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

NCT ID: NCT05646459

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-14
• Study Completion Date: 2020-05-14

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.

Conditions

Periodontitis, Adult; Inflammation Gum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control - Floss

Subjects will use only floss at study site

Group Type: PLACEBO_COMPARATOR

floss

Intervention Type: DEVICE

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

Proxabrush - Control

Subjects will use only proxabrush at study site.

Group Type: SHAM_COMPARATOR

proxabrush

Intervention Type: DEVICE

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

Proxabrush - CBD

Subject will use CBD + proxabrush on study site.

Group Type: EXPERIMENTAL

cannabidiol

Intervention Type: DRUG

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

Interventions

cannabidiol

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

Intervention Type: DRUG

floss

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

Intervention Type: DEVICE

proxabrush

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

Intervention Type: DEVICE

Other Intervention Names

CBD; interproximal cleaner

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph B Bavitz, DMD

Role: STUDY_CHAIR

UNMC College of Dentistry

Other Identifiers

0217-20-FB

Identifier Type: -

Identifier Source: org_study_id