[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615857":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":43,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":33,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":33,"enrollmentInfo":75,"targetDuration":33,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":45,"whyStopped":33,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Case Western Reserve University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test Group","EXPERIMENTAL","Minocycline microspheres (Arestin®) \u002F (4 mg per cartridge) prefilled delivery syringe \u002F Arestin will be placed in the pocket only one time after scaling and root planing.",[13],"Drug: local antibiotic application of topical minocycline",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","ACTIVE_COMPARATOR","Scaling and Root Planing Alone",[19],"Procedure: Scaling and Root Planing",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","local antibiotic application of topical minocycline","Scaling and Root planing + local application of Arestin ( Minocycline microsphere)",[9],[27],"Arestin Minocicline microsphere",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"PROCEDURE","Scaling and Root Planing","Only scaling and root planing",[15],null,[35],{"name":36,"affiliation":5,"role":37},"Gian Pietro Schincaglia, DDS, PhD","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":33,"email":42},"CONTACT","216-368-4412","gxs486@case.edu",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Cleveland","Ohio","44106","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-81.69541,41.4995,{"lat":55,"lon":54},[58,59],{"name":36,"role":40,"phone":41,"phoneExt":33,"email":42},{"name":36,"role":37,"phone":33,"phoneExt":33,"email":33},{"type":61,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[63],{"name":64,"class":65},"OraPharma","INDUSTRY","100615857","early-phase-1-effect-of-arestin-enhanced-srp-on-periodontal-and-glycemic-outcomes-in-diabetics-100615857",false,"NCT07298057","Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics","Effectiveness of Scaling and Root Planing With and Without Minocycline Microspheres (Arestin) in Improving Periodontal and Glycemic Outcomes in Diabetic Patients With Periodontitis: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Adults (≥18 years) with type 2 diabetes mellitus (HbA1c ≥ 7.0% and ≤9.5%)\n2. Diagnosed with moderate to severe periodontitis (≥5 mm probing pocket depth in at least 6 distinct interproximal sites, on different teeth)\n3. At least 16 teeth present\n4. No periodontal treatment in the last 6 months\n\nExclusion Criteria:\n\n1. Allergy to minocycline or tetracycline\n2. Unable to receive or to tolerate local anesthesia\n3. Unable to tolerate tooth instrumentation with ultrasonic instruments.\n4. Require IV sedation to receive scaling and root planing\n5. Use of antibiotics within the past 3 months\n6. Pregnancy or breastfeeding\n7. Morbid Obesity (BMI 40+)\n8. Smokers or patients with poorly controlled systemic diseases other than diabetes","ALL","18 Years",{"count":76,"type":77},42,"ESTIMATED","INTERVENTIONAL",[80],"EARLY_PHASE1","Periodontitis is a prevalent chronic inflammatory disease that exacerbates systemic inflammation and poses challenges for glycemic control in diabetic patients. While scaling and root planing (SRP) remains the cornerstone of periodontal therapy, adjunctive treatments such as Arestin (minocycline microspheres) have shown promise in enhancing clinical outcomes. This study aims to evaluate the impact of adding Arestin to SRP on periodontal pocket closure, glycemic control, and systemic inflammation in diabetic patients with periodontitis.",[83],"Periodontitis, Diabetes Mellitus Type 2",[30,85,86],"Arestin","Diabetes Mellitus Type 2","2026-02-18",{"date":89,"type":90},"2026-02-19","ACTUAL",{"date":92,"type":90},"2026-02-06",{"date":94,"type":77},"2028-06",{"name":5,"class":6},1]