{ "FullStudy":{ "Rank":217749, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517334", "OrgStudyIdInfo":{ "OrgStudyId":"OP-P-5266-M" }, "Organization":{ "OrgFullName":"OraPharma", "OrgClass":"INDUSTRY" }, "BriefTitle":"Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)", "OfficialTitle":"Multi-Center Phase 3 Trial of Minocycline HCl 1 mg Microspheres for the Use in Subjects With Peri-Implantitis: Clinical and Microbiological Evaluations" }, "StatusModule":{ "StatusVerifiedDate":"April 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 25, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 26, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"OraPharma", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "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." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Peri-Implantitis" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"208", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Treatment", "ArmGroupType":"Experimental", "ArmGroupDescription":"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.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Minocycline HCl Microspheres" ] } },{ "ArmGroupLabel":"Control", "ArmGroupType":"No Intervention", "ArmGroupDescription":"Full-mouth mechanical debridement (deep cleaning) at Baseline and Day 180; no treatment" } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Minocycline HCl Microspheres", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Treatment" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Arestin (brand name)" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in mean Probing Depth of qualifying implant sites", "PrimaryOutcomeTimeFrame":"Baseline to Day 180" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change in percentage of qualifying implants with Bleeding On Probing", "SecondaryOutcomeTimeFrame":"Baseline to Day 180" },{ "SecondaryOutcomeMeasure":"Change in mean Probing Depth of qualifying implant sites", "SecondaryOutcomeTimeFrame":"Baseline to Day 90" },{ "SecondaryOutcomeMeasure":"Change in percentage of qualifying implants with Bleeding on Probing", "SecondaryOutcomeTimeFrame":"Baseline to Day 90" } ] }, "OtherOutcomeList":{ "OtherOutcome":[ { "OtherOutcomeMeasure":"Exploratory: Changes in proportions and numbers of red-complex bacteria (RCB)", "OtherOutcomeTimeFrame":"Baseline to Day 30" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nA minimum of one osseointegrated implant with a diagnosis of peri-implantitis\nAbsence of any significant oral soft tissue pathology\nAt 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\nConfirmed evidence of pathologic bone loss\nAt least 1mm of keratinized gingiva present around the implant\n\nExclusion Criteria:\n\nPregnancy\nAllergy to tetracycline-class drug(s)\nSystemic medical condition(s) requiring antibiotic prophylaxis prior to invasive dental procedures\nPresence of active systemic infectious disease such as hepatitis, HIV, history of tuberculosis\nDiagnosis of clinically significant or unstable organic disease, or compromised healing potential\nSigns of untreated advanced periodontal disease and/or poor oral hygiene\nSubjects having a probing depth greater than 8mm at time of enrollment\nSubjects presenting with mobility of any dental implant\nSubjects having a qualifying implant under occlusal trauma or overloaded (as determined by the investigator)", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"21 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Steven Offenbacher, DDS", "OverallOfficialAffiliation":"University of North Carolina - Chapel Hill Dental School", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University of Maryland, School of Dentistry", "LocationCity":"Baltimore", "LocationState":"Maryland", "LocationZip":"21201", "LocationCountry":"United States" },{ "LocationFacility":"Tufts University School of Dental Medicine", "LocationCity":"Boston", "LocationState":"Massachusetts", "LocationZip":"02111", "LocationCountry":"United States" },{ "LocationFacility":"University of Michigan - Michigan Center for Oral Health Research", "LocationCity":"Ann Arbor", "LocationState":"Michigan", "LocationZip":"48106", "LocationCountry":"United States" },{ "LocationFacility":"University of Missouri - Kansas City School of Dentistry Clinical Research Center", "LocationCity":"Kansas City", "LocationState":"Missouri", "LocationZip":"64108", "LocationCountry":"United States" },{ "LocationFacility":"University of North Carolina at Chapel Hill School of Dentistry", "LocationCity":"Chapel Hill", "LocationState":"North Carolina", "LocationZip":"27599", "LocationCountry":"United States" },{ "LocationFacility":"University of Pennsylvania School of Dental Medicine", "LocationCity":"Philadelphia", "LocationState":"Pennsylvania", "LocationZip":"19104", "LocationCountry":"United States" },{ "LocationFacility":"Medical University of South Carolina College of Dental Medicine", "LocationCity":"Charleston", "LocationState":"South Carolina", "LocationZip":"29403", "LocationCountry":"United States" },{ "LocationFacility":"UTHSC - College of Dentistry", "LocationCity":"Memphis", "LocationState":"Tennessee", "LocationZip":"38163", "LocationCountry":"United States" },{ "LocationFacility":"Virginia Commonwealth University School of Dentistry", "LocationCity":"Richmond", "LocationState":"Virginia", "LocationZip":"98056", "LocationCountry":"United States" },{ "LocationFacility":"Marquette University School of Dentstry", "LocationCity":"Milwaukee", "LocationState":"Wisconsin", "LocationZip":"53233", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000008911", "InterventionMeshTerm":"Minocycline" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000900", "InterventionAncestorTerm":"Anti-Bacterial Agents" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M10462", "InterventionBrowseLeafName":"Minocycline", "InterventionBrowseLeafAsFound":"Minocycline", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2803", "InterventionBrowseLeafName":"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000057873", "ConditionMeshTerm":"Peri-Implantitis" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000010510", "ConditionAncestorTerm":"Periodontal Diseases" },{ "ConditionAncestorId":"D000009059", "ConditionAncestorTerm":"Mouth Diseases" },{ "ConditionAncestorId":"D000009057", "ConditionAncestorTerm":"Stomatognathic Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M27480", "ConditionBrowseLeafName":"Peri-Implantitis", "ConditionBrowseLeafAsFound":"Peri-implantitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M12002", "ConditionBrowseLeafName":"Periodontal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10602", "ConditionBrowseLeafName":"Mouth Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10600", "ConditionBrowseLeafName":"Stomatognathic Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC07", "ConditionBrowseBranchName":"Mouth and Tooth Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }