Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-02-24 @ 8:50 AM
Study NCT ID:
NCT05646459
Status:
WITHDRAWN
Last Update Posted:
2024-09-03
First Post:
2020-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002185', 'term': 'Cannabidiol'}, {'id': 'D003742', 'term': 'Dental Devices, Home Care'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003748', 'term': 'Dental Equipment'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009910', 'term': 'Oral Hygiene'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was unable to obtain IRB approval because CBD was not legal in Nebraska at that time.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Attachment Level', 'timeFrame': 'baseline', 'description': 'Amount of epithelial attachment to tooth'}, {'measure': 'Clinical Attachment Level', 'timeFrame': '6 months', 'description': 'Amount of epithelial attachment to tooth'}], 'secondaryOutcomes': [{'measure': 'Inflammatory Biomarkers', 'timeFrame': 'baseline', 'description': 'IL-1B, IL-10, IL-6'}, {'measure': 'Inflammatory Biomarkers', 'timeFrame': '6 months', 'description': 'IL-1b, IL-10, IL-6'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis, Adult', 'Inflammation Gum']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of chronic moderate-advanced periodontitis\n* one 6-9 mm interproximal probing depth\n* overall good systemic health\n* history of regular PMT\n\nExclusion Criteria:\n\n* systemic disease that significantly affect periodontal inflammation and bone turnover\n* surgical periodontal therapy in the past year\n* pregnant/breast-feeding females.'}, 'identificationModule': {'nctId': 'NCT05646459', 'briefTitle': 'Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Effect of Local Cannabidiol on Clinical and Inflammatory Outcomes in Periodontal Maintenance Patients.', 'orgStudyIdInfo': {'id': '0217-20-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control - Floss', 'description': 'Subjects will use only floss at study site', 'interventionNames': ['Device: floss']}, {'type': 'SHAM_COMPARATOR', 'label': 'Proxabrush - Control', 'description': 'Subjects will use only proxabrush at study site.', 'interventionNames': ['Device: proxabrush']}, {'type': 'EXPERIMENTAL', 'label': 'Proxabrush - CBD', 'description': 'Subject will use CBD + proxabrush on study site.', 'interventionNames': ['Drug: cannabidiol']}], 'interventions': [{'name': 'cannabidiol', 'type': 'DRUG', 'otherNames': ['CBD'], 'description': 'This group will locally apply cannabidiol to a posterior, localized 6-9 mm bleeding periodontal pocket.', 'armGroupLabels': ['Proxabrush - CBD']}, {'name': 'floss', 'type': 'DEVICE', 'description': 'This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).', 'armGroupLabels': ['Control - Floss']}, {'name': 'proxabrush', 'type': 'DEVICE', 'otherNames': ['interproximal cleaner'], 'description': 'This group will use floss alone at the test site (posterior, localized 6-9 mm bleeding periodontal pocket).', 'armGroupLabels': ['Proxabrush - Control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joseph B Bavitz, DMD', 'role': 'STUDY_CHAIR', 'affiliation': 'UNMC College of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}