Evaluating the effect of spermidine gel on periodontal health
Evaluation of Subgingival Mechanical Periodontal Therapy with the Additional Local Application of a Spermidine-Based Gel
This study is testing if a spermidine gel can help improve gum health and reduce pocket depth in people receiving non-surgical treatment for periodontitis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples, Italy) |
| Trial ID | NCT06792916 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a spermidine-based gel as an addition to minimally invasive non-surgical periodontal therapy (MINST) for treating periodontitis. The primary goal is to determine if the spermidine gel can significantly reduce pocket depth compared to MINST alone. Secondary outcomes include assessing other periodontal health indicators such as bleeding on probing and clinical attachment loss over a 12-month period. Participants will be monitored to evaluate the overall improvement in their periodontal health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with untreated periodontitis showing specific clinical attachment loss and probing depth.
Not a fit: Patients with systemic diseases, smokers, pregnant or breastfeeding women, or those with allergies to study products may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance periodontal health outcomes for patients suffering from periodontitis.
How similar studies have performed: While the use of spermidine in periodontal therapy is relatively novel, similar adjunct therapies have shown promise in improving periodontal outcomes in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Naples, Italy
- AOU Federico II — Naples, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Luca Ramaglia, Professor
- Email: luca.ramaglia@unina.it
- Phone: 081-7462496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.