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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 12 participants in total. It began in 2025-01-25 with a primary completion date of 2025-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06792916 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Peridontitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06792916 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06792916 currently recruiting?
Yes, NCT06792916 is actively recruiting participants. Contact the research team at luca.ramaglia@unina.it for enrollment information.
Where is the NCT06792916 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT06792916 clinical trial?
NCT06792916 is sponsored by Luca Ramaglia. The trial plans to enroll 12 participants.