NCT01941797已完成不适用
Experimental Peri-implant Mucositis in Humans
UConn Health2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Gingival Crevicular fluid volume collected at baseline and weekly up to 9 weeks
研究概览
简要总结
This is a pilot study. The investigators hypothesize that the peri-implant soft tissue response to de novo plaque accumulation is similar to that of normal gingival tissue in the same subjects.
The investigators propose to conduct a controlled clinical trial to evaluate peri-implant soft tissue response to de novo plaque accumulation in comparison to the response of gingival tissue in the same subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female ³21 years of age.
- •Oral site specific inclusion criteria:
- •Presence of 2 implants in the maxillary or mandibular arch supporting fixed restorations in function for at least 1 year (Test)
- •Presence of 2 teeth in the corresponding position of the implant (Control); -3) Absence of active infections at both test and control sites
- •Absence of radiographic bone loss at both test and control sites
- •Pocket depth ≤4mm at both test and control sites
- •must give written informed consent.
排除标准
- •Treatment with antibiotics for any dental or medical condition within 1 month before screening
- •Systemic diseases that require chronic use of anti-inflammatory medications, antibiotics or anticoagulants
- •Ongoing medications for systemic conditions initiated <3 months before the start of the study or the requirement to take prophylactic antibiotics for invasive dental procedures
- •Significant organ disease including impaired kidney function, heart murmur, rheumatic fever, bleeding disorder
- •Active infectious diseases such as hepatitis, tuberculosis and HIV
- •Clinically detectable caries and periodontal disease
- •Tobacco use of any kind
- •Use of medications affecting periodontal status (diphenylhydantoin, cyclosporine etc.)
- •No pregnancy or lactation or expectation to become pregnant within next 3 months.
- •Participants will be excluded from the study or analysis if any of the following occur during the study: 1) Changes in the patient medical status or medications that met the exclusion criteria; 2) Use of antimicrobial rinses; 3) Use of irrigating devices; 4) Subject noncompliance with stent wearing during the experimental mucositis/gingivitis phase and/or Vitamin C use; 5) Use of anti-inflammatory drugs or antibiotics; 6) allergic history to common toothpaste or mouth rinse ingredients.
- •Acute use of acetaminophen will be permitted.
结局指标
主要结局
Gingival Crevicular fluid volume collected at baseline and weekly up to 9 weeks
时间窗: 9 weeks
The gingival crevicular fluid ( GCF) volume is assessed using Periotron unit. The GCF volume is strongly correlated with peri-implant mucosa and gingival inflammation.
次要结局
未报告次要终点
研究者
研究点 (2)
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