跳至主要内容
临床试验/NCT02466646
NCT02466646已完成4 期

Evaluation of Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels and Periodontal Pathogens After Full-Mouth Disinfection Initial Periodontal Treatment in Generalized Aggressive Periodontitis Patients

Marmara University0 个研究点目标入组 42 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
42
主要终点
Probing Depth

研究概览

简要总结

The purpose of this study is to determine whether full-mouth disinfection is effective in the initial periodontal treatment of generalized aggressive periodontitis on clinical parameters, gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17) and periodontal pathogen levels compared with conventional initial periodontal treatment and full-mouth initial periodontal treatment.

The investigators' hypothesis is to test whether full-mouth disinfection in the initial periodontal treatment of generalized aggressive periodontitis enhance the clinical, biochemical and microbiological parameters in comparison to conventional initial periodontal treatment and full-mouth initial periodontal treatment.

详细描述

The present study aimed to compare the efficacy of conventional initial periodontal treatment (C-IPT), full-mouth disinfection IPT (FMD-IPT) and full-mouth IPT (FM-IPT) and the levels of gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17), Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Fusobacterium nucleatum, Prevotella intermedia, Parvimonas micra and Campylobacter rectus in patients with generalized aggressive periodontitis (GAgP) over 6-months period. Forty-two GAgP patients were randomly assigned into 3 groups. IPT was performed in a quadrant-wise manner at 1-week intervals in C-IPT, in 2 sessions within 24 hours in FM-IPT, and in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours in FMD-IPT. FMD-IPT group also used daily 0,2% chlorhexidine for 3 weeks. At baseline, 3 and 6 months clinical parameters consisting of plaque index, gingival index, probing depth, bleeding on probing and clinical attachment level were recorded, gingival crevicular fluid and microbiological samples were collected. Gingival crevicular fluid levels of IL-1β and IL-17 were analyzed using ELISA. The quantitative real-time polymerase chain reaction method was used for the quantitative detection of periodontal pathogens.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • No systemic diseases that could influence the outcome of the therapy
  • No smoking
  • No medications affecting periodontal tissues
  • No pregnancy or lactation
  • Presence of at least 15 teeth

排除标准

  • Received antibiotic treatment in the previous 3 months
  • Pregnancy and lactation
  • Received periodontal treatment in the previous 6 months
  • Presence of less than 15 teeth
  • Presence of systemic diseases

研究组 & 干预措施

Full-mouth Disinfection IPT

Active Comparator

Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Spray 0,2% and Klorhex® rinse 0,2% for 3 weeks).

干预措施: Klorhex® Gel, rinse and spray (Drug)

Conventional IPT

Experimental

Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.

干预措施: Conventional IPT (Procedure)

Full-mouth IPT

Experimental

Initial periodontal treatment was performed in 2 sessions within 24 hours.

干预措施: Full-mouth IPT (Procedure)

结局指标

主要结局

Probing Depth

时间窗: 6 months after initial periodontal treatment

次要结局

  • Bleeding on Probing(Baseline, 3 and 6 months after initial periodontal treatment)
  • Gingival Index(Baseline, 3 and 6 months after initial periodontal treatment)
  • Clinical Attachment Level(Baseline, 3 and 6 months after initial periodontal treatment)
  • Level of Porphyromonas Gingivalis(Baseline, 3 and 6 months after initial periodontal treatment)
  • Level of A. Actinomycetemcomitans(Baseline, 3 and 6 months after initial periodontal treatment)
  • Level of Prevotella Intermedia(Baseline, 3 and 6 months after initial periodontal treatment)
  • Level of Campylobacter Rectus(Baseline, 3 and 6 months after initial periodontal treatment)
  • Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)(Baseline, 3 and 6 months after initial periodontal treatment)
  • Level of Fusobacterium Nucleatum(Baseline, 3 and 6 months after initial periodontal treatment)
  • Level of Parvimonas Micra(Baseline, 3 and 6 months after initial periodontal treatment)
  • Plaque Index(Baseline, 3 and 6 months after initial periodontal treatment)

研究者

申办方类型
Other
责任方
Sponsor

相似试验