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比较 Calcipex 和 Metapex 在慢性根尖周炎根管治疗中的抗菌效果:一项随机对照试验研究方案。

Comparison of antimicrobial efficacy of Calcipex and Metapex in endodontic treatment of chronic apical periodontitis: a randomised controlled trial study protocol.

机构信息

Operative Dentistry, Surgery, The Aga Khan University Hospital Main Campus, Karachi, Pakistan

Operative Dentistry, Surgery, The Aga Khan University Hospital Main Campus, Karachi, Pakistan.

出版信息

BMJ Open. 2021 Jul 21;11(7):e048947. doi: 10.1136/bmjopen-2021-048947.

Abstract

INTRODUCTION

Various intracanal medicaments have been used in cases of chronic apical periodontitis for appropriate disinfection of the root canal system to eliminate microbes especially from the inaccessible areas. Calcium hydroxide is the most common intracanal medicament available in various forms, but its effectiveness with or without iodoform using microbial culture is unknown. Therefore, our aim is to compare the antimicrobial efficacy of Calcipex and Metapex in endodontic treatment of teeth presenting with chronic apical periodontitis by assessing the bacterial load reduction.

METHOD AND ANALYSIS

60 single rooted teeth of patients with diagnosis of chronic apical periodontitis will be selected and the canals debrided chemomechanically. The patients will be randomised into two groups: Calcipex and Metapex. The first sample (S1) for bacterial culture will be taken before placement of intracanal medicament and the second sample (S2) will be taken after 7 days, before final obturation from the canal and sent to lab for culture. Colony-forming unit will be evaluated. Paired t-test will be used to assess difference between antimicrobial efficacies within the group of medicaments. Independent sample t-test will be used to assess antimicrobial efficacies between groups. Level of significance will be kept at 0.05.

ETHICS AND DISSEMINATION

Approval from Aga Khan University Hospital Ethical review committee is taken. Findings will be reported according to the Standard Protocol Items for Randomised Trials guidelines. Research findings will be disseminated through annual reports, peer-reviewed journals and conferences.

TRIAL REGISTRATION NUMBER

NCT04336709.

摘要

简介

为了对根管系统进行适当的消毒,以消除微生物,特别是难以触及的区域的微生物,各种根管内药物已被用于慢性根尖周炎的病例。氢氧化钙是最常见的各种形式的根管内药物,但它与碘仿联合使用或不联合使用的效果,微生物培养是未知的。因此,我们的目的是通过评估细菌负荷的减少来比较 Calcipex 和 Metapex 在治疗有慢性根尖周炎的牙齿时的抗菌效果。

方法和分析

将选择 60 颗患有慢性根尖周炎的单根牙,并进行化学机械根管清创。患者将随机分为两组:Calcipex 和 Metapex。将在放置根管内药物之前采集第一个样本(S1)进行细菌培养,第二个样本(S2)将在 7 天后采集,即在根管最终封闭之前,从根管中取出并送到实验室进行培养。将评估集落形成单位。配对 t 检验将用于评估组内药物的抗菌效果差异。独立样本 t 检验将用于评估组间的抗菌效果。显著性水平将保持在 0.05。

伦理与传播

已获得 Aga Khan 大学医院伦理审查委员会的批准。研究结果将根据随机临床试验标准报告进行报告。研究结果将通过年度报告、同行评议期刊和会议进行传播。

试验注册号

NCT04336709。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/62ac/8296811/bfbd8376ed48/bmjopen-2021-048947f01.jpg

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