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Search / Trial NCT05315804

Treatment of Intraosseous Periodontal Defects With Amelogenins

Launched by FEDERICO II UNIVERSITY · Mar 30, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Amelogenin Periodontal Therapy Periodontal Bone Loss Intraosseous Bone Defect

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with periodontal bone loss, which is a condition that affects the gums and bone supporting the teeth. The trial aims to see if using a tooth protein called amelogenins, along with a specific cleaning technique called Minimally Invasive Non Surgical Debridement (MINSD), can help heal certain types of gum defects better than just using the cleaning technique alone. In this study, 22 patients with periodontitis, a serious gum disease, will be recruited and randomly assigned to receive either the amelogenins treatment or no additional treatment.

To be eligible for this trial, participants must be at least 18 years old, have at least 10 teeth in their mouth, and show signs of gum disease, including deep pockets around their teeth. However, those with certain health issues, recent antibiotic use, or those who smoke heavily won't be able to participate. If someone joins the trial, they can expect to undergo the MINSD cleaning procedure and receive either the amelogenins treatment or standard care, while being closely monitored for healing over time. This study is a great opportunity to explore new ways to improve gum health and could lead to better treatment options for patients in the future.

Gender

ALL

Eligibility 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.

About Federico Ii University

Federico II University, located in Naples, Italy, is a prestigious academic institution with a strong emphasis on advanced research and clinical innovation. As a clinical trial sponsor, the university is committed to fostering the development of novel therapeutic interventions and enhancing patient care through rigorous scientific inquiry. With a multidisciplinary approach, Federico II University collaborates with healthcare professionals, researchers, and industry partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory requirements. Its dedication to improving health outcomes is reflected in its robust research programs and commitment to translating scientific findings into clinical practice.

Locations

Naples, , Italy

Patients applied

0 patients applied

Trial Officials

Luca Ramaglia

Principal Investigator

Federico II University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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