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临床试验/NCT03690960
NCT03690960Unknown不适用

Evaluation of the Antimicrobial Effect of Pre-synthesized Novel Antibiotic Electrospun Nanofibers as an Intracanal Delivery Strategy for Regenerative Endodontics A Randomized Clinical Trial

Cairo University0 个研究点目标入组 30 人开始时间: 2018年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
主要终点
antimicrobial effect

研究概览

简要总结

The treatment for immature teeth with pulp necrosis can be carried out through apexification or regenerative endodontics procedures including platelet rich plasma (PRP), platelet rich fibrin (PRF) and injectable PRF, these techniques used alone or in combination. Revascularization therapy carries on more advantages than apexification, such as inducing root-end development and reinforcement. However, apical repair will not happen in the presence of inflamed and infected tissue.the aim of this study is to evaluate the antimicrobial effect of pre-synthesized novel antibiotic loaded electrospun nanofibers used in patients with immature necrotic teeth.

详细描述

Title: Evaluation of the Antimicrobial Effect of Pre-synthesized Novel Antibiotic Electrospun Nanofibers as an Intracanal Delivery Strategy for Regenerative Endodontics - A Randomized Clinical Trial

Rationale Regenerative endodontics technique outcome depends on microbial elimination because apical repair will not happen in the presence of infected tissues. It is well established that bacteria are essential for the development of pulpal and periapical pathosis. Eradication or control of bacteria may provide optimal treatment outcome. However, elimination of bacteria from infected root canal systems is challenging. Numerous measures have been described to reduce the number of bacteria in the root canal system, including the use of various instrumentation techniques, irrigation regimens and intra-canal medicaments. There is no definitive evidence in the literature that all these measures result in a bacteria-free root canal system.

Therefore additional methods such as the use of intra-canal medicaments are required in order to maximize disinfection of root canal system and kill as many bacteria as possible. Antibiotics have been proposed as intracanal medicament but any single antibiotic is unlikely effective to sterilize diverse flora in root canal infection.

Recently, triple antibiotic mixture (TAP) has been reported for successful disinfection of infected root dentine. This mixture consist of ciprofloxacin (CIP), metronidazole (MET) and minocycline (MINO) which consistently sterilize bacteria of infected dentine and infected pulps . Specifically, MET is a bactericidal imidazole that is highly effective against obligate anaerobic bacteria, CIP is a bactericidal broad-spectrum synthetic quinolone and MINO is a bacteriostatic broad-spectrum tetracycline.

However, as minocycline binds to dentin and causes tooth discoloration, it is recommended to remove minocycline from TAP and use only MET and CIP, or to use modified TAPs containing cefaclor or clindamycin (CLIN). CLIN is a bacteriostatic lincosamide known for its efficacy against a broad spectrum of endodontic bacteria.

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
7 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Maxillary or mandibular single-root tooth with:
  • Non-vital response of pulp tissue.
  • Immature root.
  • Asymptomatic patients.

排除标准

  • Patients allergic to metronidazole, ciprofloxacin, or clindamycin to avoid allergic reaction in the intervention group.
  • Patients who received antibiotics in the past 3 months.
  • Vital cases or previously accessed teeth.
  • Teeth with unfavorable conditions for rubber-dam application.
  • Patients with systemic and immune-compromising disease as they have impaired healing

研究组 & 干预措施

electrospun TAP nanofibers

Experimental

Revascularization procedure with Electrospun TAP nanofibers as as an intracanal medicament for immature necrotic teeth

干预措施: electrospun TAP nanofibers (Procedure)

modified TAP paste

Active Comparator

Revascularization procedure with modified TAP paste as an intracanal medicament for immature necrotic teeth

干预措施: modified TAP paste (Procedure)

结局指标

主要结局

antimicrobial effect

时间窗: 2-3 weeks

number of colony forming units of bacteria after using the intracanal medicaments

次要结局

  • morphology of nanofibers(1 week)

研究者

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

sara Gamal Ahmed

Ass.lecturer of endodotics

Cairo University

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