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

Phase 1

Withdrawn

• Conditions: Periodontitis, Adult; Inflammation Gum
• Interventions: Drug: cannabidiol; Device: floss; Device: proxabrush

• Registration Number: NCT05646459
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study Start: 2019-06
• Study First Submitted: 2020-04-21
• Primary Completion: 2020-05-14
• Study Completion: 2020-05-14
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proxabrush - CBD	cannabidiol	Subject will use CBD + proxabrush on study site.
Control - Floss	floss	Subjects will use only floss at study site
Proxabrush - Control	proxabrush	Subjects will use only proxabrush at study site.

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level	6 months	Amount of epithelial attachment to tooth

Secondary Outcome Measures

Name	Time	Method
Inflammatory Biomarkers	6 months	IL-1b, IL-10, IL-6