Periodontitis, AdultPhase 1NCT05646459
Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.
A Phase 1 study testing cannabidiol, floss and proxabrush in people with Periodontitis, Adult and Inflammation Gum, run by University of Nebraska.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult, Inflammation Gum
- What is being tested?
- cannabidiol, floss and proxabrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 May 2020to 14 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of chronic moderate-advanced periodontitis
- one 6-9 mm interproximal probing depth
- overall good systemic health
- history of regular PMT
Who cannot join
- systemic disease that significantly affect periodontal inflammation and bone turnover
- surgical periodontal therapy in the past year
- pregnant/breast-feeding females.
About this study
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.
Read the 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.
- Conditions
- Periodontitis, Adult, Inflammation Gum
- Being tested
- cannabidiol, floss, proxabrush
- Medical subject headings
- Chronic Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cannabidiolDrug
Also called CBD
This group will locally apply cannabidiol to a posterior, localized 6-9 mm bleeding periodontal pocket.
flossDevice
This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).
proxabrushDevice
Also called interproximal cleaner
This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).
| Study group | Role | What they receive |
|---|---|---|
| Control - Floss | Placebo comparator | Subjects will use only floss at study site Receives: Device: floss |
| Proxabrush - Control | Sham comparator | Subjects will use only proxabrush at study site. Receives: Device: proxabrush |
| Proxabrush - CBD | Experimental | Subject will use CBD + proxabrush on study site. Receives: Drug: cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level
Amount of epithelial attachment to tooth
Measured: baseline
Clinical Attachment Level
Amount of epithelial attachment to tooth
Measured: 6 months
Secondary outcomes (2)
Inflammatory Biomarkers
IL-1B, IL-10, IL-6
Measured: baseline
Inflammatory Biomarkers
IL-1b, IL-10, IL-6
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start14 May 2020
- Primary completion14 May 2020
- Study completion14 May 2020
Why it stopped: Study was unable to obtain IRB approval because CBD was not legal in Nebraska at that time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph B Bavitz, DMD, Study chair, UNMC College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646459
- Sponsor's protocol ID
- 0217-20-FB
- Status last verified
- Aug 2024
- First submitted
- 21 Apr 2020
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.
- ClinicalTrials.gov ID
- NCT05646459
- Acronym / sponsor ID
- 0217-20-FB
- Conditions
- Periodontitis, Adult, Inflammation Gum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was unable to obtain IRB approval because CBD was not legal in Nebraska at that time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control - Floss | Placebo comparator | Device: flossSubjects will use only floss at study site |
| Proxabrush - Control | Sham comparator | Device: proxabrushSubjects will use only proxabrush at study site. |
| Proxabrush - CBD | Experimental | Drug: cannabidiolSubject will use CBD + proxabrush on study site. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of chronic moderate-advanced periodontitis
- one 6-9 mm interproximal probing depth
- overall good systemic health
- history of regular PMT
Key exclusion criteria (3 listed)
- systemic disease that significantly affect periodontal inflammation and bone turnover
- surgical periodontal therapy in the past year
- pregnant/breast-feeding females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cannabidiolAlso: CBDThis group will locally apply cannabidiol to a posterior, localized 6-9 mm bleeding periodontal pocket. | Drug | Proxabrush - CBD |
| flossThis group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket). | Device | Control - Floss |
| proxabrushAlso: interproximal cleanerThis group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket). | Device | Proxabrush - Control |
Primary outcome
Clinical Attachment Level
Time frame: baseline
Amount of epithelial attachment to tooth
Clinical Attachment Level
Time frame: 6 months
Amount of epithelial attachment to tooth
2 secondary outcomes
Inflammatory Biomarkers
Time frame: baseline
Inflammatory Biomarkers
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Periodontitis, Adult
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Not yet recruitingObservational study
Evaluation of Changes in Oral Health-related Quality of Life During the Treatment of Periodontitis.
Periodontitis, Adult, Periodontitis
Recruiting
HbA1c Screening in Dental Care and Primary Care Referral in Patients With Advanced Periodontitis
Periodontitis, Adult, Prediabetes / Type 2 Diabetes
RecruitingObservational study
Changes in Microbial Status From Dentate, Edentulous and After Dental Implant Placement
Edentulous Mouth, Periodontal Diseases
Not yet recruiting
Profiling Gingival Crevicular Fluid β-Catenin Level With 8-OHdG and Total Antioxidants Capacity During Healing of Periodontal Pockets: A 3-month Clinical Trial
Periodontitis, Adult, Periodontal Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph B Bavitz, DMD study chair
UNMC College of Dentistry
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cannabidiol, floss and proxabrush in people with Periodontitis, Adult and Inflammation Gum, run by University of Nebraska.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Level (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024; AzTrials last refreshed its copy on 26 Oct 2026.