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临床试验/NCT05475444
NCT05475444已完成不适用

Modified Surface of PLGA Nanoparticles in Smart Hydrogel: A Randomized Clinical Trial to Establish an Advanced Strategy Against Antibiotic Resistant Infections in Endodontics

British University In Egypt2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Determination of Bacterial count by counting bacterial colonies of the sample

研究概览

简要总结

PLGA nanoparticles coated with Chitosan polymer were prepared and then incorporated in In -situ gel to be injected to root canals of patients suffered from bacterial infection of their endodontics.

详细描述

The Clinical procedures:

  1. First visit Treatment plan was discussed with the patients and their acceptance to participate in the study was obtained through an informed consent.

Coronal restorations and any carious decay were removed, teeth properly restored then rubber dam was applied for isolation. An access cavity was prepared using an appropriate size bur (Bur #3, Veterinary dental equipment, UK) , and the tooth surface was disinfected before entering the root canals using 2.5% sodium hypochlorite, then its effect was inhibited using 5% sodium thiosulphate. The old gutta percha was removed from the coronal two thirds of the root canal using bur #3 without using any solvent. Sterile saline was used for irrigation. Patency was obtained using manual k files #15 (and #10, tooth length was determined using an electronic apex locator (Electronic apex locator J Morita Root ZX, Morita Corporation, Japan). The remaining gutta percha was removed using gradually increasing sizes of manual k files (K- files, Mani, Japan) . Scrubbing of the walls using manual files was done to soak the irrigant (sterile saline) with parts of the bacterial film on the canal walls. Sterile paper point equivalent to the size of largest file reaching the working length was placed for one minute in the canal and located one millimeter away from the tooth length, this represented the first sample for bacteriological assessment (S1) then paper point was placed in 1ml sterile medium. Complete cleaning and shaping of the canal was done using 15 ml of 2.5% sodium hypchlorite as an irrigant with a side vented needle of gauge 27, placed one millimeter from the working length and manual k type files, the master apical file was determined according to each case, where its size was increased 3 times more than the initial file with obtained white dentine chips as well. After complete cleaning and shaping, the action of sodium hypochlorite was inhibited by using 10 ml of 5% sodium thiosulphate. Sodium thiosulphate was flushed from the canal using 5 ml sterile saline. A sterile paper point equivalent to the size of master apical file was placed for one minute in the canal, one millimeter away from the working length to soak the fluid and this represented the second sample for bacteriological assessment (S2), afterwards, paper point is placed in 1ml sterile medium, then the patients were randomly allocated according to the use of an intracanal medications to the five groups for 7 days. Finally, a cotton pellet and temporary filling (Orafill-G) was applied under complete aseptic conditions 2. Second visit

• Assessment of the clinical signs and symptoms was done. 3. Clinical criteria for healing:

  1. No pain with percussion 2. No pain with palpation 3. Tooth asymptomatic and functional If the patient showed these clinical findings, root canals were obturated. If the patient had all or one of them, cleaning, shaping and medication steps were repeated and the patient re-scheduled for another visit after 7 days. If the patient was asymptomatic and the tooth was functional, then a temporary filling was removed under rubber dam isolation. Twenty ml of sterile saline was used to remove the intracanal medicaments until it got out clear from the canal then sterile paper point was placed in the canal one millimeter away from the working length to take the last sample (S3), paper point was placed in 1ml sterile medium, finally master cone adjustment and obturation were done.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Root canal filled single rooted teeth with post treatment disease manifested by one or more of the following signs and symptoms:
  • History of recurrent acute and/or chronic periapical abscess
  • Pain on palpation and/or percussion at least after one month of previous procedure
  • Radiographic evidence of bone loss either as a new developing lesion or an increase in the size of a pre-existing one.

排除标准

  • Teeth that were badly broken down indicated for extraction or with difficult isolation
  • Immuno-compromised patients.
  • Patients with history of taking antibiotics orally.
  • Periodontally affected teeth.

结局指标

主要结局

Determination of Bacterial count by counting bacterial colonies of the sample

时间窗: One week

Bacterial count was expected to be decreased by counting bacterial colonies of the sample after treatment and comparing with control without treatment

次要结局

  • Determination of the Biofilm inhibition using crystal violet and microplate reader(one week)

研究者

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

Mona Gamal Mohamed Afifi Arafa

Associate Professor

British University In Egypt

研究点 (2)

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