NCT07101029尚未招募1 期
Effect of Bio-C Temp Versus Calcium Hydroxide as an Intracanal Dressing on Postoperative Pain Intensity and Periapical MMP-9 Level 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
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Intensity of post-operative pain
研究概览
简要总结
To compare the effect of Bio-C Temp Bioceramic intracanal dressing versus calcium hydroxide as intracanal medicaments on:
- Intensity of postoperative pain
- 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 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.
- •Absence of spontaneous pulpal pain.
- •Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2*2 mm radiographically.
- •Patients accepting to participate in the trial.
- •Patients who can understand pain scale and can sign the informed consent
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. 9
- •Teeth that show association with acute periapical abscess, swelling or fistulous tract.
- •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.
- •Inability to perceive the given instructions.
研究组 & 干预措施
Bio-C Temp
Experimental
This group will Receive Bio-C Temp Bioceramic paste as intracanal dressing
干预措施: Bio-C Temp Intracanal Medication (Drug)
Calcium Hydroxide
Active Comparator
This group will Receive Calcium Hydroxide paste as intracanal dressing
干预措施: Calcium Hydroxide Intracanal medication (Drug)
结局指标
主要结局
Intensity of post-operative pain
时间窗: 48 hours post-obturation
Intensity of post-operative pain as measured by Numerical Rating Scale (NRS)
次要结局
- Periapical MMP-9 level(at the first visit post- instrumentation)
- Periapical MMP-9 Level(After 1 week at the second visit (pre-obturation))
研究者
Mennatallah Alaa El-Dien Mohamed
Assisstant Lecturer
Cairo University
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