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

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.

Study Overview

• Status: Withdrawn
• Conditions: Periodontitis, Adult; Inflammation Gum
• Intervention / Treatment: Device: floss; Device: proxabrush; Drug: cannabidiol

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.

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control - Floss; Subjects will use only floss at study site	Device: floss; This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).
Sham Comparator: Proxabrush - Control; Subjects will use only proxabrush at study site.	Device: proxabrush; This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).; Other Names: interproximal cleaner
Experimental: Proxabrush - CBD; Subject will use CBD + proxabrush on study site.	Drug: cannabidiol; This group will locally apply cannabidiol to a posterior, localized 6-9 mm bleeding periodontal pocket.; Other Names: CBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Attachment Level	Amount of epithelial attachment to tooth	baseline
Clinical Attachment Level	Amount of epithelial attachment to tooth	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Biomarkers	IL-1B, IL-10, IL-6	baseline
Inflammatory Biomarkers	IL-1b, IL-10, IL-6	6 months

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Study Chair: Joseph B Bavitz, DMD, UNMC College of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2020
• Primary Completion (Actual): May 14, 2020
• Study Completion (Actual): May 14, 2020

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Chronic Disease; Periodontitis; Inflammation; Gingivitis; Chronic Periodontitis; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 0217-20-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No