Using a spermidine gel to treat peri-implant mucositis
Treatment of Peri-implant Mucositis by Non-surgical Debridement and Additional Application of a Spermidine-based Gel
This study is testing if a spermidine gel can help people with peri-implant mucositis heal better when used alongside regular cleaning treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT05926557 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a spermidine-based topical gel as an additional treatment for peri-implant mucositis alongside non-surgical debridement. Patients will be randomly assigned to either the Test group, receiving the spermidine gel after mechanical therapy, or the Control group, which will only undergo mechanical therapy. Clinical parameters will be recorded before and after treatment to assess the gel's impact on healing. Data analysis will utilize statistical software to determine the outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with at least one implant showing signs of mucositis.
Not a fit: Patients with cancer, uncontrolled diabetes, or those on prolonged antibiotic or anti-inflammatory treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve healing and reduce inflammation in patients with peri-implant mucositis.
How similar studies have performed: While the use of spermidine in oral health is emerging, this specific application for peri-implant mucositis is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years; * Non-smokers and smokers ( ≤ 10 cigarettes/day); * Presence of at least 1 implant in mucositis, clinically and radiographically detected; * The implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown), cemented or screwed. Exclusion Criteria: * Cancer patients; * Periodontally Compromised Patients; * Uncontrolled diabetic patients; * Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months; * Pregnant or breastfeeding patients; * Implants that support mobile prosthetic products; * Implants in peri-implantitis, detected clinically and radiographically.
Where this trial is running
Naples
- University of Naples Federico II — Naples, Italy (Recruiting)
Study contacts
- Study coordinator: Luca Ramaglia
- Email: luca.ramaglia@unina.it
- Phone: +393476912911
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.