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

Periodontitis, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05646459
• Other study ID #: 0217-20-FB
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 2019
• Est. completion date: May 14, 2020

Study information

• Verified date: November 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 14, 2020
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Gingivitis
• Inflammation
• Inflammation Gum
• Periodontitis
• Periodontitis, Adult

Intervention

Drug:
• cannabidiol
This group will locally apply cannabidiol to a posterior, localized 6-9 mm bleeding periodontal pocket.

Device:
• floss
This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).
• proxabrush
This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Attachment Level	Amount of epithelial attachment to tooth	baseline
Primary	Clinical Attachment Level	Amount of epithelial attachment to tooth	6 months
Secondary	Inflammatory Biomarkers	IL-1B, IL-10, IL-6	baseline
Secondary	Inflammatory Biomarkers	IL-1b, IL-10, IL-6	6 months