Treatment for periodontal bone loss using amelogenins
Treatment of Intraosseous Periodontal Pockets by Non-surgical Therapy With Micro-instruments and Application of Amelogenins. A Randomized-controlled Clinical Trial
This study is testing if adding a special protein treatment to a common dental cleaning method can help people with gum disease heal better than just the cleaning alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT05315804 on ClinicalTrials.gov |
What this trial studies
This investigation aims to evaluate the healing of periodontal intraosseous defects by comparing two treatment approaches: Minimally Invasive Non Surgical Debridement (MINSD) combined with amelogenins versus MINSD alone. A total of 22 patients diagnosed with periodontitis will be randomly assigned to one of the two groups. The primary outcome measured will be the gain in Clinical Attachment Level (CAL), while secondary outcomes will include Probing Depth (PD), Gingival Recession (GR), and Radiographic Defect Angle (RDA). Patients will be monitored monthly for oral hygiene and will undergo evaluations after six months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with periodontitis and having specific periodontal conditions.
Not a fit: Patients with systemic diseases, those on prolonged antibiotic or anti-inflammatory treatments, or pregnant or lactating women may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance healing and improve clinical outcomes for patients with periodontal bone loss.
How similar studies have performed: Previous studies have shown promising results with similar approaches, but the specific use of amelogenins in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with periodontitis; * Age ≥ 18 years old; * Presence of at least 10 teeth per arch; * Presence of at least two teeth with Probing Depth (PD) ≥ 5 mm per quadrant; * Presence of at least one intraosseous pocket; * Single-rooted and multi-rooted teeth. Exclusion Criteria: * Patients with systemic diseases; * Prolonged antibiotic or anti-inflammatory treatment within 4 weeks prior to periodontal therapy; * Pregnant or lactating; * Tobacco smokers (≥ 10 cigarettes per day); * Multi-rooted teeth with furcation involvement; * Third molars.
Where this trial is running
Naples
- University of Naples Federico II — Naples, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Ramaglia — Federico II University
- 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.