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临床试验/NCT05277246
NCT05277246Unknown不适用

Effect of Using Different Concentrations of NaOCI on IL-8 Level During Endodontic Treatment of Teeth With Irreversible Pulpitis

Yuzuncu Yıl University0 个研究点目标入组 84 人开始时间: 2022年3月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
84
主要终点
IL-8 Level

研究概览

简要总结

The objective is to compare various concentrations of NAOCL during Root canal treatment and their effect on IL-8 at the gingival crevicular fluid. Despite the current advancement of beneficial endodontic diagnostic methods, such as pulp sensitivity tests and periapical radiographs, clinical outcomes do not always correspond with the arrangement of the histological condition of the pulp. At this point, the need for other ways to help diagnose pathological pulpal disease has arisen. This situation has influenced researchers to use molecular evaluation as an alternative route in endodontic diagnosis. Biomarkers, functional at the cellular and molecular level, are crucial elements within the pathological process. Detection of molecular markers is considered an ancillary method for diagnosing the pathological condition of the pulp tissue.An increase in inflammatory cells in the carious or traumatized dentinal pulp complex has been reported. In the presence of bacteria, immune cells produce interleukin-6 (IL6), interleukin-8 (CXCL8), and tumor necrosis factor-alpha (TNF) in the pulp. Interleukin-8 is frequently expressed in endothelial cells of inflamed pulp and rarely in the normal pulp. Karapanou et al. (2008) revealed that interleukin-8 was more greatly released in teeth with irreversible pulpitis than in the control group in a research in which gingival crevicular fluid with acute pulpitis was analyzed. the pulp tissue and gingival crevicular fluid of teeth with symptomatic irreversible pulpitis were dramatically augmented by these indicators compared with healthy teeth. Furthermore, they concluded that the levels of NKA, SP, IL8, and MMP8 in the gingival crevicular fluid decreased one week after endodontic treatment of teeth with pulpitis. Subsequently, it has been reported that patients with symptomatic irreversible pulpitis with high initial pain scores have higher levels of SP, IL8, and MMP8 in the pulp tissue samples than those with low pain scores.It is recommended to use NaOCl concentration between 0.5% and 5.25% as an irrigation solution in root canal treatment (6). The effectiveness of NaOCl increases with increasing concentration, but its toxicity is known to be proportional to concentration.

Therefore, there is no consensus on the optimal concentration of NaOCL. When articles were reviewed, it was found that inflammation of the pulp and biomarker levels are correlated. For this reason, we believe that whether or not NaOCl solution at various concentrations causes inflammation can be analyzed by the level of IL-8. Upon review of the literature, it was found that no studies investigated the influence of NaOCl solution on biomarkers in the gingival crevicular fluid. The research described below contributes to the literature on the optimal concentration of NaOCl to use.

详细描述

The study is to be carried out in 84 medically fit patients, aged 18-50 years, who were diagnosed and followed up at Van Yüzüncü Yıl University, Faculty of Dentistry, Department of Endodontics, (The number of patients was determined according to "power analysis.") Lower first and second molars (36,37,46,47) diagnosed with irreversible pulpitis will be included in the study as an experimental group.

As the control group, the contralateral teeth of the related teeth will be evaluated. Patients with periapical lesions and open apex teeth will not be included in the study group. Before treatment, patients will be asked to determine their pain level according to a 0-10 VAS scale, and this value will be recorded for comparison with post-treatment. Teeth (experimental and control ) to be sampled from the gingival crevicular fluid will be isolated with a cotton roll and saliva ejector.

The supragingival plaque will be carefully removed using a curette. The teeth to be inspected will be dried with air for 10 seconds. A Periopaper strip (Oraflow, Smithtown, NY, USA) will be placed in the interproximal mesial gingival sulcus of the affected tooth until slight resistance is confronted and is removed after 1 min. Samples contaminated with blood or saliva will not be involved in the study. All collected periopaper strips will be placed in 1.5 ml Eppendorf tubes (Labosel, Istanbul, Turkey) and stored at -80 ° C until analysis.

After applying 2ml local anesthesia (Maxicaine DS strong (Vem, İstanbul, Türkiye)), the access cavity will be opened with diamond bur. The working length will be determined using the apex locator (DentsplyMaillefer, UK) and the radiographic x-ray by placing a K file #15 (Mani Inc, Tochigi, Japan) into the root canals until the apical constriction.

The shaping process of the root canals will be accomplished by ProTaperNext (DentsplyMaillefer, Baillagues, Switzerland) up to the X3 instrument as standard in each patient. The study will be randomly divided into 3 groups (n= ) according to the irrigation solution used during shaping (G1: 1% NaOCl; G2: 2.5% NaOCl; G3: 5.25% NaOCl). 2 ml of irrigation solution will be applied after each file.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy persons between the ages of 18 and 45 years
  • •Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis

排除标准

  • •Patients who are taken analgesic inflammatory drugs with in the last 12 hours
  • •Pregnancy or lactation
  • •Teeth with periodontal diseases
  • •Teeth with sensitive to percussion and palpation
  • •Teeth with root resorption
  • •Teeth with immature/open apex

研究组 & 干预措施

1% NaOCIL

Active Comparator

2 ml of 1% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length.

干预措施: Irrigant concentration (Other)

1% NaOCIL

Active Comparator

2 ml of 1% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length.

干预措施: NaOCI (Drug)

2.5% NaOCI

Active Comparator

2 ml of 2.5% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length.

干预措施: Irrigant concentration (Other)

2.5% NaOCI

Active Comparator

2 ml of 2.5% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length.

干预措施: NaOCI (Drug)

5.25% NaOCI

Active Comparator

2 ml of 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length.

干预措施: Irrigant concentration (Other)

5.25% NaOCI

Active Comparator

2 ml of 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length.

干预措施: NaOCI (Drug)

结局指标

主要结局

IL-8 Level

时间窗: 6 months

Concentration of IL-8 in GCF

次要结局

未报告次要终点

研究者

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

Esin Özlek

Asis.Prof.

Yuzuncu Yıl University

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