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临床试验 NCT07388888 (Ca(OH)2 - CNPs) 针对Pulp Necrosis目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。 | ||
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Antibacterial Effect of Two Different Intracanal Medicaments and Their Effect on Post-operative Pain (Ca(OH)2 - CNPs) IV期 52
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临床试验NCT07388888 (Ca(OH)2 - CNPs)旨在研究治疗,主要针对Pulp Necrosis。这是一项IV期 干预性研究试验,当前状态为尚未招募。试验尚未开始,计划于2026年2月1日开始,预计招募52名患者。该研究由艾因夏姆斯大学主导,计划于2027年4月1日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2026年2月5日。
简要概括
Evaluation of antibacterial effect of two different intracanal medicaments on bacterial load in infected mature permanent teeth and their effect on post-operative pain level.
详细描述
Microorganisms within the root canal system exist as complex, multispecies biofilms made up of microcolonies that adhere permanently to each other and to surfaces such as dentin. The characteristics of these biofilms-including their composition, thickness, and location-vary according to environmental conditions like nutrient availability, pH, oxygen levels, and exposure to the oral cavity. Endodontic treatment aims t...显示更多
官方标题
Comparative Evaluation of Anti-Bacterial Efficacy Of Two Different Intracanal-Medicaments and Their Effect On Post-Operative Pain Level (A Randomized Clinical Trial)
疾病
Pulp Necrosis其他研究标识符
- Ca(OH)2 - CNPs
- FDASU-Rec IM012482
NCT编号
实际开始日期
2026-02
最近更新发布
2026-02-05
预计完成日期
2027-04
计划入组人数
52
研究类型
干预性研究
试验分期 (阶段)
IV期
试验状态
尚未招募
关键词
effect of two intracanal medicaments on bacterial load and post operative pain level in mature teeth with necrotic pulp
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照calcium hydroxide (Ca(OH)2) intracanal medicament in infected root canal | Calcium Hydroxide (Ca(OH)2) Non setting calcium hydroxide intracanal medicament is injected through the root canal for two weeks |
实验性Chitosan nano particles (CNPs) intracanal medication in infected root canal | chitosan nanoparticles gel Nano chitosan gel is injected through the root canal as an intracanal medicament for two weeks |
无干预control | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Bacterial load. | Samples will be collected from the infected root canal before and after injection of intracanal medicaments then bacterial colonies will be counted for colony forming units per milliliter (CFU/ml) to assess the effect of the intracanal medicaments used. | two weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Visual Analogue Scale (VAS) to measure post operative pain level. | the patient is given a 10 cm sheet to mark their pain level where (0) represents no pain and (10) the worst pain. | 12 hours, 24 hours, 48 hours, 72 hours. |
参与助手
资格标准
适龄参与研究
成人
最低年龄要求
18 Years
适龄性别
全部
- free medical history,
- mature infected permanent single rooted teeth diagnosed clinically and radiographically with adequate coronal structure for proper isolation, temporization and restoration.
- Patients who are not included in the age range of the study or having a systemic condition.
- Teeth with severe fractures or resorption or periodontally compromised.
研究责任方
Rana mohamed mustafa nagdy, 主要研究者, Dentist, Ain Shams University
研究中心联系人
联系人: Rana M Nagdy, MSc, +201006224327, [email protected]
1 位于 1 个国家/地区的研究中心
Faculty of Dentistry Ain Shams University, Cairo, Egypt