NCT06287346

5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.

5-Years Multicentric Prospective Post-Market Clinical Follow-up (PMCF) Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 652 (estimated)
• Sponsor: CeraRoot SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth . The main question\[s\] it aims to answer are: * Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece (TL) variant? * What are the complications associated to the procedure and differences between the two groups.

Detailed description

The present clinical study protocol has the objective to compare the performance of different CeraRoot ceramic implant models (16,11,21,12,14,34,34L) and the different sub-variants (one-piece versus two-piece). The geographic population of study will be the patients in two different dental centers located in Barcelona (Spain) and Boulder (Colorado, USA). The intended population as described in the device instruction for use (3) is " Intended Population: All fully-grown patients (men or women) requiring dental reconstruction using dental implants and who have no contraindications. The CeraRoot® dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.

Conditions

• Edentulism
• Tooth Loss

Interventions

Type	Name	Description
DEVICE	dental implant	ceramic dental implant

Timeline

• Start date: 2024-01-01
• Primary completion: 2029-01-01
• Completion: 2030-01-01
• First posted: 2024-03-01
• Last updated: 2024-03-01

Locations

2 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated device study