Clinical and Microbiological Evaluation of the Effect of Probiotic Lactobacillus Reuteri Prodentis in the Treatment of Mucositis and Periimplantitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Probing pocket depth
研究概览
简要总结
Evaluate clinically and microbiologically the effect of the oral probiotic Lactobacillus reuteri Prodentis (PerioBalance®, Sunstar, Switzerland) on implants with mucositis or periimplantitis, as a coadjuvant treatment of mechanical therapy.
详细描述
A total of 44 patients, 22 with mucositis and 22 with periimplantitis, were randomly assigned to either the control or the test group, so that 11 patients received placebo and 11 probiotic treatment. After the baseline clinical, radiological and microbiological examination, and once the study group was randomly assigned (probiotic or placebo), supragingival prophylaxis was performed in the mucositis group and subgingival mechanical therapy in the periimplantitis group. Then they get a container with 30 probiotic or placebo tablets and instructions on how and when to take them. At 30 and 90 days after beginning the treatment, a clinical, radiological and microbiological examination was performed.
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
The patients, the clinical examiner, the laboratory technician and the statistician did not know the content of the containers (probiotic or placebo).
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult patients with general good health,
- •non-smokers,
- •history of mild or moderate chronic periodontitis
- •at least one dental implant with probing pocket depth ≥4mm together with bleeding on probing and/or suppuration, and a fixed prosthetic restoration in function for at least 12 months,
- •compliance with the periodontal maintenance program,
- •accessibility during all the study period and receptiveness and ability to fulfill with the protocol.
排除标准
- •pregnant or lactating women,
- •patients who required prophylaxis of bacterial endocarditis or had taken local or systemic antibiotic, anti-inflammatory, antiseptic or probiotic therapy in the previous 3 months,
- •subjects who had received surgical periodontal treatment in the last 6 months,
- •uncontrolled periodontal disease,
- •previous or current history of alcoholism or smoking,
- •treatment with bisphosphonates, neurologic deficiencies, systemic diseases such as immunodeficiencies or uncontrolled diabetes, rheumatoid, hepatic, renal, cardiovascular or infectious pathologies, radiotherapy, chemotherapy, use of any medication which can affect at periodontal level,
- •lack of patient cooperation (failure to follow the treatment instructions and/or failure to attend visits),
- •implants with mobility and/or radiographic bone loss ≥ 5mm and/or ≥ 50% of implant length.
研究组 & 干预措施
Control group: placebo oral tablet
Placebo tablets. Intervention: 30 placebo tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.
干预措施: Placebo Oral Tablet (Device)
Test group: probiotic oral tablet
Probiotic tablets (Periobalance®, Sunstar, Switzerland). Intervention: 30 probiotic tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.
干预措施: Probiotic (Drug)
结局指标
主要结局
Probing pocket depth
时间窗: Differences between baseline and 30 and 90 days will be calculated.
The probing pocket depth was recorded, in millimeters and at six points per tooth and implant, as the distance from the gingival margin to the bottom of the periodontal pocket and peri-implant mucosa. Measurements will be performed by a masked and calibrated investigator.
次要结局
- Plaque index(Differences between baseline and 30 and 90 days will be calculated.)
- Bleeding on probing(Differences between baseline and 30 and 90 days will be calculated.)
- Microbiological tests(Differences between baseline and 30 and 90 days will be calculated.)
研究者
MARTA GALOFRÉ MERCADÉ
DDS, MS, Associated Professor
Universitat Internacional de Catalunya