Impact of a Triclosan-containing Toothpaste During the Progression of Experimental Peri-implant Mucositis: Clinical Parameters and Local Pattern of Osteo-immunoinflammatory Mediators in Peri-implant Fluid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 主要终点
- bleeding index
研究概览
简要总结
The aim of this study was to evaluate the influence of a triclosan-containing toothpaste in the profile of osteo-immunoinflammatory mediators in the peri-implant crevicular fluid (PICF) and in the clinical parameters during the progression of experimental peri-implant mucositis.
详细描述
Study design This investigation was designed as double-blind, randomized, crossover study to evaluate the influence of a triclosan-containing toothpaste in the profile of osteo-immunoinflammatory mediators in the PICF and in the clinical parameters during the progression of experimental peri-implant mucositis. This study was approved by the ethics committee of Paulista University (Protocol 97.117).
Population screening Patient recruitment started in June 2013 and was completed by the end of May 2014. The clinical procedures and evaluations were carried out between August 2013 and June 2014. Data entry and statistical analyses were performed in January 2015. All the patients in the study were recruited from the patients referred to Paulista University.
All eligible individuals were thoroughly informed of the nature, potential risks and benefits of their participation in the study, and they each signed an informed consent document.
Experimental groups During an experimental 3-week period of undisturbed plaque accumulation in the implants, patients were randomly assigned to two groups, according to chemical plaque control (three times per day): Triclosan (n=11): triclosan/copolymer/fluoride toothpaste or Placebo (n=11): fluoride toothpaste. Undisturbed plaque accumulation was achieved only in the nearby of dental implants by using an individual silicone tray involving the implant and adjacent teeth covering 2-3mm of peri-implant mucosa. The same silicone tray was filled by the respective toothpaste, according to the experimental group, during this period. Following 3 weeks, a professional prophylaxis was performed and a wash-out period of 30 days was established. Then, a second experimental 3-week period of undisturbed plaque accumulation in the implants was established and the experimental groups were exchanged. After that, a new professional prophylaxis was performed. All evaluations (clinical and immunoenzimatic assays) were performed at baseline, 3, 7, 14 and 21 days of each period of experimental mucositis induction.
The number of patients included in the present study was based on previous crossover investigations that found differences in the clinical parameters and crevicular fluid levels of osteo-immunoinflammatory markers in different clinical status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30 years old or more
- •present at least a 2-stage unitary screwed implant-supported single-unit crown in the molar or pre-molar region
- •implant connection should be external hexagonal and the implants should be in function at least 12 months with width of keratinized tissue > 2mm around implants
- •The peri-implant tissue should be healthy [probing depth (PD) <4mm with no bleeding on probing (BoP) and no evidence of radiographic bone loss beyond bone remodeling (AAP 2013).
- •Patients should be periodontally healthy and present full mouth plaque scores (FMPS, Ainamo & Bay 1975) and bleeding score (FMBS, Muhlemann & Son 1971) < 20%.
排除标准
- •pregnancy
- •lactation
- •systemic conditions r that could affect the progression of peri-implant diseases and bone metabolism (e.g., immunologic disorders), use of long-term administration of anti-inflammatory and immunosuppressive medications
- •antibiotic therapies in the previous 6 months
- •individuals that required bone grafts before or alongside the implant surgery
- •history of previous regenerative procedures in the area treated with implant therapy.
结局指标
主要结局
bleeding index
时间窗: 21 days
scored using dichotomous index of mucosal marginal bleeding around implants,
次要结局
- Position of the peri-implant margin(21 days)
- Osteo-immunoinflammatory mediators(21 days)
- plaque index(21 days)
- Peri-implant probing depth(21 days)
- Relative clinical attachment level(21 days)
研究者
Fernanda Vieira Ribeiro
Professor
Paulista University