Microbial Modulation by PEMF on Paque Induced Mucositis in Dental Implants Placed in Human Jaws: Microbiome and Proteomic Analysis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Number of clusters of microorganism
研究概览
简要总结
To evaluate the impact of Pulsed Electromagnetic Field (PEMF) on mucositis induced in humans around dental implants and correlate these possible effects with the proteomic profile of implants with and without PEMF and teeth. The hypothesis is that PEMF may modulate bacterial biofilm formation around dental implants and enhance the host response following plaque-induced peri-implant mucositis.
详细描述
As in natural teeth, bacterial colonization of the implant surface can trigger a reversible inflammatory process in the peri-implant soft tissue-defined mucositis. However, differences in the organization of peri-implant tissues may combat the progression of lesions associated with bacterial biofilm, resulting in a broader inflammatory infiltrate compared to periodontal tissues. Some previous studies have used electromagnetic pulses (PEMF-pulse electromagnetic fields) to modulate bacterial biofilm. Thus, the objective of this study will be to evaluate the host response pattern (proteomics, microbiome, and clinical) during the induction and progression of experimental gingivitis and mucositis in humans with the action of the electromagnetic pulse. Forty systemically healthy individuals will be included, who must present the need for two implant-supported restorations adjacent to the teeth. Individuals will receive oral hygiene instruction and professional prophylaxis fortnightly, 30 days before implant installation. The implants will be installed in time -60 days. After 60 days, at baseline, the healing abutment will be installed on the two implants, one conventional and the other with an electromagnetic pulse. At the same time, everyone will receive acetate plates to protect the selected areas (tooth and implants) during brushing, to be used for 21 days. Clinical periodontal parameters, microbiological (supragingival and subgingival biofilm), and immunological (crevicular fluid) collections will be obtained at 0, 3, 7, 14, 21, 42, and 60 days. The results will be evaluated for normality using the D'Agostino test. Then, parametric or non-parametric tests will be applied to compare the means/medians obtained between the gingivitis and mucositis groups in the different periods of the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization and placebo MED (medical device not activated or activated for the PEMF)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy individuals over 18 years of age
- •have at least 2 contiguous edentulous spaces
- •more than 15 teeth
- •have not undergone periodontal treatment for at least 6 months before the start of the study
排除标准
- •Individuals with extensive dental restorations;
- •with periodontal disease stages II to IV
- •with peri-implantitis and/or mucositis (Shibli et al. 2015);
- •individuals requiring previous grafting for implant insertion;
- •diabetics;
- •smokers or former smokers;
- •pregnant women; lactating women;
- •use of antibiotics or oral antiseptics in the last 6 months .
结局指标
主要结局
Number of clusters of microorganism
时间窗: time points 0, 3, 6, 7, 14, 21, 28, 42, and 60 days
amount of genera and microbial species detected and/or altered (reduction and increase)
次要结局
未报告次要终点
研究者
Jamil awad shibli
Professor
University of Guarulhos
