Effects of Prebiotic Oral Healthcare Products as an Adjunct to Non-surgical Periodontal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 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 impact of a prebiotic toothpaste and mouthrinse in periodontitis patients as an adjunct to scaling and rootplaning.
详细描述
The aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in periodontitis patients as an adjunct to scaling and rootplaning. 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. 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
- 盲法
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40 patients
- •≥ 36 years of age
- •Page 4 of 4 [DRAFT] -
- •No previous scaling and rootplaning
- •Clinical diagnosis: severe generalized periodontitis characterized by the presence of > 14 affected teeth when > 14 teeth are present (if number of teeth present is < 14, 8-14 teeth need to be affected) with an attachment loss of > 6mm prior to initial non-surgical periodontal therapy.
- •A minimum of 3 natural teeth in every quadrant
- •Willing and able to give written informed consent
排除标准
- •Patients with aggressive periodontitis or necrotizing periodontitis
- •Patients who smoke
- •Pregnant or lactating woman
- •A history of diabetes, rheumatic fever, liver or kidney disease, neurological deficiencies, or use of medication which may affect periodontal tissue, (phenytoin, cyclosporin, nifedipine, chronic use of non-steroidal antiinflammatory drugs)
- •Patients with poorly controlled diabetes
- •Patients taking bisphosphonate mediation
- •Patient who have taken systemic antibiotics 3 months prior to treatment
结局指标
主要结局
Pocket Probing Depth (PPD) at teeth with residual pockets
时间窗: Baseline - 6 months
Pocket probing depth measured with Merrit B prob
次要结局
未报告次要终点