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临床试验/NCT06453304
NCT06453304招募中2 期

Clinical Investigation of the Effectiveness of Glycyrrhizin as Intracanal Medication in Root Canal Disinfection and Inflammatory Cytokines

Mansoura University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年3月20日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
36
试验地点
1
主要终点
counting the number of colonies forming units of bacterial cells

研究概览

简要总结

The objective of this study is to investigate "clinically" the effectiveness of Glycyrrhizin based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide Ca(OH)2 and Ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.

详细描述

Periodontitis is a dynamic inflammatory process located at the periapical region, the type of immune-inflammatory response to periapical periodontitis is determined by a network of chemical mediators produced by immune cells in response to the stimulus caused by the action of microorganisms and/or virulence factors. This may result in damage to the tissues and in the development of endodontic signs and symptoms (1-3).

In infected root canals, the destruction of periapical tissues is mediated by tumor necrotizing factor (TNF-α) and interleukin-1β (IL-1β) that appears to be directly related to high levels of infectious content present in the root canal (4). Arachidonic acid metabolism plays a key role in many inflammatory diseases, one of its products is the prostaglandin E2 (PGE2) which has been also shown to potentially stimulate bone resorption and to inhibit reparative bone formation in vitro and in vivo (5). Particularly, IL-1β, TNF-α, and PGE2 have been detected in periapical tissues (6-9), being considered as an important inflammatory biomarker in the periapical disease (1, 2, 5, 7, 10).

To identify a specific inflammatory mediator as a diagnostic marker of disease status, the mediator should not only be present or elevated in disease and absent or low in health, but it should also longitudinally increase during active disease progression and subside following therapy (5).

Although instrumentation may be assumed to be of greater importance in the clinical practice, the use of intracanal medication has been proven to optimize the root canal disinfection (11-14). As root canal medicaments can come in direct contact with periapical tissues, in addition to having good antibacterial ability and being biocompatible, so a wide variety of intracanal medications have been proposed. In selecting root canal medicaments, it is necessary to consider their therapeutic benefits against their potential cytotoxic effects. Ideal root canal medicaments should have strong antibacterial properties and minimal cytotoxic effect on the host tissues (11-16).

Calcium hydroxide (Ca(OH)2) has been used extensively in dentistry since the 1920s (17). Today, it is still the most commonly used endodontic medicament throughout the world(18).Ca(OH)2 also inactivates lipopolysaccharide so it can assist in periapical tissue repair (19).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Single-rooted with pulp necrosis and apical periodontitis.

排除标准

  • Receiving antibiotic treatment within the preceding 3 months.
  • Reporting systemic disease.
  • Teeth that could not be isolated with rubber dam.
  • Teeth with periodontal pockets deeper than 3 mm.

研究组 & 干预措施

Calcium Hydroxide

Active Comparator

干预措施: Calcium Hydroxide (Drug)

Leddermix

Active Comparator

干预措施: Leddermix (Drug)

Glycirrhizin

Active Comparator

干预措施: Glycirrhizin (Drug)

结局指标

主要结局

counting the number of colonies forming units of bacterial cells

时间窗: up to 7 months

Microbiology cell culturing (manual counting technique to the bacterial cells)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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