Assessment of Postoperative Pain After Using Various Intracanal Medication in Patients With Necrotic Pulp

赞助:

合作者:

信息的提供 (责任方):

Nermine Elsayed Abdelsalam Hassan，Cairo University

追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

October 15, 2018

预计主要完成日期

May 18, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Change in post-operative pain[ Time Frame: Intra-appointment and post obturation at 4, 24, 48, 72, 96 hours ]

Numerical (0-10)

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Intracanal Bacterial count reduction[ Time Frame: 1 week ]
Quantification of Colony forming units per milliliter of agar medium (CFU/mL)
Number of analgesic tablets taken by the patient after endodontic treatment[ Time Frame: Within 4 days after the first session and after 1 week from first treatment session ]
Number

描述性信息

简略标题 ^ICMJE

Assessment of Postoperative Pain After Using Various Intracanal Medication in Patients With Necrotic Pulp

正式标题 ^ICMJE

Assessment of Postoperative Pain After Using Silver Nanoparticles With and Without Calcium Hydroxide as an Intracanal Medication in Patients With Necrotic Pulp: (A Randomized Clinical Trial)

简要概况

To assess the Postoperative Pain after using Silver Nanoparticles with and without Calcium Hydroxide as an Intracanal Medication in Patients with necrotic pulp (RCT)

详细说明

When the treatment itself appears to initiate the onset of pain and/or swelling, the result can be very distressing to both the patient and the operator. Patients might even consider postoperative pain and flare-up as a benchmark against which the clinician's skills are measured. Prevalence of postoperative pain or flare-up is, therefore, one of the influencing factors when making a clinical decision. Better management of postoperative pain increases the patients' confidence in dentist's skills and gives positive attitude toward dental profession. In cases with necrotic pulp, the incidence of pain becomes higher, hence testing which intracanal medication is more effective in decreasing the bacteria present within the root canal and subsequently pain is crucial.

研究类型 ^ICMJE

Interventional

研究阶段

Phase 4

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Combination Product: Silver nanoparticle/Calcium hydroxide
Intracanal Medication composed of combined silver nanoparticles with calcium hydroxide
Drug: Silver Nanoparticles in gel form
Intracanal medication composed of silver nanoparticles in gel form
Drug: Calcium Hydroxide Intracanal medication
Calcium hydroxide intracanal medication

研究工具

Active Comparator: AgNP/Ca(OH)
Patients receiving combined Silver nanoparticle/Calcium hydroxide administered as intracanal medication at the first visit after cleaning and shaping
Active Comparator: AgNP
Patients receiving silver nanoparticles in gel form administered as intracanal medication at the first visit after cleaning and shaping
Active Comparator: Ca(OH)
Patients receiving calcium hydroxide intracanal medication at the first visit after cleaning and shaping

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

August 18, 2019

预计主要完成日期

May 18, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Patients who are free from any physical or mental handicapping condition with no underlying systemic disease. - Non-pregnant females - Asymptomatic necrotic mandibular single rooted teeth. - Normal occlusal contact with the opposing teeth. - Patients accepting to participate in the study. Exclusion Criteria: - Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate. - Pregnant women: Avoid radiation exposure, anesthesia, and medication. - If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively might alter their pain perception - Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation Teeth that shows: - Association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain. - Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy. - No restorability: Hopeless tooth. - Vital teeth - Immature teeth - Radiographic evidence of external or internal root resorption. - Any criterion, not mentioned in the inclusion criteria

性别

参与研究的性别:

All

年龄

最小年龄：20 Years ，最大年龄：40 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Yes

责任方

Nermine Elsayed Abdelsalam Hassan，Cairo University

研究赞助商 ^ICMJE

Cairo University

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Nermine Hassan, Msc Cairo University

PRS 账户

Cairo University

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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