Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-28 @ 2:02 AM
Study NCT ID:
NCT05562635
Status:
UNKNOWN
Last Update Posted:
2023-07-21
First Post:
2022-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D002012', 'term': 'Bruxism'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D006184', 'term': 'Habits'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two groups parallel study: experimental and control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-20', 'studyFirstSubmitDate': '2022-08-31', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in masseter muscle electromyographic activity- sEMG examination', 'timeFrame': '30 days', 'description': 'Change in masseter muscle electromyographic activity-sEMG examination'}, {'measure': 'Orofacial pain changes', 'timeFrame': '30 days', 'description': 'Changes of felt pain recorded by means of VAS scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['temporomandibular disorder', 'orofacial pain', 'CBD', 'bruxism', 'masticatory muscles'], 'conditions': ['Temporomandibular Disorder', 'Myofascial Pain', 'Orofacial Pain', 'CBD', 'Bruxism']}, 'descriptionModule': {'briefSummary': 'The aim of the project is to assess the effectiveness of reducing the masseter muscles tension and hyperactivity in patients with a painful form of TMD by using polymers containing CBD compared to placebo polymers.', 'detailedDescription': 'Since the healing properties of CBD have been known for a long time, the assumption of the proposed research is to reduce the tension of the masseter muscles, reduce the bruxism index and occlusal strength, as well as reduce pain, from which patients with TMD suffer.\n\nCBD intraoral application therapy seems promising in that field. Patients attending The Department of TMD in Zabrze, Polska will be randomly divided into two groups: experimental and placebo. sEMG activity values will be compared during 14 and 30 days therapy with polymers. the efficacy of the cannabis cream used in the study. Positive results will confirm the efficacy of CBD relaxing properties used in the study, compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient agreement to participate into the research study\n* Age ≥18 and ≤ 60\n* Good general health,\n* Temporomandibular disorder-positive RDC/TMD examination for group Ia and Ib\n* Presence of all teeth (with the exception of the third molars)\n\nExclusion Criteria:\n\n* Cannabis cream/ placebo cream allergy\n* Hypersensitivity to substances to be used in the study\n* Wounds intra oral cavity\n* Addiction to cannabis\n* Patients being treated with analgesic drugs and/or drugs that affect muscle function'}, 'identificationModule': {'nctId': 'NCT05562635', 'briefTitle': 'CBD (Cannabidiol) Intraoral Application and TMD (Temporomandibular Disorders)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Silesia'}, 'officialTitle': 'Assesment of ODF ( Oral Dissolvable Film) With Long-term CBD Release in the Treatment of Temporomandibular Disorders', 'orgStudyIdInfo': {'id': 'CBD (Cannabidiol)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5 % polymers with CBD application', 'description': 'Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle', 'interventionNames': ['Combination Product: 5% polymer gel with CBD application']}, {'type': 'EXPERIMENTAL', 'label': '10 % polymers with CBD application', 'description': 'Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle', 'interventionNames': ['Combination Product: 10% polymer gel with CBD application']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Application of polymers without CBD on the masseter muscles, bilaterally', 'interventionNames': ['Combination Product: Placebo intervention']}], 'interventions': [{'name': '5% polymer gel with CBD application', 'type': 'COMBINATION_PRODUCT', 'description': 'Bilateral application of 5% polymer gel with CBD intraorally, on the masseter muscle', 'armGroupLabels': ['5 % polymers with CBD application']}, {'name': '10% polymer gel with CBD application', 'type': 'COMBINATION_PRODUCT', 'description': 'Bilateral application of 10% polymer gel with CBD intraorally, on the masseter muscle', 'armGroupLabels': ['10 % polymers with CBD application']}, {'name': 'Placebo intervention', 'type': 'COMBINATION_PRODUCT', 'description': 'Application of placebo without CBD', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41-800', 'city': 'Zabrze', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Karolina Walczyńska-Dragon, PhD', 'role': 'CONTACT', 'email': 'karolina.dragon@sum.edu.pl', 'phone': '0048609289137'}, {'name': 'Aleksandra Nitecka-Buchta, dr hab. n. med.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stefan Baron, Prof', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of TMD', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Silesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}