NCT07495605尚未招募不适用
Effect of 1% Melatonin Gel Versus Calcium Hydroxide as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp: A Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Intensity of postoperative pain
研究概览
简要总结
To compare the effect of 1% melatonin gel versus calcium hydroxide as intra canal medication in necrotic mandibular premolars on:
- Intensity of postoperative pain.
- Bacterial load reduction.
- Periapical (MMP-9) level.
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
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-50 years old.
- •Males and females.
- •Healthy patients categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II), with no underlying allergies.
- •Single-rooted mandibular premolar teeth, having single root canal: diagnosed clinically with pulp necrosis.
- •Patients accepting to participate in the trial.
- •Patients who can understand pain scale (Appendix I) and can sign the informed consent (Appendix II).
排除标准
- •Medically compromised patients having significant systemic disorders (ASA III or IV).
- •Pregnant females.
- •If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
- •Teeth with multiple canals.
- •Teeth that show association with acute periapical abscess or swelling.
- •Teeth with vital pulp.
- •Non-restorable teeth or teeth that could not be adequately isolated with a rubber dam.
- •Immature teeth.
- •Teeth with greater than grade I mobility or pocket depth greater than 4 mm.
- •Teeth showing radiographic evidence of external or internal root resorption, vertical root fracture, perforation or calcification.
- •Patients with two or more adjacent teeth requiring endodontic treatment.
- •Patients reporting bruxism, clenching or TMJ problems.
- •Teeth with previous endodontic treatment.
- •Inability to perceive the given instructions.
结局指标
主要结局
Intensity of postoperative pain
时间窗: up to 48 hours
Intensity of postoperative pain will be measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation
次要结局
- Bacterial load reduction(intraoperative)
- Periapical MMP-9 level(intraoperative)
研究者
Alaa Ibrahim Ibrahim Ghazy Mekhimar
Dr
Cairo University
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