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临床试验/NCT02316652
NCT02316652终止不适用

Using Chemical Pocket Disinfection as an Adjunct to Non-surgical Maintenance Therapy of Inflamed Periodontal Pockets

University of Nebraska2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2014年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
33
试验地点
2
主要终点
Probing depths

研究概览

简要总结

This study will determine whether the supplemental use of chemical pocket disinfection with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical pocket disinfection with scaling and root planing will have an effect on biomarkers of inflammation.

详细描述

The purpose of this study is to determine whether the adjunctive use of chemical pocket disinfection with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal probing depth (PD), reducing bleeding on probing (BOP), and gaining clinical attachment level (CAL). It also will assess whether chemical pocket disinfection with scaling and root planing will have an effect on biomarkers of inflammation, as indicated by presence of pro- and anti-inflammatory cytokines, compared to scaling and root planing alone. The chemical pocket disinfection therapy consists of delivering a sodium hypochlorite solution followed by a neutralizing citric acid solution to the test site. Pro-inflammatory interleukin-1 beta and anti-inflammatory interleukin-1 receptor antagonist will be measured from the gingival crevicular fluid sampled from sites of interest.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Periodontal maintenance patients, have at least one pocket greater than or equal to 5 mm with bleeding on probing

排除标准

  • Uncontrolled diabetics
  • Regular users of nonsteroidal antiinflammatory drugs
  • Individuals on anti-coagulants
  • Individuals that have used antibiotics in the previous 3 months or require prophylactic antibiotic coverage
  • Pregnant individuals

结局指标

主要结局

Probing depths

时间窗: 3 months

Periodontal probing depth (PD)

次要结局

  • Inflammatory markers(3 months)
  • Bleeding on probing(3 months)
  • Clinical attachment level(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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