研究概览
简要总结
The goal of this clinical trial is to compare propolis and sodium hypochlorite as endodontic irrigants in patients presenting with symptomatic irreversible pulpitis.
. The main question it aims to answer is:
• if there is any analgesic effects of 20% Propolis compared with 5.25% NaOCl on the intensity of post-operative pain in patients with symptomatic irreversible pulpitis using VAS pain score. Participants will undergo root canal treatment of their teeth using either 20% propolis solution or 5.25% NaOCl in their first visit of a multi-visit root canal treatment.
Researchers will compare 20% Propolis and 5.25% NaOCl to see reduction in Intensity of Post-Operative Pain using visual analogue scale over 72 hour duration.
详细描述
Sodium hypochlorite as an endodontic irrigant, poses problems of toxicity. Additionally, its unfavorable odor, taste, failure to remove the smear layer, and proteolytic effect have deleterious effects on the dentine, creating unfavorable structural and mechanical alterations . To get beyond NaOCl limits and adverse effects, it is necessary to look for a biocompatible, equally effective, and dentine friendly irrigant with greater patient acceptance in taste and odor.
The literature lacks an in-vivo study that investigates the anti-inflammatory with analgesic characteristics of Propolis on post-endodontic pain as an irrigant, in patients with symptomatic irreversible pulpitis. This research will endeavor to fill this gap in literature.
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, Outcomes Assessor)
盲法说明
Participants will not be aware of their interventional group. A proforma and pain intensity scale will be provided to the patient by an intern not involved in the study, to be completed at 24, 48, and 72 hours following the procedure to assess post-operative pain. this proforma will be collected and assessed by the intern.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA-I and II individuals who are between the ages of 18 and 60 years.
- •Patients with mandibular and maxillary premolars who have been diagnosed with symptomatic irreversible pulpitis (with either a normal periapex or symptomatic apical periodontitis).
- •Patients who score moderate to severe (4-10) on a preoperative visual analogue scale (VAS=1-10)
排除标准
- •Patients suffering from severe pain because of traumatic occlusion.
- •Teeth with extensive damage, calcified canals, periapical radiolucency, root resorption, and an open apex.
- •Patients with compromised medical condition (ASA-III and above)
- •Patients who are unable to communicate effectively in either Urdu or English.
- •Pregnant and lactating ladies
- •Patients who are allergic to honey or bee pollen.
研究组 & 干预措施
Sodium Hypochlorite
5.25% sodium hypochlorite is the gold standard endodontic irrigant. Other Name: NaOCl
干预措施: Sodium hypochlorite 5.25% (Drug)
Propolis
Hydroalcoholic 20% propolis will be used as an endodontic irrigant. Other Name: Bee glue
干预措施: Propolis 20% (Drug)
结局指标
主要结局
Change in post-operative pain intensity on visual analogue scale(0-10)
时间窗: 24 hours, 48 hours and 72 hours
Self recorded by patient and then assessed by an intern on a visual analogue scale of 0-10 with 0 being no pain , 10 being worst pain
次要结局
- Need of rescue medicine in both groups(within first 24 hours)
研究者
Tayyaba Tahira
Lecturer
Dow University of Health Sciences