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临床试验/NCT07800403
NCT07800403招募中不适用

Efficacy of a Novel Nanoparticle -Augmented Disinfection Protocol in the Non -Surgical Retreatment of Maxillary Anterior Teeth in Type II Diabetic Patients: A Randomized Clinical Trial

Minia University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2026年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
28
试验地点
1
主要终点
Post Operative Pain

研究概览

简要总结

The ultimate biological aim of endodontic therapy is to either prevent or heal apical periodontitis. Root canal treatment can fail for various reasons, such as persistent infection, missing canals, ledges, canal transportation, instrument separation, and perforation.

Post-treatment apical periodontitis is an inflammatory response in the tissues surrounding the root tip, triggered by either lingering bacteria from the initial procedure or a new, secondary infection within the canal system. Statistically, this condition affects roughly 5% to 20% of cases where apical periodontitis was present before the initial treatment.

详细描述

The primary objective of endodontic therapy is rigorous infection control, achieved through the chemo-mechanical preparation of the root canal system. While mechanical filing shapes the canal, it is physically impossible for instruments to reach every internal surface.5 Consequently, chemical irrigation is the only method available to disinfect "untouched" anatomical complexities-such as isthmuses, fins, and large lateral canals. These hidden areas often harbor tissue debris and resilient biofilms that must be dissolved or neutralized chemically to ensure long-term clinical success.

While traditional irrigants like Sodium Hypochlorite (NaOCl) and EDTA remain the clinical gold standards, the field is shifting toward natural alternatives. Chitosan and Aloe Vera have recently emerged as effective herbal options, with Chitosan gaining particular attention as a promising final irrigation solution. Derived from natural sources, Chitosan is highly accessible and cost-effective. It offers a unique combination of biological and chemical benefits that address the limitations of traditional synthetic chemicals.

Chitosan, and specifically Chitosan Nanoparticles (CNPs), exhibits potent antimicrobial activity against a wide spectrum of both Gram-positive and Gram-negative bacteria. Research indicates that CNPs are highly effective at disrupting biofilms by preventing bacteria from adhering to the canal surfaces, effectively halting the development of complex microbial communities. The primary antibacterial action of Chitosan is derived from its polycationic (positively charged) nature. This charge creates a fatal attraction to the negatively charged surfaces of bacterial cells, leading to two major destructive effects.

Activation of irrigating solution by techniques as passive ultrasonic irrigation (PUI), enhances its efficacy and dynamic flow, and improves its antibacterial property and clinical outcomes.

Diabetes mellitus (DM) is defined as a multisystem complex metabolic disease that affects around 9% of the adult population. DM has two types, type 2 DM (T2DM) is caused by decreased cellular sensitivity of beta cells in islets of Langerhans of the pancreas to insulin which is referred as "insulin resistance". In general DM has an effect on the immune system that could be seen as a delay in wound healing with increased susceptibility to chronic inflammation and impaired tissue repair10.

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

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

入选标准

  • Diabetic patients type II of either gender aged from 18-40 years
  • Permanent mature Maxillary anterior teeth having a baseline periapical lesion (PAI score ≥3).

排除标准

  • Immuno-compromised patients.
  • Pregnant women and smokers.
  • Patients with a history of antibiotic or analgesics intake within the few days before the endodontic treatment.
  • Teeth with root fractures or perforations.
  • Teeth with lesions connected to adjacent teeth.

研究组 & 干预措施

Non- surgical retreatment Novel Nanoparticle (NSRN)

Active Comparator

About 14 cases will be irrigated with 5 ml of Novel Nanoparticle -Augmented irrigation placed in the root canal and activated passively with woodpecker ultrasonic (Guilin Woodpecker Medical Instrument Co., Ltd., China) for 3 cycle 20 seconds.

干预措施: Novel Nanoparticle (Procedure)

Non -surgical root canal retreatment (NSRC)

Active Comparator

About 14 cases will be irrigated with 5 ml of (2.5%) NaOCl placed in the root canal and activated passively with woodpecker ultrasonic scaler (Guilin Woodpecker Medical Instrument Co., Ltd., China) for 3 cycle 20 seconds.

干预措施: Novel Nanoparticle (Procedure)

结局指标

主要结局

Post Operative Pain

时间窗: from 24 hours to 72 hours after the procedures

Evaluation of the cases from the pain after the procedures by using point numeric rating scale by another operator at 24, 48 and 72-hours.

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ebthal Hamada Saleh

Assistant lecturer at Endodontics Department,Faculty of Dentistry

Minia University

研究点 (1)

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