NCT05666089尚未招募早期 1 期
Effect of N-acetylcysteine Versus Calcium Hydroxide Used as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Levels of MMP -9 in Periapical Fluids in Patients With Necrotic Pulp: A Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intensity of postoperative pain
研究概览
简要总结
To compare the effect of N-acetylcysteine versus calcium hydroxide as intra canal medication on:
- Intensity of postoperative pain.
- Bacterial load reduction.
- levels of MMP -9 in Periapical Fluids.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are free from any physical or mental handicapping condition.
- •Males & Females with
- •Mandibular single rooted permanent premolar teeth.
- •Absence of spontaneous pain.
- •Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2*2 mm radiographically.
- •Patients' acceptance to participate in the trial.
- •Patients who can understand pain scale and can sign the informed consent (Appendix I)
排除标准
- •Medically compromised patients.
- •Pregnant women
- •Patients undergoing previous endodontic treatment or analgesics and/or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
- •Patients reporting bruxism or clenching.
- •Teeth that show association with acute periapical abscess and swelling.
- •Greater than grade I mobility or pocket depth greater than 5mm.
- •Non-restorable teeth or teeth that could not be adequately isolated with a rubber dam
- •Teeth with vital pulp.
- •Immature teeth.
- •Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
研究组 & 干预措施
N-acetylcysteine
Experimental
intracanal medication of NAC paste
干预措施: N-acetyl cysteine (Drug)
Calcium hydroxide
Active Comparator
intracanal medication of Ca(OH)2 paste
干预措施: Calcium hydroxide (Drug)
结局指标
主要结局
Intensity of postoperative pain
时间窗: 48 hours post-obturation
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
次要结局
- Bacterial load reduction(Sample 3 (S3): after 2 weeks intracanal medicament placement (pre-obturation))
- Periapical MMP-9 level(after 2 weeks at 2nd visit (pre-obturation).)
研究者
Safwa Essam Mohammed Ahmed Abd el-glil
Assistant lecturer
Cairo University
研究点 (1)
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