Periodontitis, Adult, Inflammation Gum
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGcannabidiol
This group will locally apply cannabidiol to a posterior, localized 6-9 mm bleeding periodontal pocket.
DEVICEfloss
This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).
DEVICEproxabrush
This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* diagnosis of chronic moderate-advanced periodontitis * one 6-9 mm interproximal probing depth * overall good systemic health * history of regular PMT
Exclusion criteria
* systemic disease that significantly affect periodontal inflammation and bone turnover * surgical periodontal therapy in the past year * pregnant/breast-feeding females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level | baseline | Amount of epithelial attachment to tooth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Biomarkers | baseline | IL-1B, IL-10, IL-6 |
Outcome results
None listed