Clinical trial

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

Name

0217-20-FB

Description

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.

Trial arms

Trial start

2019-06-01

Estimated PCD

2020-05-14

Trial end

2020-05-14

Status

Withdrawn

Phase

Early phase I

Treatment

cannabidiol

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

Arms:

Proxabrush - CBD

Other names:

CBD

floss

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

Arms:

Control - Floss

proxabrush

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

Arms:

Proxabrush - Control

Other names:

interproximal cleaner

Primary endpoint

Clinical Attachment Level

baseline

Clinical Attachment Level

6 months

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2023-12-04

1 organization

1 drug

3 indications

Organization

University of Nebraska

Drug

Indication

Indication

Indication