Prospective Neodent® Zirconia System Study

Launched by NEODENT · Sep 10, 2020

Keywords

ClinConnect Summary

The Prospective Neodent® Zirconia System Study is a clinical trial focused on the Neodent® Zirconia Implant, which is designed to help replace missing teeth in patients who need dental implants. The main goal of this study is to evaluate how well these implants work over time and to ensure they are safe for long-term use in everyday dental practices. Participants will have their implants placed and will be monitored for three years to see how they perform.

To be eligible for this study, participants must be at least 18 years old and have missing back teeth in their upper jaw, with healthy natural teeth nearby. It's important to note that individuals who are pregnant, have certain medical conditions, or who struggle with specific health issues may not qualify. Throughout the study, patients can expect standard dental care and regular follow-ups to track the success of their implants. This research aims to provide valuable information on how well these new implants can help people restore their smiles and improve their oral health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older;
• • Maxillary posterior teeth missing, with adjacent natural teeth;
• • Patient who are in need of oral rehabilitation with dental implants and single prostheses and qualify for placement of Zirconia Implants.
• Exclusion Criteria:
• Subjects under 18 years of age, pregnant or breastfeeding women. And patients that present the device contraindications according to the IFU (instructions for use):
• • Signs of allergy or hypersensitivity to the chemical ingredients of the material: Zirconia (Y-ZTP), Zirconium dioxide (ZrO2), Yttrium oxide (Y2O3), Hafnium dioxide (HfO2), Aluminum oxide (Al2O3);
• • Acute inflammatory or infectious processes;
• • Unsuitable bone volume or quality;
• • Serious medical problems (e.g. bone metabolism disorders, blood clotting disorders, unsuitable healing capacity);
• • Incomplete jawbone growth;
• • Patient uncooperative and not motivated;
• • Hypochondria;
• • Alcoholism;
• • Psychosis;
• • Prolonged functional disorders which resist any treatment with medications;
• • Xerostomia;
• • Weakened immunological system;
• • Diseases which require regular use of steroids;
• • Uncontrolled endocrine diseases;
• • Insufficient oral hygiene;
• • Pregnancy;