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This study investigates the effectiveness of using a spermidine-based gel as an adjunct to minimally invasive non-surgical periodontal therapy (MINST) for treating periodontitis. The primary outcome is to assess whether the addition of spermidine gel reduces pocket depth (PPD) compared to MINST alone. Secondary outcome include evaluating other periodontal parameters like bleeding on probing, FMBS and FMPS and CAL over a 12-month period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINST plus spermidine gel | Experimental |
| |
| MINST (minimally invasive non surgical tecnique) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spermidine and minimally invasive non surgical tecnique | Procedure | minimally non surgical periodontal therapy will be performed with the adjunct of spermidine based gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Probing depth (PD) | peridontal probing depth | From non surgical periodontal therapy to 6 months |
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Inclusion Criteria:
Age 18 years or older. Presence of untreated periodontitis with at least 2 sites showing clinical attachment loss (CAL) > 2 mm and probing depth (PD) > 4 mm.
Voluntary signing of informed consent.
Exclusion Criteria:
Presence of systemic diseases (e.g., diabetes mellitus, cardiovascular, renal, hepatic, or pulmonary conditions).
Smokers (≥10 cigarettes per day). Pregnancy or breastfeeding. Allergy to any ingredients in the products used in the study. Diseases affecting bone and/or connective tissue metabolism.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Ramaglia, Professor | Contact | 081-7462496 | luca.ramaglia@unina.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Federico II | Recruiting | Naples | Italy | 80013 | Italy |
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| peridontal therapy (minimally invasive non surgical tecnique) | Other | subgingival instrumentation will be performed according to MINST |
|
| ID | Term |
|---|---|
| D013095 | Spermidine |
| ID | Term |
|---|---|
| D011700 | Putrescine |
| D015317 | Biogenic Polyamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011073 | Polyamines |
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