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

Sponsor

University of Nebraska (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05646459

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis, Adult Inflammation Gum	Drug: cannabidiol Device: floss Device: proxabrush	Phase 1/Phase 2

Detailed Description

This study was not approved and therefore never commenced.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Clinical Attachment Level [baseline]
Amount of epithelial attachment to tooth
Clinical Attachment Level [6 months]
Amount of epithelial attachment to tooth

Secondary Outcome Measures

Inflammatory Biomarkers [baseline]
IL-1B, IL-10, IL-6
Inflammatory Biomarkers [6 months]
IL-1b, IL-10, IL-6

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Nebraska

Investigators

Study Chair: Joseph B Bavitz, DMD, UNMC College of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amy C. Killeen, DDS, MS, Associate Professor, University of Nebraska

ClinicalTrials.gov Identifier:

NCT05646459

Other Study ID Numbers:

Periodontal CBD Study

First Posted:

Dec 12, 2022

Last Update Posted:

Dec 12, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gingivitis

Periodontitis

Chronic Periodontitis

Inflammation

Cannabidiol

Study Results

No Results Posted as of Dec 12, 2022