Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-29 @ 11:34 PM
Study NCT ID:
NCT07298057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'C562573', 'term': 'cyclopia sequence'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pocket Closure', 'timeFrame': 'Baseline, 3 Months, 6 Months', 'description': 'Pocket Depth (PD ≤4 mm)'}], 'secondaryOutcomes': [{'measure': 'Changes in Glycemic Control (HbA1c)', 'timeFrame': 'Baseline, 3 Months, 6 Months', 'description': 'Changes in Blood Sugar Level'}, {'measure': 'Changes in C-reactive Protein Level (CRP)', 'timeFrame': 'Baseline, 3 Months, 6 Months', 'description': 'Changes in Systemic Inflammation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scaling and Root Planing', 'Arestin', 'Diabetes Mellitus Type 2'], 'conditions': ['Periodontitis, Diabetes Mellitus Type 2']}, 'referencesModule': {'references': [{'pmid': '15536785', 'type': 'RESULT', 'citation': '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': '35420698', 'type': 'RESULT', 'citation': '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: 10.1002/14651858.CD004714.pub4.'}, {'pmid': '22057194', 'type': 'RESULT', 'citation': '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/s00125-011-2342-y. Epub 2011 Nov 6.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07298057', 'briefTitle': 'Effect of Arestin-Enhanced SRP on Periodontal and Glycemic Outcomes in Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'STUDY20250753'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Group', 'description': 'Minocycline microspheres (Arestin®) / (4 mg per cartridge) prefilled delivery syringe / Arestin will be placed in the pocket only one time after scaling and root planing.', 'interventionNames': ['Drug: local antibiotic application of topical minocycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Scaling and Root Planing Alone', 'interventionNames': ['Procedure: Scaling and Root Planing']}], 'interventions': [{'name': 'local antibiotic application of topical minocycline', 'type': 'DRUG', 'otherNames': ['Arestin Minocicline microsphere'], 'description': 'Scaling and Root planing + local application of Arestin ( Minocycline microsphere)', 'armGroupLabels': ['Test Group']}, {'name': 'Scaling and Root Planing', 'type': 'PROCEDURE', 'description': 'Only scaling and root planing', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Gian Pietro Schincaglia, DDS, PhD', 'role': 'CONTACT', 'email': 'gxs486@case.edu', 'phone': '216-368-4412'}, {'name': 'Gian Pietro Schincaglia, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Gian Pietro Schincaglia, DDS, PhD', 'role': 'CONTACT', 'email': 'gxs486@case.edu', 'phone': '216-368-4412'}], 'overallOfficials': [{'name': 'Gian Pietro Schincaglia, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Participant Data (IPD) will not be shared with other researchers. Only de-identified, cumulative data (summary-level results) will be shared with the study sponsor (OraPharma) after study completion. No identifiable participant information such as name, date of birth, or contact details will be disclosed. All collected data will remain securely stored within Case Western Reserve University and will only be accessed by the study investigators and authorized university or regulatory personnel.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'collaborators': [{'name': 'OraPharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}