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临床试验/NCT07045636
NCT07045636已完成不适用

Microbial Modulation by PEMF on Paque Induced Mucositis in Dental Implants Placed in Human Jaws: Microbiome and Proteomic Analysis.

Jamil awad shibli2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年5月11日最近更新:

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

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

发起方
Jamil awad shibli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jamil awad shibli

Professor

University of Guarulhos

研究点 (2)

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