Effect of Vachellia Nilotica Versus Sodium Hypochlorite as Root Canal Irrigant on Postoperative Pain and Bacterial Load Reduction in Mandibular Premolar Teeth With Necrotic Pulp
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 46
- 主要终点
- post operative pain.
研究概览
简要总结
The aim of this study is to assess the effect of V. nilotica extract solution versus 2.5% NaOCl on the intensity of postoperative pain and the amount of bacterial load reduction.
详细描述
Clinical compare the effect of V. nilotica extract solution versus 2.5% NaOCl on the intensity of postoperative pain and the amount of bacterial load reduction when used as root canal irrigant in necrotic pulp. The post operative pain will be recorded using Numerical rating scale, and the bacterial load reduction will be measured by Bacterial counting using agar culture technique.
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
- Double (Participant, Outcomes Assessor)
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
- •Systemically healthy patient (ASA I, II).
- •Age between 20 and 40 years.
- •Male or female.
- •Patient who is able to sign and comprehend the pain scale (committed patient).
- •Mandibular single rooted premolars having the following criteria:
- •With single root canal.
- •Diagnosed clinically with pulp necrosis.
- •Absence of spontaneous pulpal pain.
- •Positive pain on percussion denoting apical periodontitis.
- •Slight widening of periodontal space or peri-apical radiolucency smaller than 3 mm (0-2mm).
排除标准
- •Medically compromised patients (ASA III or IV).
- •Teeth with:
- •Immature roots.
- •Vital pulp tissues.
- •Association with swelling.
- •Acute peri-apical abscess or acute exacerbation of a chronic abscess.
- •Mobility Grade II or III.
- •Previously accessed or endodontically treated.
- •Deep periodontal pockets more than 4 mm.
- •Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
- •Patients who could not interpret the NRS.
- •Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women will be also excluded.
- •History of intolerance to NSAIDs.
研究组 & 干预措施
Experimental group
in this group the teeth will be irrigated with 10% V. Nelotica (Herbal irrigant)
干预措施: Vachellia Nelotica (Other)
Control group
in this group the teeth will be irrigated with 2.5% Sodium Hypochlorite (gold standard)
干预措施: sodium hypochlorite (Other)
结局指标
主要结局
post operative pain.
时间窗: At 6, 12, 24, and 48 hours postoperatively (post instrumentation and post obturation)
non=0, mild=1-3, moderate4-6, sever=7-10. Measured and reported by Numerical Rating Scale (NRS). Minimum value=0, maximum value=10, the higher score or value mean a worse outcome.
次要结局
- Bacterial load reduction(1 hour. First sample (S1) will be taken pre-intervention (before chemo-mechanical preparation) and the second sample (S2) will be taken immediately after the intervention (after completion of chemo-mechanical preparation) on the same visit.)
研究者
Gozlan Fouad Saad Mohamed
Principal Investigator, master's degree student, Endodontic Department, Cairo University
Cairo University