Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| OraPharma | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | 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. |
|
| Control Group | Active Comparator | Scaling and Root Planing Alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| local antibiotic application of topical minocycline | Drug | Scaling and Root planing + local application of Arestin ( Minocycline microsphere) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pocket Closure | Pocket Depth (PD ≤4 mm) | Baseline, 3 Months, 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Glycemic Control (HbA1c) | Changes in Blood Sugar Level | Baseline, 3 Months, 6 Months |
| Changes in C-reactive Protein Level (CRP) | Changes in Systemic Inflammation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gian Pietro Schincaglia, DDS, PhD | Contact | 216-368-4412 | gxs486@case.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gian Pietro Schincaglia, DDS, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Recruiting | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 35420698 | Result | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D003924 | Diabetes Mellitus, Type 2 |
| C562573 | cyclopia sequence |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003920 | Diabetes Mellitus |
Not provided
Not provided
| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Scaling and Root Planing | Procedure | Only scaling and root planing |
|
| Baseline, 3 Months, 6 Months |
| 22057194 | Result | 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. |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |