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临床试验/NCT03724266
NCT03724266Unknown不适用

Effect of Using Nanochitosan Versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing

Cairo University0 个研究点目标入组 60 人开始时间: 2018年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
60
主要终点
change in postoperative pain after intervention of chitosan: NRS

研究概览

简要总结

Effect of Using Nanochitosan versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing

详细描述

PICO approach P (population): maxillary anterior teeth having necrotic pulp with symptomatic apical periodontitis with evidence of apical radiolucency (minimum size 2 mm x 2 mm).

I (intervention):0.2% nanochitosan as intracanal medication. C (control): calcium hydroxide paste intracanal medication.

O (outcome):

Primary outcome: postoperative pain at time interval 4, 12, 24, 48, 72 hours

Secondary outcome:

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)

盲法说明

participants should be blinded

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

chitosan

Experimental

chitosan as intracanal medication 0.2% in form of gel

干预措施: Chitosan (Drug)

calcium hydroxide

Active Comparator

intracanal medication

干预措施: Calcium Hydroxide (Drug)

结局指标

主要结局

change in postoperative pain after intervention of chitosan: NRS

时间窗: 4,12,24,27 hours

pain assessed by numerical rating scale, pain will be assessed using a numerical rating scale (NRS) which is proven to be a simple, valid, and a reliable pain measurement tool. The NRS consists of a series of numbers from zero to 10 with the end-points representing the extremes of pain as "no pain" and "the worst possible pain". Patients will rank their pain level by making a mark on the number they thought it represented their pain. The pain intensity is assigned into four categorical scores: 1, no pain (score 0); 2, mild (scores 1-3); 3, moderate (scores 4-6); 4, severe (scores 7-10). Pain is evaluated preoperatively and postoperatively after the initial visit at 4, 12, 24, 48, 72 hours

次要结局

  • change in healing of apical periodontitis(3,6,12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ahmed abdelmonam abd elmougoud

Phd student, principle investigator

Cairo University

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