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| ID | Type | Description | Link |
|---|---|---|---|
| Etics Commitee | Registry Identifier | Etics Commitee for Clinical Trials of the Provinces Verona and Rovigo |
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Evaluate from a clinical and microbiological point of view the effect of an adjunctive therapy based on a thermal-gelling device Pocket-X® Gel (Hyaluronic acid, Poloxamer, 2-Phenoxyethanol, Octedine HCL, Water), in the non-surgical treatment of periodontal defects, in a population of patients with T2DM compared to non-diabetic patients.
Determine whether periodontal defect healing is clinically and microbiologically different between T2DM patients and non-diabetic patients; whether periodontal treatment and maintenance can lead to improvement of conditions and stability over time also for diabetic conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gel therapy after non surgical therapy | Experimental | The test group will receive gel therapy immediately after non surgical treatment. The gel in use is a composition of Hyaluronic acid, Poloxamer, 2-Phenoxyethanol, Octedine HCL,Water (Pocket-X Gel Geistlich AG, Wolhusen, Switzerland). It is a patented liquid-to-gel device. Pocket-X® Gel is composed of: Poloxamer 407 with thermo-gelling properties, Octenidine, antimicrobial preservative, Hyaluronic acid to support tissue healing. |
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| Non surgical therapy | No Intervention | In the control group non surgical therapy was performed using mechanical and manual instrumentations (curettes and ultrasonic devices) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gel therapy after non surgical therapy | Device | The gel in use is a composition of Hyaluronic acid, Poloxamer, 2-Phenoxyethanol, Octedine HCL,Water (Pocket-X Gel Geistlich AG, Wolhusen, Switzerland). It is a patented liquid-to-gel device. Pocket-X® Gel is composed of: Poloxamer 407 with thermo-gelling properties, Octenidine, antimicrobial preservative, Hyaluronic acid to support tissue healing. It promotes gingival healing and prevents bacterial recolonization of periodontal pockets, forming a protective physical barrier, allows to postpone or avoid long, complex and painful surgeries, ensuring the success of periodontal treatment, delaying any surgical interventions. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation, in the test site and in the control site (for each of the two groups) of the periodontal index of: PPD in mm. | Clinical evaluation, in the test site and in the control site (for each of the two groups), at baseline and after 2 weeks, 1 month, and 3 months, by means of detection with a periodontal millimeter probe, of the periodontal index of: pocket probing depth (PPD), in mm. Detect whether the healing of periodontal defects is different from a clinical and microbiological point of view between patients with T2DM and non-diabetic patients; whether periodontal treatment and maintenance can bring improvement of conditions and stability over time also for the diabetic condition. | At baseline and after 2 weeks, 1 month, and 3 months |
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Inclusion Criteria:
Patients normally eligible for the visit and for the non-surgical type of treatment for periodontal defects:
Exclusion Criteria:
Patients not eligible for the non-surgical type of treatment for periodontal defects:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessia Pardo | Contact | +39 3494628471 | Alessia.pardo@univr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alessia Pardo 3494628471 Alessia.pardo@univr.it | Recruiting | Verona | Italy | 37134 | Italy |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The study is clinical, with the following characteristics: prospective, case-control, single-center, with a post-market device. The case group is represented by patients affected by controlled T2DM, the control group by non-diabetic patients.
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| D004700 | Endocrine System Diseases |