Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT01517334
Status:
COMPLETED
Last Update Posted:
2015-08-26
First Post:
2012-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008911', 'term': 'Minocycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-25', 'studyFirstSubmitDate': '2012-01-10', 'studyFirstSubmitQcDate': '2012-01-20', 'lastUpdatePostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory: Changes in proportions and numbers of red-complex bacteria (RCB)', 'timeFrame': 'Baseline to Day 30'}], 'primaryOutcomes': [{'measure': 'Change in mean Probing Depth of qualifying implant sites', 'timeFrame': 'Baseline to Day 180'}], 'secondaryOutcomes': [{'measure': 'Change in percentage of qualifying implants with Bleeding On Probing', 'timeFrame': 'Baseline to Day 180'}, {'measure': 'Change in mean Probing Depth of qualifying implant sites', 'timeFrame': 'Baseline to Day 90'}, {'measure': 'Change in percentage of qualifying implants with Bleeding on Probing', 'timeFrame': 'Baseline to Day 90'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peri-Implantitis']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the safety, effectiveness and anti-microbial effects of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement.\n\nThe hypothesis of the study is that Arestin in combination with mechanical debridement is more effective in the treatment of peri-implantitis when compared to mechanical debridement alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as measured at qualifying implant sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A minimum of one osseointegrated implant with a diagnosis of peri-implantitis\n* Absence of any significant oral soft tissue pathology\n* At least one peri-implant site with an average of 2 probing depth readings between 5mm and 7mm (inclusive) when using a light force and with bleeding on probing within 30 seconds of the probing\n* Confirmed evidence of pathologic bone loss\n* At least 1mm of keratinized gingiva present around the implant\n\nExclusion Criteria:\n\n* Pregnancy\n* Allergy to tetracycline-class drug(s)\n* Systemic medical condition(s) requiring antibiotic prophylaxis prior to invasive dental procedures\n* Presence of active systemic infectious disease such as hepatitis, HIV, history of tuberculosis\n* Diagnosis of clinically significant or unstable organic disease, or compromised healing potential\n* Signs of untreated advanced periodontal disease and/or poor oral hygiene\n* Subjects having a probing depth greater than 8mm at time of enrollment\n* Subjects presenting with mobility of any dental implant\n* Subjects having a qualifying implant under occlusal trauma or overloaded (as determined by the investigator)'}, 'identificationModule': {'nctId': 'NCT01517334', 'briefTitle': 'Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)', 'organization': {'class': 'INDUSTRY', 'fullName': 'OraPharma'}, 'officialTitle': 'Multi-Center Phase 3 Trial of Minocycline HCl 1 mg Microspheres for the Use in Subjects With Peri-Implantitis: Clinical and Microbiological Evaluations', 'orgStudyIdInfo': {'id': 'OP-P-5266-M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Treatment (minocycline HCl microspheres, 1mg) administered at Baseline (following randomization) and Day 90 to qualifying implant sites, plus full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180.', 'interventionNames': ['Drug: Minocycline HCl Microspheres']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment'}], 'interventions': [{'name': 'Minocycline HCl Microspheres', 'type': 'DRUG', 'otherNames': ['Arestin (brand name)'], 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland, School of Dentistry', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts University School of Dental Medicine', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan - Michigan Center for Oral Health Research', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri - Kansas City School of Dentistry Clinical Research Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill School of Dentistry', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania School of Dental Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29403', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina College of Dental Medicine', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'UTHSC - College of Dentistry', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '98056', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University School of Dentistry', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53233', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marquette University School of Dentstry', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Steven Offenbacher, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina - Chapel Hill Dental School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OraPharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}