Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.
Primary Purpose
Periodontitis, Adult, Inflammation Gum
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cannabidiol
floss
proxabrush
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis, Adult
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Sham Comparator
Experimental
Arm Label
Control - Floss
Proxabrush - Control
Proxabrush - CBD
Arm Description
Subjects will use only floss at study site
Subjects will use only proxabrush at study site.
Subject will use CBD + proxabrush on study site.
Outcomes
Primary Outcome Measures
Clinical Attachment Level
Amount of epithelial attachment to tooth
Clinical Attachment Level
Amount of epithelial attachment to tooth
Secondary Outcome Measures
Inflammatory Biomarkers
IL-1B, IL-10, IL-6
Inflammatory Biomarkers
IL-1b, IL-10, IL-6
Full Information
NCT ID
NCT05646459
First Posted
April 21, 2020
Last Updated
October 18, 2023
Sponsor
University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT05646459
Brief Title
Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.
Official Title
Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study was unable to obtain IRB approval because CBD was not legal in Nebraska at that time.
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
May 14, 2020 (Actual)
Study Completion Date
May 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Adult, Inflammation Gum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control - Floss
Arm Type
Placebo Comparator
Arm Description
Subjects will use only floss at study site
Arm Title
Proxabrush - Control
Arm Type
Sham Comparator
Arm Description
Subjects will use only proxabrush at study site.
Arm Title
Proxabrush - CBD
Arm Type
Experimental
Arm Description
Subject will use CBD + proxabrush on study site.
Intervention Type
Other
Intervention Name(s)
cannabidiol
Other Intervention Name(s)
CBD
Intervention Description
This group will locally apply cannabidiol to a posterior, localized 6-9 mm bleeding periodontal pocket.
Intervention Type
Device
Intervention Name(s)
floss
Intervention Description
This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).
Intervention Type
Device
Intervention Name(s)
proxabrush
Other Intervention Name(s)
interproximal cleaner
Intervention Description
This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).
Primary Outcome Measure Information:
Title
Clinical Attachment Level
Description
Amount of epithelial attachment to tooth
Time Frame
baseline
Title
Clinical Attachment Level
Description
Amount of epithelial attachment to tooth
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Inflammatory Biomarkers
Description
IL-1B, IL-10, IL-6
Time Frame
baseline
Title
Inflammatory Biomarkers
Description
IL-1b, IL-10, IL-6
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph B Bavitz, DMD
Organizational Affiliation
UNMC College of Dentistry
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.
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