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临床试验/NCT02684682
NCT02684682Unknown不适用

Effect of Self-performed Mechanical Control of Plaque Frequency in Patients With Historic of Periodontitis and in Maintenance

Universidade Federal de Santa Maria2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
39
试验地点
2
主要终点
Changes from baseline gingival index at 30, 60 and 90 days.

研究概览

简要总结

The purpose of this blind randomized clinical trial is to evaluate different frequencies in self-mechanical control of plaque in individuals with historic of periodontitis and in periodic and preventive maintenance in order to assess which frequencies are compatible with maintaining gingival health.

详细描述

Thirty nine subjects with at most 5% of the sites for GI= 2 (gingival health) will be randomized into three groups with different frequencies in self-mechanical control of plaque: Group 12 hours, 24 hours and 48 hours. The exams of plaque index, gingival index, probing depth, bleeding on probing, clinical attachment level and gingival crevicular fluid will be performed at baseline, 15, 30, 60 and 90 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Investigator)

入排标准

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

入选标准

  • Individuals with historic of periodontitis (loss of interproximal insertion ≥3mm in two or more non-adjacent teeth) treated in the Clinic of Postgraduate Periodontics at the Federal University of Santa Maria and included in the periodontal maintenance program;
  • Minimum age of 35;
  • Individuals with at least 12 teeth in the mouth;
  • Maximum of 15% of sites with gingivitis;
  • Maximum of 25% of sites with bleeding on probing.

排除标准

  • Pregnant women;
  • Individuals with dryness of the mouth (xerostomia);
  • Diabetics;
  • Psychomotor disturbances;
  • Orthodontic equipment;
  • Antimicrobial prophylaxis;
  • Individuals using any medication associated with gingival overgrowth;
  • Individuals that used antibiotic/anti -inflammatory in recent 3 months.

结局指标

主要结局

Changes from baseline gingival index at 30, 60 and 90 days.

时间窗: 30,60 and 90 days.

Assess how different frequencies of self-performed mechanical control of plaque interfere in gingival status.

次要结局

  • Changes from baseline plaque level at 30,60 and 90 days.(30,60 and 90 days.)
  • Changes from volume of gingival fluid at 30,60 and 90 days.(30,60 and 90 days.)

研究者

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

Juliana Maier

Master in dental science with an emphasis on periodontics

Universidade Federal de Santa Maria

研究点 (2)

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