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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Withdrawn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
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis, Adult

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 21, 2020
    Last Updated
    October 18, 2023
    Sponsor
    University of Nebraska
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    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    Withdrawn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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