Intervention With Inulin to Further Support Effectiveness of Sanative Therapy: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Probing depth
研究概览
简要总结
The aim of this study is to investigate the effectiveness of daily supplementation with inulin before, during and after sanative therapy (ST), on clinical outcomes of periodontal disease. The study design will allow the investigators to conclude if supplementation with inulin can favourably modulate oral microbiota prior to ST and can result in better periodontal health after ST.
详细描述
Periodontal disease is a chronic state of inflammation that can destroy the supporting tissues around the teeth, leading to a loss of connective tissue and the periodontal ligament, the resorption of alveolar bone and eventual tooth loss. Periodontal disease can also induce dysbiosis in the gut microbiome and contribute to low grade systemic inflammation. Prebiotic fibres such as inulin can selectively alter the intestinal microbiota to bring back a state of homeostasis by improving gut barrier functions and preventing inflammation. Through this mechanism, supplementation with inulin may be able to indirectly benefit periodontal health. The primary objective of this trial to determine if inulin supplementation, provided pre-sanative therapy (ST) through the healing phase (post-ST) is more effective than the placebo at improving clinical outcomes of periodontal health: decreasing both the number of sites with probing depths greater than or equal to 4 mm and increasing the absence of bleeding on probing (BOP). Secondary objectives include determining the effects of inulin supplementation pre- and post-ST on salivary markers of inflammation and periodontal-associated pathogens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
The intervention packages will be labelled with a unique code and there will be enough packages to account for the required number of participants. A member of the research team, not involved in providing the treatment, will be responsible for the randomization and labeling of the intervention packages, as well as creating a master list by matching the unique code to the treatment arm. The patient and care provider will be masked to the treatment arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both males and females age 19 years or older who are undergoing sanative therapy for moderate to severe chronic periodontitis are eligible
- •Provided informed, written consent
排除标准
- •Patients with severe periodontal disease that requires antibiotics with ST as part of their treatment
- •Hemoglobin A1c levels greater than 8% in the previous 3 months
- •Chronic GI conditions and/or infections (e.g. colon cancer, crohn's disease, inflammatory bowel disease, celiac disease and ulcerative colitis)
- •Current or previous use of antibiotics for management of non-periodontal conditions within the past 3 month
- •Current use of laxatives, prebiotics, probiotics and/or fibre supplements
- •Smokers and/or cannabis users
- •Pregnant or breast-feeding
结局指标
主要结局
Probing depth
时间窗: At post-sanative therapy (10 weeks after sanative therapy is completed)
This is a routine clinical measure of periodontal health (measured in mm)
Bleeding on probing (BOP)
时间窗: At post-sanative therapy (10 weeks after sanative therapy is completed)
This is a clinical measure of inflammation and represented as the percentage to bleeding sites that are measured at 6 sites per tooth
次要结局
- Periodontal-Associated Pathogens(At post-sanative therapy (10 weeks after sanative therapy is completed))
- Salivary markers of inflammation(At post-sanative therapy (10 weeks after sanative therapy is completed))
- Body Mass Index(At post-sanative therapy (10 weeks after sanative therapy is completed))
- Dietary assessment(At post-sanative therapy (10 weeks after sanative therapy is completed))
研究者
Wendy E. Ward, Ph.D.
Professor
Brock University