NCT06792916 This Study Evaluates the Clinical Effect of Adding Spermidine Gel to Minimally Invasive Non-surgical Periodontal Therapy (MINST) to Improve Periodontal Health.
| NCT ID | NCT06792916 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Luca Ramaglia |
| Condition | Peridontitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2025-01-25 |
| Primary Completion | 2025-06-20 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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.