[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07298057":3,"trial-entities:NCT07298057":100,"trial-summary:NCT07298057":105},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":45,"secondary_outcomes":50,"sex":57,"minimum_age":58,"maximum_age":17,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":64,"locations":67,"central_contacts":84,"overall_officials":86,"references":88,"see_also_links":99},"NCT07298057","STUDY20250753","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","RECRUITING","2028-06","2026-02","2026-02-19","2026-02-06","Case Western Reserve University","OTHER",true,"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.",null,[19],"Periodontitis, Diabetes Mellitus Type 2",[21,22,23],"Scaling and Root Planing","Arestin","Diabetes Mellitus Type 2","INTERVENTIONAL","TREATMENT",[27],"EARLY_PHASE1",{"count":29,"type":30},42,"ESTIMATED",[32,40],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","local antibiotic application of topical minocycline","Scaling and Root planing + local application of Arestin ( Minocycline microsphere)",[37],"Test Group",[39],"Arestin Minocicline microsphere",{"type":41,"name":21,"description":42,"armGroupLabels":43},"PROCEDURE","Only scaling and root planing",[44],"Control Group",[46],{"measure":47,"description":48,"timeFrame":49},"Pocket Closure","Pocket Depth (PD ≤4 mm)","Baseline, 3 Months, 6 Months",[51,54],{"measure":52,"description":53,"timeFrame":49},"Changes in Glycemic Control (HbA1c)","Changes in Blood Sugar Level",{"measure":55,"description":56,"timeFrame":49},"Changes in C-reactive Protein Level (CRP)","Changes in Systemic Inflammation","ALL","18 Years",false,{"inclusion":61,"exclusion":62,"raw_text":63},[],[],"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",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":13,"status":8,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":81},"Cleveland","Ohio","44106","United States",[74,79],{"name":75,"role":76,"phone":77,"email":78},"Gian Pietro Schincaglia, DDS, PhD","CONTACT","216-368-4412","gxs486@case.edu",{"name":75,"role":80},"PRINCIPAL_INVESTIGATOR",{"lat":82,"lon":83},41.4995,-81.69541,[85],{"name":75,"role":76,"phone":77,"email":78},[87],{"name":75,"affiliation":13,"role":80},[89,93,96],{"pmid":90,"type":91,"citation":92},"15536785","RESULT","Skaleric U, Schara R, Medvescek M, Hanlon A, Doherty F, Lessem J. Periodontal treatment by Arestin and its effects on glycemic control in type 1 diabetes patients. J Int Acad Periodontol. 2004 Oct;6(4 Suppl):160-5.",{"pmid":94,"type":91,"citation":95},"35420698","Simpson TC, Clarkson JE, Worthington HV, MacDonald L, Weldon JC, Needleman I, Iheozor-Ejiofor Z, Wild SH, Qureshi A, Walker A, Patel VA, Boyers D, Twigg J. Treatment of periodontitis for glycaemic control in people with diabetes mellitus. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD004714. doi: 10.1002\u002F14651858.CD004714.pub4.",{"pmid":97,"type":91,"citation":98},"22057194","Preshaw PM, Alba AL, Herrera D, Jepsen S, Konstantinidis A, Makrilakis K, Taylor R. Periodontitis and diabetes: a two-way relationship. Diabetologia. 2012 Jan;55(1):21-31. doi: 10.1007\u002Fs00125-011-2342-y. Epub 2011 Nov 6.",[],{"nct_id":4,"conditions":101,"biomarkers":104},[102,103],"Periodontitis","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":106,"prompt_version":116},{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This study is interventional and plans to enroll 42 participants. It compares two treatments: Scaling and Root Planing (SRP) alone versus SRP with the addition of Arestin.","completed","Arestin-Enhanced SRP for Periodontitis and Diabetes","This study is looking at how adding Arestin (minocycline microspheres), a local antibiotic, to a common dental cleaning procedure called Scaling and Root Planing (SRP) affects people with type 2 diabetes and gum disease (periodontitis). Researchers want to see if this combination treatment helps close gum pockets, improves blood sugar control, and reduces overall body inflammation. You might be able to join if you are an adult (18 or older) with type 2 diabetes (HbA1c between 7.0% and 9.5%) and moderate to severe periodontitis. You also need at least 16 teeth and no recent gum treatment. The study aims to enroll 42 participants, but its current status is unclear.","Participants will be followed for 6 months after treatment, with measurements taken at 3 and 6 months.",109,"You would receive either Scaling and Root Planing (SRP) alone or SRP with Arestin. Your gum pocket closure will be measured at the start, after 3 months, and after 6 months.","Not stated in the trial record.",[21],"v2"]