Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT00731432
Status:
SUSPENDED
Last Update Posted:
2011-07-20
First Post:
2008-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'whyStopped': 'Failure to recruit', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2008-08-07', 'studyFirstSubmitQcDate': '2008-08-08', 'lastUpdatePostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of the study will be the comparison between THPP and PP in reducing the gingival index (GI) at the site of patch placement', 'timeFrame': '5 days'}], 'secondaryOutcomes': [{'measure': 'frequency and severity of any adverse event', 'timeFrame': '5 days'}, {'measure': 'Beta-glucuronidase enzyme found in gingival crevicular fluid (GCF) of the tested sites. The GCF will be collected from the second most posterior tooth in all four quadrants.', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gingivitis, diabetes mellitus, herbal, oral inflammation'], 'conditions': ['Gingival Inflammation in Diabetic Patients']}, 'descriptionModule': {'briefSummary': 'Diabetes increases the incidence and severity of periodontal inflammation and disease, and periodontal disease causes an increase in the severity of diabetes by worsening glycemic control and increasing insulin resistance.The Transmucosal Herbal Periodontal Patch (THPP) is a transmucosal patch containing an herbal compound that has an anti-inflammatory effect on gingival tissue.The primary objective of this study is to determine the efficacy of the Transmucosal Herbal Periodontal Patch (THPP) compared with placebo patch (PP) in reducing gingival inflammation at the site of placement in diabetic patients. We also aim to determine if the THPP decreases gingival inflammation throughout the mouth and the safety of THPP compared with placebo patch when applied to the mucosa in the treatment of gingival inflammation in diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female patients between the ages of 18 and 85 years\n* Patients must have a minimum of 3 posterior teeth in all quadrants\n* A mean gingival index (GI) of \\>1.5 on the posterior teeth\n* Diagnosis of Diabetes type 1 or 2, adequately controlled by diet and/or medications, as determined by the patient's physician\n\nExclusion Criteria:\n\n* Allergy to any herbal medications\n* Pregnancy or lactation\n* Periodontal treatment in the last three months"}, 'identificationModule': {'nctId': 'NCT00731432', 'briefTitle': 'Herbal Periodontal Patch (THPP) for Gingival Inflammation in Diabetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Izun Pharma Ltd'}, 'officialTitle': 'The Effect Of A Transmucosal Herbal Periodontal Patch (THPP) on Gingival Inflammation in Diabetic Patients', 'orgStudyIdInfo': {'id': 'C-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Transmucosal Herbal Periodontal Patch (THPP)', 'interventionNames': ['Drug: Transmucosal Herbal Periodontal Patch (THPP)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Placebo Patch', 'interventionNames': ['Drug: Placebo Patch']}], 'interventions': [{'name': 'Transmucosal Herbal Periodontal Patch (THPP)', 'type': 'DRUG', 'otherNames': ['Day 1: 1 patch X 3/d', 'Day 2-3: 1 patch X1/d', 'Days 4-5: no patch'], 'description': 'Patch applied to oral gingiva', 'armGroupLabels': ['A']}, {'name': 'Placebo Patch', 'type': 'DRUG', 'otherNames': ['Day 1: 1 patch X 3/d', 'Day 2-3: 1 patch X1/d', 'Days 4-5: no patch'], 'description': 'Identical in shape and texture to treatment patch', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91035', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Herzog Hospital', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Oded Yaniv, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Izun Pharma Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izun Pharma Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr. Y. Caine', 'oldOrganization': 'Herzog Hospital, Jerusalem, Israel'}}}}