The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Probing Pocket Depth (PPD) at peri-implantitis sites
研究概览
简要总结
This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.
详细描述
This studies aims to investigate the effect of a probiotics in peri-implantitis patients as an adjunct to non-surgical therapy.
Study design: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind randomized, placebo controlled clinical trial. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients.
Selection of the study population: Adults, who consult at the departement of Periodontology at the University Hospital Leuven, with peri-implantitis and who fit the inclusion criteria will be asked to participate in this 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •>18 years of age
- •Patients with at least one implant* diagnosed with initial peri-implantitis.
- •Willing and able to give written informed consent
- •No signs of acute periodontitis
- •presence of keratinized tissue around treated implant(s)
排除标准
- •patients who smoke
- •patients with periodontitis
- •pregnant or lactating woman
- •patients with poorly controlled diabetes
- •patients taking bisphosphonate mediation
- •patient who had taken systemic antibiotics 3 months prior to treatment
- •peri-implantitis treatment 12 months prior intake
研究组 & 干预措施
Test
Probiotic tablet
干预措施: Probiotic - BioGaia (Other)
Control
Control tablet
干预措施: Placebo (Other)
结局指标
主要结局
Probing Pocket Depth (PPD) at peri-implantitis sites
时间窗: Baseline - 6 months
Pocket probing depth measured with Merrit-B probe
次要结局
- Bleeding on Probing (BoP) at peri-implantitis sites(Baseline - 6 months)
- Plaque at peri-implantitis sites(Baseline - 6 months)
- Microbial samples(Baseline - 6 months)
- Full mouth plaque score (FMPS)(Baseline - 6 months)