Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT00371332
Status:
COMPLETED
Last Update Posted:
2006-09-25
First Post:
2006-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'statusVerifiedDate': '2006-09', 'lastUpdateSubmitDate': '2006-09-22', 'studyFirstSubmitDate': '2006-09-01', 'studyFirstSubmitQcDate': '2006-09-01', 'lastUpdatePostDateStruct': {'date': '2006-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days.'}], 'secondaryOutcomes': [{'measure': 'Changes in the numbers of each of the primary pathogens, changes in pocket depth, attachment level, and proportion of sites bleeding on probing'}]}, 'conditionsModule': {'keywords': ['chronic periodontitis, mouth', 'Moderate to advanced chronic periodontitis'], 'conditions': ['Periodontitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://download.veritasmedicine.com/PDF/OPI-145_CSR.pdf', 'label': 'Effect of Adjunctive Treatment with Arestin on the Subgingival Microflora in Patients with Moderate to Advanced Periodontitis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generalized moderate to advanced chronic periodontitis, five sites with probing depths of \\>5 mm in 5 non-adjacent interproximal spaces, excluding the distal of terminal teeth, at least 16 teeth excluding 3rd molars and implants\n\nExclusion Criteria:\n\n* Allergy to tetracycline\n* Subjects with aggressive periodontitis\n* Acute necrotizing ulcerative gingivitis, or gross decay\n* Systemic conditions which could influence the course of periodontal disease (i.e, diabetes, autoimmune disease, etc)\n* Individuals requiring prophylactic antibiotics\n* Any periodontal therapy within the previous 3 months (excluding maintenance therapy)\n* Systemic or local antibiotic therapy within three months'}, 'identificationModule': {'nctId': 'NCT00371332', 'briefTitle': 'Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'OraPharma'}, 'orgStudyIdInfo': {'id': "OPI-145'"}}, 'armsInterventionsModule': {'interventions': [{'name': 'Minocycline HCL Microspheres', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OraPharma', 'class': 'INDUSTRY'}}}}