THE EFFECT OF ORALLY ADMINISTERED PROBIOTIC LACTOBACILLUS REUTERI-CONTAINING TABLETS IN PERI-IMPLANT MUCOSITIS: A RANDOMIZED CLINICAL TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Evidence in reduction of plaque index
研究概览
简要总结
The aim of this study was evaluate the effects of the oral probiotic Lactobacillus reuteri Prodentis upon the peri-implant health of edentulous patients with dental implants and peri-implant mucositis, establishing comparisons versus implants without peri-implant disease. The hypothesis of the study is that using these probiotics are going to improve the periimplant health.
详细描述
A double-blind, placebo-controlled, prospective cross-over study was made. All the patients were edentulous and were divided into two groups: A) with no peri-implant disease; B) with peri-implant mucositis affecting one or more implants. Patients with peri-implantitis were excluded. All patients in both groups initially received the oral probiotic Lactobacillus reuteri Prodentis, followed by placebo. Only the supervisor of the study knew this information; clinical examiner and patients were blind. Were studied: crevicular fluid volume, modified plaque index, probing depth, modified gingival index, and concentrations of interleukin 1β, interleukin 6 and interleukin 8, and Bacterial load.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Totally edentulous patients subjected to dental implant rehabilitation in one or both arches
- •Prosthetic restoration in function for at least 24 months
- •Healthy individuals without known disease
排除标准
- •Patients receiving any kind of local or systemic decontamination treatment of the oral cavity (e.g., antibiotics or rinses) in the last 3 months, or periodontal treatment in the last 6 months
- •Uncontrolled periodontal disease
- •Patients with immune deficiencies, diabetes, rheumatoid disease, head and neck radiotherapy, bisphosphonate treatment, chemotherapy or anticoagulation
- •Patients with dental implants presenting intraoral exposure of the rough portion of any implant
- •Incomplete protocols due to a lack of patient cooperation: a) failure to follow the treatment instructions; b) failure to report to the visit after one month of follow-up
- •Failure to provide informed consent to participation the study
- •Patients presenting at least one implant with peri-implantitis
结局指标
主要结局
Evidence in reduction of plaque index
时间窗: 28 days using one probiotic tablet/day
The Mombelli clasification was used to evaluate the reduction of bacterial plaque. 0: No bacterial plaque; 1: presence of bacterial plaque but not visually; 2: 1/3 part of the implant with bacterial plaque; 3: 2/3 parts or more of the implant with bacterial plaque
次要结局
- Evidence in reduction of bleeding around implants(28 days using probiotic tablet/day)
- Evidence in reduction of probing depth(28 days using one probiotic tablet/day)
- Evidence in reduction Interleukin 1β concentration(28 days using one probiotic tablet/day)
- Evidence in reduction Interleukin 6 concentration(28 days using one probiotic tablet/day)
- Evidence in reduction Interleukin 8 concentration(28 days using one probiotic tablet/day)
研究者
Antonio Juan Flichy Fernández
DDS, Colaborator University of Valencia
University of Valencia