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

NCT05646459 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 0217-20-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis, Adult; Inflammation Gum

Outcome Measures

Primary Outcomes (2)

• Clinical Attachment Level

  Amount of epithelial attachment to tooth

  baseline

• Clinical Attachment Level

  Amount of epithelial attachment to tooth

  6 months

Secondary Outcomes (2)

• Inflammatory Biomarkers

  baseline

• Inflammatory Biomarkers

  6 months

Study Arms (3)

Control - Floss

PLACEBO COMPARATOR

Subjects will use only floss at study site

Device: floss

Proxabrush - Control

SHAM COMPARATOR

Subjects will use only proxabrush at study site.

Device: proxabrush

Proxabrush - CBD

EXPERIMENTAL

Subject will use CBD + proxabrush on study site.

Drug: cannabidiol

Interventions

cannabidiol DRUG

This group will locally apply cannabidiol to a posterior, localized 6-9 mm bleeding periodontal pocket.

Also known as: CBD

Proxabrush - CBD

floss DEVICE

This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).

Control - Floss

proxabrush DEVICE

This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).

Also known as: interproximal cleaner

Proxabrush - Control

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of chronic moderate-advanced periodontitis
• one 6-9 mm interproximal probing depth
• overall good systemic health
• history of regular PMT

You may not qualify if:

• systemic disease that significantly affect periodontal inflammation and bone turnover
• surgical periodontal therapy in the past year
• pregnant/breast-feeding females.

Sponsors & Collaborators

• University of Nebraska: lead

MeSH Terms

Conditions

Chronic Periodontitis; Gingivitis

Interventions

Cannabidiol; Dental Devices, Home Care

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Gingival Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Dental Equipment; Dentistry; Oral Hygiene; Preventive Dentistry; Equipment and Supplies

Study Officials

• Joseph B Bavitz, DMD

  UNMC College of Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: December 12, 2022
• Study Start: May 14, 2020
• Primary Completion: May 14, 2020
• Study Completion: May 14, 2020
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share