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临床试验/NCT04556708
NCT04556708已完成不适用

Ozonated Water Irrigation as an Adjunct to Mechanical Periodontal Therapy in Patients With Periodontitis: A Randomized Clinical Trial

Abant Izzet Baysal University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年4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
72
试验地点
2
主要终点
vascular endothelial growth factor level

研究概览

简要总结

The use of chlorhexidine or ozonized water in periodontal pockets accompanying NPT can provide a significant improvement in probing pocket depths compared to conventional treatment. However, the effect of subgingival ozonized water applications on VEGF and IGF levels, which are thought to play a role in the pathogenesis of periodontal disease and periodontal regeneration, should be examined.

详细描述

Background: This study aims to evaluate the effects of subgingival ozonated water irrigation as an adjunct to non-surgical periodontal treatment on clinical and biochemical parameters of patients with moderate and severe periodontitis.

Methods: A total of 72 stage II and Stage III periodontitis patients were included in the study. The systemically healthy patients which were between the ages of 19 and 58 were treated non-surgically. At the end of each visit concerning periodontal treatment, the pocket of each tooth was irrigated with a sterile plastic syringe (10 mL per quadrant) with a blunt tip containing ozonated water (OW; ozone groups), 0.12% chlorhexidine digluconate (CHX groups) or saline (C; control groups) for 30-60 s. Periodontal clinical parameters, gingival crevicular fluid (GCF) vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) levels were evaluated at baseline and 8 weeks after periodontal treatment. All statistical data were analyzed using SPSS software.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • good general health without a history of systemic disease (hyperthyroid, diabetes, etc.)
  • ≥ 20 teeth
  • having not received periodontal treatment within the past 6 months
  • no contraindication for periodontal therapy and ozone application
  • presenting moderate-to-severe periodontitis according to criteria outlined by 2017 World Workshop.

排除标准

  • use of anti-inflammatory and antibiotic drugs within the past 6 months
  • pregnancy, lactation or use of oral contraceptives

结局指标

主要结局

vascular endothelial growth factor level

时间窗: Baseline and after 8 weeks

Changes in the concentration of vascular endothelial growth factor in all groups within 8 weeks after periodontal treatment were measured.

次要结局

  • Gingival index(Baseline and after 8 weeks)
  • Probing pocket depth(Baseline and after 8 weeks)
  • Clinical attachment level(Baseline and after 8 weeks)
  • Bleeding on probing(Baseline and after 8 weeks)
  • insulin-like growth factor-1 level(Baseline and after 8 weeks)
  • Plaque index(Baseline and after 8 weeks)

研究者

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

Ozge Gokturk

Principal Investigator

Abant Izzet Baysal University

研究点 (2)

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