跳至主要内容
临床试验/NCT05646459
NCT05646459撤回1 期

Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.

University of Nebraska0 个研究点开始时间: 2019年6月最近更新:
适应症
干预措施

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

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

Placebo Comparator

Subjects will use only floss at study site

干预措施: floss (Device)

Proxabrush - Control

Sham Comparator

Subjects will use only proxabrush at study site.

干预措施: proxabrush (Device)

Proxabrush - CBD

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

相似试验

Effect of Local Cannabidiol on Clinical and... | 临床试验