The Use of a Probiotic Lozenge in the Treatment of Residual Pockets After Classical Non-surgical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pocket Probing Depth (PPD) at teeth with residual pockets
研究概览
简要总结
The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm 3 months following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.
详细描述
The aim of this study is to determine the efficacy of the usage of a probiobitc lozenge in patients with residual bleeding pockets of ≥ 5mm following scaling and rootplaning. Simultaneously the additional benefit of subgingival application of probiotics via oil drops will be investigated.
Recruitment: This study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial with within each patient a split mouth design. 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 department of Periodontology at the University Hospital Leuven, 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
- •40 patients
- •≥ 18 years of age
- •scaling and rootplaning received at least 3 months ago
- •Patients diagnosed with residual pockets (at least 2), with the definition of residual pockets:> 5mm or 5 and BOP+
- •Willing and able to give written informed consent
排除标准
- •patients with aggressive periodontitis
- •patients who smoke
- •pregnant or lactating woman
- •patients with poorly controlled diabetes
- •patients taking bisphosphonate mediation
- •patient who had taken systemic antibiotics 3 months prior to treatment
研究组 & 干预措施
Test
Probiotic tablet
干预措施: Probiotic tablet- Biogaia (Other)
Control
Control tablet
干预措施: Placebo tablet (Other)
结局指标
主要结局
Pocket Probing Depth (PPD) at teeth with residual pockets
时间窗: 3-6 months
Recessions (REC) at teeth with residual pockets
时间窗: 3-6 months
Clinical Attachment Loss (CAL) at teeth with residual pockets
时间窗: 3-6 months
次要结局
- Overall PPD, REC, CAL(3-6 months)
- Plaque at teeth with residual pockets(3-6 months)
- Bleeding on Probing (BoP) at teeth with residual pockets(3-6 months)
- Microbial samples: deepest pocket, saliva, tongue(3-6 months)
- Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS)(3-6 months)