Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Clinical Attachment Level
研究概览
简要总结
This study will determine if cannabidiol (CBD) has any effect on local inflammation in periodontal maintenance patients. Many successful therapies exist for the active, untreated periodontal patient. Unfortunately, periodontology has not yet discovered a therapy that will predictably treat local inflammation in patients who are at risk for further pocketing, bleeding on probing, bone loss and ultimately, tooth loss. Although CBD has been patented in various forms since the 1940s, its acceptance and availability to patients has only recently expanded. Marketing of CBD to periodontal patients as a means to control inflammation is commonplace online and in CBD-specific shops. In determining if CBD is a successful supplement to conventional periodontal inflammation control therapies, millions of patients could benefit from this treatment.
详细描述
The purpose of this study is to determine if CBD has any effect on local inflammation in periodontal maintenance patients. This research is significant and innovative as it will act as a pivotal study to determine if CBD is worthy of further study in the area of periodontal disease and it will be a human clinical trial focusing on a specific aspect of periodontal disease, the maintenance patient. Many successful therapies exist for the active, untreated periodontal patient. Unfortunately, periodontology has not yet discovered a therapy that will predictably treat local inflammation in these patients which are at risk for further pocketing, bleeding on probing, bone loss and ultimately, tooth loss. Although CBD has been patented in various forms since the 1940s, its acceptance and availability to patients has only recently expanded exponentially. Marketing of CBD to periodontal patients as a means to control inflammation is already commonplace online and in CBD-specific shops; it is the duty of periodontology to determine the efficacy and success of this known anti-inflammatory compound as it relates to clinical periodontal parameters. To determine if CBD is a successful adjunct to conventional periodontal inflammation control therapies would be a boon to the advancement of oral health and to millions of patients that could benefit from this treatment.
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)
入排标准
- 年龄范围
- 40 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of chronic moderate-advanced periodontitis
- •one 6-9 mm interproximal probing depth
- •overall good systemic health
- •history of regular PMT
排除标准
- •systemic disease that significantly affect periodontal inflammation and bone turnover
- •surgical periodontal therapy in the past year
- •pregnant/breast-feeding females.
研究组 & 干预措施
Control - Floss
Subjects will use only floss at study site
干预措施: floss (Device)
Proxabrush - Control
Subjects will use only proxabrush at study site.
干预措施: proxabrush (Device)
Proxabrush - CBD
Subject will use CBD + proxabrush on study site.
干预措施: cannabidiol (Drug)
结局指标
主要结局
Clinical Attachment Level
时间窗: 6 months
Amount of epithelial attachment to tooth
次要结局
- Inflammatory Biomarkers(6 months)
